Topicale
Benzocaine
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| Med-Dent Solutions Corp | 5 | Y | 2026-01-01 | 10920 W Flagler St Ste 205 Miami FL US 33174 | ||
| MEDCAVE PRIVATE LIMITED | 5 | N | 2026-01-01 | Jinnah Town, Capital Road, Sialkot Punjab PK 51310 | ||
| Medline Soluciones Medicas | 5 | N | 2026-01-01 | New York 303 Parque Industrial Oradel Nuevo Laredo Tamaulipas MX 88285 | ||
| MEDOVATE LLC | 5 | Y | 2026-01-01 | 200 Texas Ave Brownsville TX US 78521 | ||
| MEDIPRIME SUPPLY INC. | 5 | Y | 2026-01-01 | 335 S Schnoor Ave Ste 117 Madera CA US 93637 | ||
| 1016498 | 1016498 | MEDICAL SPECIALTIES, INC. | 1 | N | 2026-01-01 | 308 Parson Street WADESBORO NC US 28170 |
| 1030451 | 1030451 | MEDICAL ACTION INDUSTRIES, INC. 306 | 1 | Y | 2026-01-01 | 25 HEYWOOD RD. ARDEN NC US 28704 |
| 1030489 | 1000477302 | MEDTRONIC SOFAMOR DANEK USA, INC. | 1 | Y | 2026-01-01 | 1800 PYRAMID PLACE Memphis TN US 38132 |
| 1033601 | 1033601 | MEDICOMP, INC. | 1 | Y | 2026-01-01 | 600 Atlantis Rd -- Melbourne FL US 32904 |
| 1038823 | 1038823 | MEDICAL ENERGY, INC. | 1 | N | 2026-01-01 | 8806 PAUL STARR DR. PENSACOLA FL US 32514 |
| 1043646 | 1043646 | Medegen Medical Products | 1 | Y | 2026-01-01 | 209 MEDEGEN DR. GALLAWAY TN US 38036 |
| 1045254 | 1045254 | MEDTRONIC XOMED, INC. | 1 | N | 2026-01-01 | 6743 SOUTHPOINT DR. NORTH Jacksonville FL US 32216 |
| 1050155 | 1050155 | MEDTOX DIAGNOSTICS, INC. | 1 | N | 2026-01-01 | 1238 Anthony Rd BURLINGTON NC US 27215 |
| 1052939 | 1000113887 | Medidenta | 1 | Y | 2026-01-01 | 3575 W Post Rd Las Vegas NV US 89118 |
| 1058264 | 1000307595 | MEDRX, INC. | 1 | N | 2026-01-01 | 1200 Starkey Rd Ste 105 LARGO FL US 33771 |
| 1063312 | 3000719631 | MEDI MFG., INC. | 1 | N | 2026-01-01 | 6481 FRANZ WARNER PKWY. WHITSETT NC US 27377 |
| 1064371 | 3002865793 | MEDONE SURGICAL, INC. | 1 | Y | 2026-01-01 | 670 TALLEVAST ROAD SARASOTA FL US 34243 |
| 1066419 | 3003394285 | MEDISTIM USA, INC. | 1 | Y | 2026-01-01 | 14000 25th Ave. N. Ste. 108 Plymouth MN US 55447 |
| 1066420 | 3003394302 | Medgluv Inc | 1 | Y | 2026-01-01 | 4100 Coral Ridge Drive Suite 100 Coral Springs FL US 33065 |
| 1066438 | 3003400750 | Medical Technology Products. Inc. | 1 | Y | 2026-01-01 | 7211 Haverhill Bus. Pkwy. Riviera Beach FL US 33407 |
| 1066648 | 3003244344 | MEDIPURPOSE, INC. | 1 | Y | 2026-01-01 | 2862 Buford Hwy Ste 105 Duluth GA US 30096 |
| 1066698 | 3002886224 | MED-EXPRESS, INC. | 1 | Y | 2026-01-01 | 248 Mills Gap Rd Fletcher NC US 28732 |
| 1066702 | 3003370917 | MED-EL CORP. | 1 | Y | 2026-01-01 | 2645 Meridian Pkwy Ste 100 DURHAM NC US 27713 |
| 1066959 | 3003434195 | MEDICAL SPECIALTIES INC. | 1 | Y | 2026-01-01 | 3874 South Alston Ave Suite 103 DURHAM NC US 27713 |
