Omnilux CLEAR
GlobalMed Technologies
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 8022265 | 3002861325 | GLOBALMED, INC. | 1 | N | 2026-01-01 | 155 N. MURRAY ST. TRENTON Ontario CA K8V5R5 |
| 3004009431 | 3004009431 | GlobalMed Holdings, LLC | 1 | N | 2026-01-01 | 15020 North 74th Street Scottsdale AZ US 85260 |
| 3006053983 | 3006053983 | GLOBALMED LOGISTIX LLC | 1 | Y | 2026-01-01 | 1880 Beaver Ridge Cir Norcross GA US 30071 |
| 3010605677 | 3010605677 | GLOBALMED INTERNATIONAL LTD | 1 | N | 2020-04-25 | 156/157 Connaught Rd, Room 1401 14/F Hong Kong Not Applicable HK - |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 174153 | 2015245349 | P880047 | INTERCEED TC7 ABSORBABLE ADHESION BARRIER | MCN | 1989-09-15 |
| 174153 | 1842402146 | P800002 | AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT NON-WOVEN WEB | LMF | 1980-10-24 |
| 174153 | 1855406652 | K993848 | MILLENNIUM HUBER PLUS SAFETY INFUSION SET | FPA | 2000-01-27 |
| 174153 | 1911059780 | K992257 | NEW MULTIPLES REAGENT STRIPS | JIR | 1999-11-24 |
| 174153 | 1720151814 | K991088 | VACUTAINER BRAND MULTIPLE SAMPLE LUER ADAPTER, BLOOD COLLECTION SETS AND SAFETY-LOK BLOOD COLLECTION, SAFETY BLOOD COLLE | JKA | 1999-05-28 |
| 174153 | 1308266015 | K983266 | FIBREKOR POST SYSTEM | ELR | 1998-11-09 |
| 174153 | 1396730099 | K983184 | MEPILEX | MGP | 1998-10-28 |
| 174153 | 1254111325 | K982461 | GLASIONOMER CEMENT CX PLUS | EMA | 1998-08-24 |
| 174153 | 1843192445 | K974131 | ALERT | EBF | 1997-12-17 |
| 174153 | 1271714356 | K972239 | ELITE H-D VINYL POLYSILOXANE IMPRESSION MATERIALS .PUTTY SOFT/NORMAL SETTING /PUTTY SOFT/FAST SETTING | ELW | 1997-08-01 |
| 174153 | 1008205237 | K970715 | SYSTEM B HEAT SOURCE | EAT | 1997-04-07 |
| 174153 | 1988755445 | K963141 | KUGEL HERNIA PATCH | FTL | 1996-10-11 |
| 174153 | 1036953760 | K962925 | OLYMPUS B-5/B-7 SERIESBALLOON CATHETER | FGE | 1996-10-25 |
| 174153 | 1634176610 | K962714 | PASSY-MUIR LOW-PROFILE TRACHEOSTOMY AND VENTILATOR SPEAKING VALVE; PRODUCT NUMBER PMV 2000 OR PMTSV 2000 | JOH | 1996-10-28 |
| 174153 | 1756639855 | K962542 | AIR MOTOR HANDPIECE TN-102 | EFB | 1996-09-24 |
| 174153 | 2006560413 | K962173 | SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIES | JOH | 1996-10-04 |
| 174153 | 1910910988 | K955836 | VALLEYLAB COATED ELECTRODES | GEI | 1996-02-01 |
| 174153 | 1936914719 | K955382 | 3M MODEL 1860 HEALTH CARE PARTICULATE RESPIRATOR TYPE N95 | FXX | 1996-05-01 |
| 174153 | 1317489015 | K955103 | 3M NO STING BARRIER FILM | KMF | 1996-02-05 |
| 174153 | 1374211073 | K952662 | COMP=FLOW | EBF | 1995-08-28 |
| 174153 | 1399564010 | K952578 | WELCH ALLY OTOSCOPE | ERA | 1995-07-10 |
| 174153 | 2023869967 | K951589 | MANUAL SURGICAL INSRUMENT | GEI | 1995-05-03 |
| 174153 | 1370450928 | K951254 | SAFETYGLIDE NEEDLE | FMI | 1995-10-07 |
| 174153 | 1067198975 | K950300 | BARD FLEXIBLE TIP URETERAL CATHETER | EYB | 1995-04-27 |
| 174153 | 1466928522 | K945244 | PULP CANAL SEALER EWT | EMA | 1994-12-29 |
| 174153 | 1937065396 | K942159 | NOVOPEN 1.5 | FMF | 1995-04-26 |