| 1123459 | 1000136413 | MEDISPEC, LTD. | 1 | Y | 2026-01-01 | 203 Perry Pkwy Ste 6 Gaithersburg MD US 20877 |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 5761 | 1954472080 | P970015 | INTER FIX THREADED FUSION DEVICE | MAX | 1999-05-14 |
| 5761 | 1520450386 | P090029 | PRESTIGE LP CERVICAL DISC | MJO | 2014-07-24 |
| 5761 | 1296359699 | P060023 | BRYAN CERVICAL DISC PROSTHESIS | MJO | 2009-05-12 |
| 5761 | 2030597229 | P060018 | PRESTIGE CERVICAL DISC SYSTEM | MJO | 2007-07-16 |
| 5761 | 2037408517 | P050053 | INFUSE BONE GRAFT | NPZ | 2007-03-09 |
| 5761 | 1721901068 | P040001 | X STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM | NQO | 2005-11-21 |
| 5761 | 1596660047 | P000058 | INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE | NEK | 2002-07-02 |
| 5761 | 2017034195 | P000054 | INFUSE BONE GRAFT | MPW | 2004-04-30 |
| 5761 | 1935647279 | P000028 | AFFINITY (TM) CAGE SYSTEM | MAX | 2002-06-13 |
| 5760 | 1328856170 | K994262 | FRONTAL SINUS TREPHINATION CANNULA | KAM | 2000-02-08 |
| 5761 | 1791905019 | K994239 | ZEPHIR ANTERIOR CERVICAL PLATE SYSTEM | KWQ | 2000-06-19 |
| 5761 | 1942544278 | K994122 | BONE GRAFT WASHER, MODEL 9090114 - 9090118 | KWQ | 2000-02-18 |
| 5761 | 1331165389 | K993855 | ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM | KWQ | 1999-12-15 |
| 5761 | 2018734928 | K993810 | CD HORIZON SPINAL SYSTEM | MNH | 2000-02-03 |
| 5760 | 1062976338 | K993021 | METRX SYSTEM | HRX | 1999-11-10 |
| 5761 | 1062976338 | K993021 | METRX SYSTEM | HRX | 1999-11-10 |
| 5761 | 1283829531 | K992928 | CD HORIZON SPINAL SYSTEM | MNI | 1999-09-21 |
| 5760 | 1397726877 | K992869 | XOMED BALL-TIP MONOPOLAR STIMULATOR PROBE | ETN | 1999-10-07 |
| 5760 | 1503347285 | K992855 | XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM OR XPS POWERSCULPT | QPB | 2000-01-21 |
| 29178 | 1892676434 | K992111 | VERDICT -II OPIATES 2000 | DJG | 1999-12-16 |
| 5761 | 1999960604 | K992110 | PREMIER ANTERIOR CERVICAL PLATE SYSTEM | KWQ | 1999-09-14 |
| 5760 | 1459382288 | K991560 | NASO-LARYNGO-PHARYNGOSCOPE | EOB | 1999-07-13 |
| 5761 | 1521473404 | K991528 | MODIFICATION TO TENOR SPINAL SYSTEM-ROD/BOLT CONNECTOR | MNH | 1999-05-28 |
| 5761 | 1015159206 | K991460 | MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM | MNH | 1999-05-19 |
| 5761 | 1651344753 | K991364 | MODIFICATION TO TENOR SPINAL SYSTEM-PLATES | MNH | 1999-05-19 |
| 5761 | 1687414764 | K991198 | DYNA-LOK PLUS SPINAL SYSTEM | KWP | 1999-08-27 |
| 5761 | 1010808771 | K991036 | DANEK PLATE AND SCREW SYSTEM | MNH | 1999-09-14 |
| 5761 | 1490627623 | K991031 | COLORADO II SPINAL SYSTEM | MNH | 2000-05-10 |
| 5760 | 1800596642 | K990793 | ACCUGUIDE MUSCLE INJECTION MONITOR | GXZ | 1999-10-22 |
| 5761 | 2002677408 | K990603 | MODIFICATION OF THE ZPLATE-ATL ANTERIOR FIXATION SYSTEM | KWQ | 1999-03-10 |
| 5761 | 1258968485 | K984522 | MODIFICATION OF TSRH SPINAL SYSTEM | MNI | 1999-01-06 |
| 5761 | 1387689553 | K984360 | COLORADO II SPINAL SYSTEM | MNH | 2000-03-30 |
| 5761 | 1753808401 | K983706 | MODIFICATION OF TOWNLEY PEDICLE SCREW PLATING SYSTEM | KWP | 1998-11-12 |
| 5761 | 1415003778 | K983672 | DYNA-LOK SPINAL SYSTEM | MNI | 1998-12-16 |
| 5760 | 1150667316 | K983224 | XPS DRILL SYSTEM | ERL | 1998-10-21 |
| 5760 | 1398418079 | K983025 | XOMED FEATHERTOUCH XPS POWER RASP ATTACHMENT | HRX | 1998-11-06 |
| 5761 | 1960338766 | K982990 | TSRH SPINAL SYSTEM | MNI | 1998-10-21 |
| 5761 | 2068018505 | K982875 | MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM | KWQ | 1999-01-19 |
| 5761 | 1520150763 | K982686 | MODIFICATION TO TOWNLEY PEDICLE SCREW PLATING SYSTEM | MNI | 1998-08-07 |
| 5760 | 1220465798 | K982595 | NIM4 | ETN | 1998-09-04 |
| 5760 | 1853204947 | K982594 | ENDO-SCRUB/ENDO-SCRUB 2 | EOB | 1998-08-27 |
| 5761 | 1720810943 | K982490 | TENOR SPINAL SYSTEM | KWP | 1998-10-05 |
| 29178 | 1016474543 | K982211 | PROFILE-II MODEL 600582 | DKE | 1998-07-29 |
| 5761 | 2015589731 | K982154 | MODIFICATION OF TOWNLEY PEDICLE SCREW PLATING SYSTEM | MNI | 1998-07-13 |
| 5760 | 1518194036 | K981677 | REPOSE BONE SCREW SYSTEM | LRK | 1999-08-27 |
| 5761 | 1585121147 | K981676 | CD HORIZON SPINAL SYSTEM | KWP | 1999-01-28 |
| 5761 | 1549180464 | K981251 | KYPHON INFLATABLE BONE TAMP | HRX | 1998-07-02 |
| 5761 | 1537207222 | K980184 | CD SPINAL SYSTEM | MNI | 1998-12-18 |
| 5760 | 1985956407 | K974187 | STEALTHSTATION SYSTEM | HAW | 1998-01-21 |
| 5761 | 1971712798 | K973854 | ORION ANTERIOR CERVICAL PLATE SYSTEM | KWQ | 1998-03-16 |
| 5760 | 1874109202 | K973499 | XPS STRAIGHTSHOT MICROBRIDER SYSTEM OR TREBAY SHAVER SYSTEM | HRX | 1998-01-30 |
| 5760 | 1113290151 | K972398 | STEALTHSTATION PASSIVE INSTRUMENT OPTION | HAW | 1997-09-16 |
| 185712 | 2048640649 | K971645 | REGANES SPINAL NEEDLE (VARIOUS) | MIA | 1997-08-01 |
| 185712 | 1814943729 | K971281 | RAULERSON ONE-STEP GUIDEWIRE INSERTION BULB NEEDLE | DQX | 1997-10-09 |
| 5760 | 1381244291 | K970910 | XOMED SILICONE BLOCK/STRIP | KHJ | 1997-05-02 |
| 185712 | 1313586297 | K970889 | ULTRASOUND TRANSDUCER DRAPE | KKX | 1997-10-20 |
| 5761 | 1736191801 | K970806 | ACPII ANTERIOR CERVICAL PLATE SYSTEM | KWQ | 1997-05-02 |
| 5761 | 1409848288 | K970599 | TOWNLEY PEDICLE SCREW PLATING SYSTEM | MNI | 1998-03-20 |
| 5760 | 1389091070 | K965233 | SHARPSITE AC | EOB | 1997-04-04 |
| 5761 | 1891189775 | K965193 | LIBERTY ANTERIOR SPINAL SYSTEM | KWQ | 1997-03-17 |
| 5761 | 1790811986 | K964623 | TITANIUM CD HORIZON ANTERIOR SPINAL SYSTEM | KWQ | 1997-02-06 |
| 5760 | 1211614213 | K964484 | KARTUSH TM PATCHER | KHJ | 1997-01-24 |