| 174153 | 1497887277 | K936194 | COAXIAL BIOPSY NEEDLE | FCG | 1994-03-22 |
| 174153 | 1202880064 | K936095 | GAUZE SPONGE | EFQ | 1994-02-02 |
| 174153 | 1547341412 | K935803 | CICA-CARE SILICONE GEL SHEET | MDA | 1994-02-03 |
| 174153 | 1518838494 | K931962 | NON-ABSORBABLE GAUZE | GCJ | 1993-12-10 |
| 174153 | 1949848353 | K922123 | AUTO SUTURE DISPOSABLE ENDOSCOPIC SPECIMEN POUCH | GCI | 1993-02-01 |
| 174153 | 1986402146 | K914190 | AUTO SUTURE(R) ENDOSCOPIC FAN RETRACTOR | GAD | 1992-05-06 |
| 174153 | 1727754109 | K914088 | BIVONA AIRE-CUF(R) PEDIATRIC TRACHEOSTOMY TUBE | JOH | 1991-10-23 |
| 174153 | 1982125997 | K912520 | 3M WATER DISPERSIBLE ADHESIVE TAPE, 98XX | KGX | 1991-07-26 |
| 174153 | 1068565876 | K912469 | BIVONA WIRE REINFORCED PEDIATRIC TRACHEOSTOMY TUBE | BTO | 1991-06-19 |
| 174153 | 1353689674 | K904779 | BUTTON REPLACEMENT GASTROSTOMY DEVICE | KGC | 1991-01-18 |
| 174153 | 1043530430 | K903699 | PASSY-MUIR TRACHEOSTOMY SPEAKING VALVE 15MM / 22MM | JOH | 1990-09-04 |
| 174153 | 1500921799 | K903207 | AUTO SUTURE ENDOSCOPIC SUCTION/IRRIGATRION DEVICE | HET | 1990-09-25 |
| 174153 | 1657207223 | K873525 | DEKNATEL TROCAR CATHETER | JOL | 1987-11-02 |
| 174153 | 1854355779 | K870866 | THE GRIPPER(TM) PORT-A-CATH NEEDLES | FPA | 1987-06-25 |
| 174153 | 1104106429 | K863330 | DISPOSABLE PNEUMOPERITONEUM NEEDLE | FHO | 1986-10-02 |
| 174153 | 1487272422 | K861005 | GLASIONOMER BASE CEMENT | EMA | 1986-04-25 |
| 174153 | 1531310789 | K854347 | HYBRID POINTS | DZP | 1985-12-27 |
| 174153 | 2052006688 | K851840 | STOMAHESIVE SKIN BARRIER STERILE | EXB | 1985-06-24 |
| 174153 | 1670113609 | K851477 | VYGON EXCHANGE TRANSFUSION TRAY 275.00 | BRZ | 1985-05-03 |
| 174153 | 1087443961 | K843844 | CO2 TEST | CCK | 1984-10-12 |
| 174153 | 1220624750 | K840166 | SUR-FIT UROSTOMY POUCH W/ACCUSEAL | EXB | 1984-02-04 |
| 174153 | 1770563441 | K831229 | SUPER SNAPS | FHJ | 1983-05-09 |
| 174153 | 1990369199 | K830199 | AUTO SUTURE TA DISPOS-STAPLE CART | GDW | 1983-04-12 |
| 174153 | 1319968512 | K823879 | COVER-ROLL STRETCH | NAB | 1983-03-09 |
| 174153 | 1900049145 | K820409 | ELECTRONIC CLINICAL THERMOMETER TEMP PR | FLL | 1982-03-02 |
| 174153 | 1001240726 | K813265 | 3M STERI-STRIP ANTIMICROBIAL SKIN CLOS | KGX | 1983-02-09 |
| 174153 | 1156604304 | K811820 | BIPOLAR COAGULATING FORCEPS | GEI | 1981-07-28 |
| 174153 | 1964191278 | K811447 | SHILEY DISPOSABLE CANNULA TRACH. TUBE | BTO | 1981-06-26 |
| 174153 | 1534982438 | K802611 | AUTO SUTURE DISPOS., EEA SURG. STAPLER | GAG | 1980-11-12 |
| 174153 | 1371416870 | K801794 | ELASTIC ADHESIVE BANDAGES(STERILE) | KGX | 1980-08-13 |
| 174153 | 1431506521 | K801504 | HOLLISTER DRAINAGE POUCH | FON | 1980-08-12 |
| 174153 | 1267334096 | K791819 | AIR INCENTIVE SPIROMETER | BWF | 1979-09-26 |
| 174153 | 1020738246 | K771864 | WALL TRANSFORMERS 74710 & 74910 | GCW | 1977-11-22 |
| 174153 | 1405785440 | K771045 | BLADES, SCALPEL | GES | 1977-06-22 |
| 174153 | 1242596197 | K760125 | AIRWAY, ARGYLE NASOPHARYNGEAL | BTQ | 1976-07-19 |