| 5761 | 1154504240 | K964275 | ALPHA POSTERIOR SPINAL SYSTEM | KWP | 1997-01-14 |
| 5761 | 1806894514 | K964254 | TITANIUM LIBERTY POSTERIOR SPINAL SYSTEM | KWP | 1997-04-21 |
| 5761 | 1412875585 | K964159 | CD SPINAL SYSTEM | KWP | 1997-10-16 |
| 5761 | 1850025970 | K963780 | DUAL ROD ANTERIOR FIXATOR SYSTEM | KWQ | 1997-07-30 |
| 5761 | 1462676179 | K963655 | CD HORIZON ANTERIOR SPINAL SYSTEM | KWQ | 1996-11-27 |
| 5761 | 1373748860 | K963642 | INCL II ENDOSCOPE | GWG | 1998-03-18 |
| 5760 | 1694596679 | K963246 | TREBAY MICRODEBRIDER OR XPS STRAIGHT SHOT | ERL | 1996-09-23 |
| 5761 | 1846753732 | K962708 | TITANIUM CD HORIZON SPINAL SYSTEM | KWP | 1997-02-06 |
| 5760 | 1293659564 | K961873 | ACTIVENT ANTIMICROBIAL VENTILATION TUBES | ETD | 1996-07-01 |
| 5761 | 1563922525 | K961633 | CD HORIZON SPINAL SYSTEM | KWP | 1996-12-05 |
| 185712 | 1744921775 | K961225 | CONTINUFLO SOLUTION SET/SECONDARY MEDICATION SET | FPA | 1996-06-21 |
| 13545 | 2070735805 | K960997 | STARSWAB CULTURE COLLECTION AND TRANSPORT SYSTEM | LIO | 1996-04-03 |
| 5760 | 1537758234 | K960853 | ACE SYSTEM | EQJ | 1996-04-03 |
| 5761 | 1043362474 | K955807 | COTREL-DUBOUSSET (CD) SPINAL | KWP | 1996-10-01 |
| 5761 | 1642468742 | K955471 | INCL ENDOSCOPE | HRX | 1995-12-18 |
| 5761 | 1157825981 | K955365 | COMPACT COTREL-DUBOUSSET (CCD) SPINAL SYSTEM | KWP | 1996-03-27 |
| 5761 | 1697709122 | K954645 | TITANIUM GDLH POSTERIOR SPINAL SYSTEM | KWP | 1996-01-16 |
| 5761 | 1466048614 | K953635 | TITANIUM DYNA-LOK SPINAL SYSTEM | MNH | 1995-10-30 |
| 185712 | 1945135613 | K953573 | ICU STOPCOK WITH EXTENSION TUBING | FMG | 1995-10-07 |
| 5761 | 1254120006 | K953076 | TOWNLEY FACET/PEDICULAR SCREW PLATING SYSTEM | MRW | 1997-02-28 |
| 5761 | 1706553644 | K951164 | CD LIBERTY POSTERIOR SPINCAL SYSTEM | KWP | 1996-02-09 |
| 5761 | 1596499608 | K950955 | PARAGON POSTERIOR SPINAL SYSTEM | MNH | 1995-08-25 |
| 5761 | 1089783813 | K950717 | AUGMENT-T POSTERIOR SPINAL SYSTEM | MNH | 1996-02-14 |
| 5761 | 1726152151 | K950596 | GDLH POSTERIOR SPINAL SYSTEM | MNH | 1995-08-28 |
| 5761 | 1256492282 | K950501 | DANEK RIGID ARTHROSCOPE | HRX | 1995-05-12 |
| 5761 | 1138758898 | K950130 | MICRO-ENDO(TM) INSTRUMENTS | HRX | 1995-05-01 |
| 5761 | 1277445944 | K946348 | TITANIUM TSRH(R) SPINAL SYSTEM (SCREWS) | MNH | 1995-08-07 |
| 5761 | 1367893110 | K946087 | INCLUSICE II(TM) ENDOSCOPE | HRX | 1995-11-21 |
| 5761 | 1744379142 | K945022 | APOFIX CERVICAL SPINE FIXATION | KWP | 1995-05-15 |
| 5761 | 1937209296 | K943827 | SPINE FIXATION | MNH | 1996-02-14 |
| 5761 | 1629683869 | K943676 | DANEKSCOPE OPTI-PROBE | HRX | 1994-11-21 |
| 13545 | 1007523286 | K943499 | KULTSURE STARSWAB(M240), MODIFICATION | JSM | 1994-11-30 |
| 5761 | 1538231040 | K943356 | INCLUSIVE ENDOSCOPE | HRX | 1995-05-10 |
| 13545 | 1588051666 | K942054 | SHARPS-TAINER | FMI | 1994-08-23 |
| 5760 | 1847555675 | K941407 | TYMPANOSTOMY (VENTILATION) TUBE | ETD | 1995-03-14 |
| 5761 | 1945533144 | K940744 | SOFAMOR, LAURAIN DEWALD ANTERIOR FIXATION | KWQ | 1996-01-30 |
| 5760 | 1091938364 | K940028 | ENDOSCOPE SHEATH | EOB | 1995-03-24 |
| 5761 | 1872218526 | K936307 | DYNA-LOK ANTERIOR PLATING SYSTEM | MNH | 1995-08-14 |
| 5761 | 1421175831 | K936294 | SENTRY(TM) ANTERIOR/POSTERIOR SPINAL SYSTEMS | KWP | 1995-12-19 |
| 5761 | 1298784237 | K934582 | GDLH VARIABLE ANGLE CONNECTOR | KWP | 1994-06-21 |
| 5760 | 1348316892 | K934426 | NERVE INTEGRITY MONITOR-2 (NIM-2 XL) | ETN | 1994-05-13 |
| 5761 | 1163323272 | K934007 | SOFAMOR ORFIL SPINE FIXATION SYSTEM | KWP | 1994-06-02 |
| 5761 | 1375419596 | K933242 | SOFAMOR ORTHOPAEDIC INSTRUMENTS | LXH | 1994-01-28 |
| 5761 | 1260853652 | K933205 | TSRH(R) TOP TIGHT T-BOLT-VARI ANGLE/SCREW/PARAGON | KWP | 1994-05-04 |
| 185712 | 1888787381 | K932449 | DR. FOG | OCT | 1993-08-11 |
| 5761 | 1340568189 | K932029 | TSRH SPINAL SCREWS | MNH | 1995-01-20 |
| 5761 | 1291644670 | K930807 | SENTRY ANTERIOR SPINAL SYSTEM | KWQ | 1993-10-01 |
| 5761 | 1190629329 | K930710 | SENTRY POSTERIOR SPINAL SYSTEM | KWP | 1993-10-01 |
| 5761 | 1845030859 | K930191 | DANEK(TM) SPINAL EPIDURAL ENDOSCOPIC SY | HRX | 1995-09-26 |
| 5761 | 1413631021 | K925812 | TITANIUM SONGER CABLE SYSTEM | JDQ | 1993-03-24 |
| 5761 | 1935086727 | K925811 | TSRH CENTRAL POST HOOKS | KWP | 1993-05-18 |
| 5760 | 1821878454 | K925640 | XOMED-TREACE EMG ENDOTRACHEAL TUBEEN | ETN | 1993-08-17 |
| 350713 | 1668467939 | K925591 | MERIDIAN MEDICAL SYSTEMS HYPER INFLATION BAY SYST | BZR | 1993-09-16 |
| 5761 | 1181836011 | K925577 | DANEK TISSUE RESECTING SYSTEM | HRX | 1993-04-08 |
| 350713 | 1411458861 | K925217 | MERIDIAN MEDICAL SYSTEMS BREATHING FILTER | CAH | 1993-01-26 |
| 5761 | 1215798237 | K924085 | RECONSTRUCTION PLATE SYSTEM | HRS | 1992-12-17 |
| 5761 | 1378087995 | K923446 | STERILE DYNA LOK ANTERIOR PLATING SYSTEM | KWQ | 1992-12-17 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| KWP | 108 | 2013-04-01 |
| NKB | 97 | 2026-04-21 |
| MAX | 51 | 2022-04-12 |
| KWQ | 47 | 2015-11-12 |
| MQP | 38 | 2019-04-04 |
| MNI | 34 | 2006-12-22 |
| MNH | 33 | 2006-07-25 |
| HRX | 26 | 2015-07-23 |
| ETN | 19 | 2026-02-10 |
| OLO | 15 | 2023-07-18 |
| ODP | 12 | 2019-08-16 |
| MQV | 12 | 2015-08-14 |
| OVD | 10 | 2024-10-28 |
| ERL | 10 | 2015-08-14 |
| EOB | 9 | 2018-04-20 |
| OVE | 8 | 2019-08-06 |
| DJG | 7 | 2026-01-29 |
| NDN | 7 | 2022-04-18 |
| NQP | 7 | 2021-01-15 |
| HBE | 7 | 2018-10-04 |
| JDK | 6 | 2001-10-10 |
| ETA | 6 | 1991-06-21 |
| NKG | 5 | 2026-01-21 |
| GEI | 5 | 2024-02-28 |