| 182594 | 1291720325 | K233245 | MagnetOs Flex Matrix | MQV | 2023-11-21 |
| 182594 | 1164310948 | K213959 | MagnetOs Flex Matrix | MQV | 2022-04-14 |
| 121784 | 1243028242 | K181658 | MobileECG 2 BT | DSI | 2019-03-26 |
| 174153 | 1141473085 | K180646 | Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs | LZC | 2018-06-27 |
| 174153 | 1990752953 | K173437 | 3M Attest Super Rapid Readout Biological Indicator 1492V, 3M Attest Auto-reader 490, 3M Attest Auto-reader 490H | FRC | 2018-03-19 |
| 121784 | 1238889695 | K170047 | All-in-One Health Monitor, PC-303 | MWI | 2017-09-09 |
| 174153 | 1843609655 | K162432 | Multi-Link X2 ECG Cable and Lead Wire System | DSA | 2017-01-18 |
| 174153 | 1845646558 | K161215 | Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] Tested For Use With Chemotherapy Drugs | LZA | 2016-12-21 |
| 174153 | 1424451138 | K160709 | HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves | LZC | 2016-09-06 |
| 174153 | 1700276550 | K160521 | ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear Cutter, 280mm | GDW | 2016-03-22 |
| 174153 | 1681392497 | K152956 | Pulp Canal Sealer, Pulp Canal Sealer EWT | KIF | 2016-05-06 |
| 174153 | 1150336609 | K152748 | Braun Thermoscan PRO 6000 Ear Thermometer | FLL | 2016-03-01 |
| 174153 | 1610132323 | K152149 | VersaOne Bladed Trocar 5mm | GCJ | 2016-01-22 |
| 174153 | 1402466599 | K151698 | BD Angiocath IV Catheter, BD Insyte IV Catheter | FOZ | 2015-07-27 |
| 174153 | 1216323158 | K151437 | ProLite Mesh, ProLite Ultra Mesh, ProLoop Mesh Plug | FTL | 2015-08-27 |
| 174153 | 1717655101 | K151345 | BioGuard Air/Water Valve, BioGuard Suction Valve | ODC | 2015-08-25 |
| 174153 | 1396105251 | K150844 | Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula, Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Reusable Inner Cannula | JOH | 2015-07-14 |
| 174153 | 1077166349 | K143506 | BIS STANDARD SENSOR,1-CHANNEL (3 ELECTRODES); BIS PEDI SENSOR,1-CHANNEL,3 ELECTRODES; BIS QUATRO SENSOR; BIS PEDI-XP SENSOR,2-CHANNEL (4 ELECTRODES); BIS EXTEND SENSOR; BIS BILATERAL SENSOR,4-CHANNEL (6 ELECRODES); BIS INSIGHT SENSOR,CVI-ENABLED,2-CHANNEL (4 ELECTRODES) | GXY | 2015-04-16 |
| 174153 | 1939166277 | K143287 | Fluidshield* Surgical Mask with Expanded Chamber | FXX | 2015-03-24 |
| 182594 | 1889736811 | K142682 | The Lipogems System | MUU | 2014-12-22 |
| 174153 | 1959878049 | K140685 | ENDO VAC APICAL NEGATIVE PRESSURE IRIGATION SYSTEM | NYL | 2014-07-02 |
| 174153 | 1111996139 | K133948 | BARD(R) MONOPTY(R) DISPOSABLE CORE BIOPSY INSTRUMENT, BARD(R) MAX-CORE(R) DISPOSABLE CORE INSTRUMENT | KNW | 2014-02-21 |
| 121784 | 2064379140 | K133509 | EASY PLUS II BLOOD GLUCOSE MONITORING SYSTEM,EASY PLUS II MULTI BLOOD GLUCOSE MONITORING SYSTEM,SMARTEST PERSONA II BLOO | NBW | 2014-02-21 |
| 174153 | 1332127553 | K132141 | BEAUTIFIL BULK FLOWABLE | EBF | 2013-10-03 |
| 174153 | 1954415364 | K131358 | BD PEN NEEDLE | FMI | 2013-07-16 |
| 121784 | 1627426149 | K131338 | DERMA HOOD | PEQ | 2013-07-10 |
| 174153 | 1290985256 | K130867 | ENFLOW IV FLUID WARMER INSULATED STRAP | LGZ | 2013-06-14 |