| GWF | 5 | 2020-10-28 |
| LXB | 5 | 2016-06-16 |
| ETD | 5 | 2015-07-22 |
| LYC | 5 | 2014-06-10 |
| MRW | 5 | 2010-10-22 |
| GXZ | 5 | 2007-08-21 |
| ETB | 5 | 2000-10-11 |
| MBP | 4 | 2013-03-06 |
| NUN | 4 | 2008-07-18 |
| DIS | 4 | 2003-11-10 |
| JDQ | 4 | 1993-03-24 |
| PML | 3 | 2020-08-19 |
| PGM | 3 | 2015-02-25 |
| HAW | 3 | 2013-08-07 |
| DKZ | 3 | 2009-02-13 |
| EOX | 3 | 2007-08-29 |
Benzocaine
Benzocaine
Benzocaine
Benzocaine
Benzocaine
Benzocaine
Benzocaine
Benzocaine
Benzocaine
Benzocaine
Aluminium Chloride Hexahydrate
salicylic acid and benzocaine
Witch Hazel
Carbon Dioxide
Nitrous Oxide
Air
Oxygen
NITROGEN
Oxygen Carbon Dioxide
Isopropyl Alcohol
Tincture of Benzoin
Benzalkonium Chloride
Ethyl Alcohol
Ethyl Alcohol
HYDROGEN PEROXIDE
HYDROGEN PEROXIDE
Isopropyl Alcohol
Indium In-111 Oxyquinoline
TECHNETIUM TC-99M EXAMETAZIME
Tetrofosmin
Technetium Tc-99m Exametazime and Cobaltous Chloride
Tetrofosmin
Ioflupane I-123
Iobenguane I-123
Indium In-111 Pentetate Disodium
TIROFIBAN
TIROFIBAN
Pitavastatin Magnesium
Pitavastatin Magnesium
TIROFIBAN
MEDTRONIC Inc.8200 Coral Sea Street Nems Mv S11mounds View, MN 55112 PMA NumberP010015 Supplement NumberS513 Date Received01/23/2023 Decision Date02/03/2023 Product Code LWP Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason P...
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT8200 Coral Sea Street N.e.mounds View, MN 55112 PMA NumberP010031 Supplement NumberS813 Date Received01/23/2023 Decision Date02/03/2023 Product Code NIK Advisory Committee Cardiovascular Supplement Type30-day Noti...
MEDTRONIC Inc.8200 Coral Sea Street Nems Mv S11mounds View, MN 55112 PMA NumberP980035 Supplement NumberS739 Date Received01/23/2023 Decision Date02/03/2023 Product Code NVZ Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason P...
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT8200 Coral Sea Street N.e.ms Mvs11mounds View, MN 55112 PMA NumberP980016 Supplement NumberS847 Date Received01/23/2023 Decision Date02/03/2023 Product Code LWS Advisory Committee Cardiovascular Supplement Type30-...
MEDTRONIC NEUROMODULATION7000 Central Avenue Neminneapolis, MN 55432 PMA NumberP840001 Supplement NumberS536 Date Received01/20/2023 Decision Date02/02/2023 Product Code LGW Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Proces...
MEDTRONIC Inc.7000 Central Avenue Neminneapolis, MN 55432-3576 PMA NumberP960009 Supplement NumberS446 Date Received01/20/2023 Decision Date02/02/2023 Product Code MHY Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Chan...
Medtronic8200 Coral Seast. N.e.mounds View, MN 55112 PMA NumberP100047 Supplement NumberS205 Date Received01/19/2023 Decision Date02/02/2023 Product Code DSQ Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - ...
Medtronic, Inc.710 Medtronic Parkwayminneapolis,, MN 55432 PMA NumberP130021 Supplement NumberS131 Date Received01/27/2023 Decision Date01/29/2023 Product Code NPT Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Cha...
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT8200 Coral Sea Street N.e.mounds View, MN 55112 PMA NumberP010031 Supplement NumberS812 Date Received01/19/2023 Decision Date01/26/2023 Product Code NIK Advisory Committee Cardiovascular Supplement Type30-day Noti...
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT8200 Coral Sea Street N.e.ms Mvs11mounds View, MN 55112 PMA NumberP980016 Supplement NumberS846 Date Received01/19/2023 Decision Date01/26/2023 Product Code LWS Advisory Committee Cardiovascular Supplement Type30-...
Medtronic CryoCath LP8200 Coral Sea Streetms Mvs46mounds View, MN 55112 PMA NumberP100010 Supplement NumberS134 Date Received12/21/2022 Decision Date01/19/2023 Product Code OAE Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reaso...
Medtronic CryoCath LP8200 Coral Sea Streetms Mvs46mounds View, MN 55112 PMA NumberP100010 Supplement NumberS135 Date Received12/22/2022 Decision Date01/19/2023 Product Code OAE Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reaso...
Medtronic CryoCath LP8200 Coral Sea Streetmounds View, MN 55112 PMA NumberP020045 Supplement NumberS102 Date Received12/22/2022 Decision Date01/19/2023 Product Code LPB Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Proces...
MEDTRONIC Inc.8200 Coral Sea Street Nems Mv S11mounds View, MN 55112 PMA NumberP980035 Supplement NumberS738 Date Received01/09/2023 Decision Date01/17/2023 Product Code NVZ Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason P...
MEDTRONIC Inc.8200 Coral Sea Street Nems Mv S11mounds View, MN 55112 PMA NumberP010015 Supplement NumberS512 Date Received01/09/2023 Decision Date01/17/2023 Product Code LWP Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason P...
MEDTRONIC Inc.8200 Coral Sea Street Nems Mv S11mounds View, MN 55112 PMA NumberP920015 Supplement NumberS274 Date Received01/09/2023 Decision Date01/16/2023 Product Code NVY Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason P...
Medtronic, Inc.8200 Coral Sea Street N.e.mounds View, MN 55112 PMA NumberP930039 Supplement NumberS248 Date Received01/09/2023 Decision Date01/16/2023 Product Code NVN Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process...
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT8200 Coral Sea Street N.e.mounds View, MN 55112 PMA NumberP830061 Supplement NumberS211 Date Received01/09/2023 Decision Date01/16/2023 Product Code NVN Advisory Committee Cardiovascular Supplement Type30-day Noti...
MEDTRONIC Inc.8200 Coral Sea Street Nems Mv S11mounds View, MN 55112 PMA NumberP980035 Supplement NumberS737 Date Received01/09/2023 Decision Date01/16/2023 Product Code NVZ Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason P...
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT8200 Coral Sea Street N.e.ms Mvs11mounds View, MN 55112 PMA NumberP980016 Supplement NumberS845 Date Received01/06/2023 Decision Date01/13/2023 Product Code LWS Advisory Committee Cardiovascular Supplement Type30-...
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT8200 Coral Sea Street N.e.mounds View, MN 55112 PMA NumberP010031 Supplement NumberS811 Date Received01/06/2023 Decision Date01/13/2023 Product Code NIK Advisory Committee Cardiovascular Supplement Type30-day Noti...
MEDTRONIC Inc.8200 Coral Sea Street Nems Mv S11mounds View, MN 55112 PMA NumberP980035 Supplement NumberS736 Date Received12/15/2022 Decision Date01/04/2023 Product Code NVZ Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason P...
MEDTRONIC MINIMED18000 Devonshire Stnorthridge, CA 91325 PMA NumberP150001 Supplement NumberS102 Date Received11/16/2022 Decision Date12/16/2022 Product Code OZO Advisory Committee Clinical Chemistry Supplement Typespecial (immediate Track) Supplement Reas...
MEDTRONIC MINIMED, INC.18000 Devonshire Streetnorthridge, CA 91325 PMA NumberP160017 Supplement NumberS106 Date Received11/16/2022 Decision Date12/16/2022 Product Code OZP Advisory Committee Clinical Chemistry Supplement Typespecial (immediate Track) Suppl...
MEDTRONIC VASCULAR INC3033 Campus Driveplymouth, MN 55441 PMA NumberP110023 Supplement NumberS036 Date Received11/15/2022 Decision Date12/15/2022 Product Code NIP Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Chan...
MEDTRONIC VASCULAR INC3033 Campus Driveplymouth, MN 55441 PMA NumberP060001 Supplement NumberS035 Date Received11/15/2022 Decision Date12/15/2022 Product Code NIM Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Chan...
MEDTRONIC Inc.8200 Coral Sea Street Nems Mv S11mounds View, MN 55112 PMA NumberP150033 Supplement NumberS164 Date Received12/06/2022 Decision Date12/12/2022 Product Code PNJ Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason P...
MEDTRONIC NEUROMODULATION7000 Central Avenue Nems Rcw225minneapolis, MN 55432 PMA NumberP080025 Supplement NumberS273 Date Received11/23/2022 Decision Date12/08/2022 Product Code QON Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice ...
MEDTRONIC MINIMED18000 Devonshire Stnorthridge, CA 91325 PMA NumberP150001 Supplement NumberS101 Date Received11/04/2022 Decision Date12/08/2022 Product Code OZO Advisory Committee Clinical Chemistry Supplement Type30-day Notice Supplement Reason Process C...
MEDTRONIC Inc.7000 Central Avenue Neminneapolis, MN 55432-3576 PMA NumberP860004 Supplement NumberS403 Date Received11/23/2022 Decision Date12/08/2022 Product Code LKK Advisory Committee General Hospital Supplement Type30-day Notice Supplement Reason Proce...
MEDTRONIC Inc.7000 Central Avenue Neminneapolis, MN 55432-3576 PMA NumberP960009 Supplement NumberS444 Date Received11/23/2022 Decision Date12/08/2022 Product Code MHY Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Chan...
MEDTRONIC NEUROMODULATION7000 Central Avenue Neminneapolis, MN 55432 PMA NumberP840001 Supplement NumberS534 Date Received11/23/2022 Decision Date12/08/2022 Product Code LGW Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Proces...
MEDTRONIC NEUROMODULATION7000 Central Avenue, N.e.minneapolis, MN 55432 PMA NumberP970004 Supplement NumberS378 Date Received11/23/2022 Decision Date12/08/2022 Product Code EZW Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supple...
MEDTRONIC MINIMED18000 Devonshire Streetnorthridge, CA 91325-1219 PMA NumberP160007 Supplement NumberS046 Date Received11/04/2022 Decision Date12/08/2022 Advisory Committee Clinical Chemistry Supplement Type30-day Notice Supplement Reason Process Change - M...
MEDTRONIC Inc.18000 Devonshire Streetnorthridge, CA 91325-1219 PMA NumberP120010 Supplement NumberS142 Date Received11/04/2022 Decision Date12/08/2022 Product Code OZO Advisory Committee Clinical Chemistry Supplement Type30-day Notice Supplement Reason Pro...
MEDTRONIC MINIMED, INC.18000 Devonshire Streetnorthridge, CA 91325 PMA NumberP160017 Supplement NumberS105 Date Received11/04/2022 Decision Date12/08/2022 Advisory Committee Clinical Chemistry Supplement Type30-day Notice Supplement Reason Process Change - ...
Medtronic CryoCath LP8200 Coral Sea Streetms Mvs46mounds View, MN 55112 PMA NumberP100010 Supplement NumberS133 Date Received11/14/2022 Decision Date12/07/2022 Product Code OAE Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reaso...
MEDTRONIC Inc.7000 Central Avenue Neminneapolis, MN 55432-3576 PMA NumberP860004 Supplement NumberS402 Date Received11/07/2022 Decision Date12/02/2022 Product Code LKK Advisory Committee General Hospital Supplement Type30-day Notice Supplement Reason Proce...
Medtronic, Inc.710 Medtronic Parkwayminneapolis,, MN 55432 PMA NumberP130021 Supplement NumberS128 Date Received11/29/2022 Decision Date12/01/2022 Product Code NPT Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Cha...
Medtronic, Inc.710 Medtronic Parkwayminneapolis,, MN 55432 PMA NumberP130021 Supplement NumberS129 Date Received11/30/2022 Decision Date12/01/2022 Product Code NPT Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Cha...
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