| 174153 | 1638322028 | K130653 | ECHELON FLEX 45 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTER; ECHELON FLEX 60 POWERED ARTICULATING ENDOSCOPIC LINEAR CU | GDW | 2013-03-29 |
| 121784 | 1182129945 | K130624 | CONI | LLZ | 2013-05-07 |
| 174153 | 1669583564 | K123601 | SINGLE USE REPOSITIONABLE CLIP | PKL | 2013-04-29 |
| 174153 | 1586104690 | K123033 | ROCKET IPC INSERTION PACK, ROCKET IPC MINI INSERTION SET, ROCKET IPC DRESSING PACK AND BOTTLE SET, ROCKET IPC DRAINAGE B | DWM | 2013-02-01 |
| 174153 | 1369105490 | K122908 | PRG BARRIER COAT | LBH | 2013-04-26 |
| 174153 | 1317177630 | K121275 | AQUACEL AG EXTRA HYDROFIBER DRESSING WITH SILVER AND STRENGTHENING FIBER | FRO | 2012-07-25 |
| 174153 | 1718516169 | K120743 | SPECULUM, VAGINAL, NONMETAL | HIB | 2012-03-23 |
| 174153 | 1027030499 | K120037 | BLUWHITE DIAMOND DENTAL BURS MODIFIED | DZP | 2012-04-20 |
| 174153 | 1501289833 | K111933 | COVIDIEN NELLCOR RESPIRATION RATE SOFTWARE APPLICATION, VERSION 1.0 | BZQ | 2012-03-15 |
| 174153 | 1713163938 | K111825 | ENDO GIA(TM) STAPLERS, DST SERIES(TM) GIA(TM) STAPLERS, DST SERIES(TM) TA(TM) STAPLERS | GDW | 2011-10-25 |
| 121784 | 1876195378 | K111463 | VALEO VT-601 SERIES IR THERMOMETER | FLL | 2012-02-17 |
| 174153 | 1955036683 | K111402 | KC200, SURGICAL MASK, KC200, PROCEDURE MASK, KC300, SURGICALMASK, FLUIDSHIELD, KC300, PROCEDURE MASK, FLUIDSHIELD MODEL | FXX | 2011-10-20 |
| 174153 | 1164712459 | K103800 | BRAUN THERMOSCAN PRO 4000 SERIES AND BRAUN THERMOSCAN IRT 4000 SERIES CLINICAL INFRARED EAR THERMOMETERS | FLL | 2011-01-26 |
| 174153 | 2057910198 | K103150 | KIMBERLY-CLARK CHILD/PEDIATRIC FACE MASK | OXZ | 2011-09-23 |
| 174153 | 1107893148 | K101249 | STERIGAGE MODEL 1243RA, 1243RB, 1243RE | JOJ | 2010-09-08 |
| 174153 | 1377773108 | K100275 | WORKING ELEMENT, RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATON, HF-RESECTION ELECTRODE LOOPS AND BANDS | FAS | 2010-07-01 |
| 174153 | 1183491997 | K100163 | NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX | FPD | 2011-10-13 |
| 174153 | 1946076036 | K100005 | BD PEN NEEDLE | FMI | 2010-04-15 |
| 174153 | 1202649771 | K093845 | ETHICON SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE, MODEL STRAP25 | GDW | 2010-04-07 |
| 174153 | 1813327742 | K093199 | 3M COMPLY BOWIE- DICK TYPE LEAD FREE TEST PACK | JOJ | 2009-12-04 |
| 174153 | 1285867751 | K091512 | BUILD-IT LIGHT CURE | EBF | 2009-10-30 |
| 174153 | 1474431295 | K090569 | MODIFICATION TO: ATTEST RAPID READOUT BIOLOGICAL INDICATOR, MODE 1292 | FRC | 2009-04-29 |
| 174153 | 1230900029 | K083781 | EEA HEMORRHOID STAPLER & ACCESSORIES | GDW | 2009-02-04 |
| 174153 | 1246207535 | K081089 | KIMBERLY-CLARK STERLING NITRILE & NITRILE-XTRA POWDER-FREE EXAM GLOVES WITH CHEMOTHERAPY DRUG USE CLAIM | LZC | 2008-07-14 |
| 174153 | 1406809037 | K081086 | PORTEX BLUE LINE SACETT SUCTION ABOVE THE CUFF TRACHEAL TUBE, SIZE 6.0 AND 6.5, 7.0 AND 7.5, 8.0 AND 8.5, 9.0 | BTR | 2008-08-13 |
| 121784 | 1137154082 | K081032 | TR-USB TELEPHONIC STETHOSCOPE | DQD | 2008-06-06 |
| 174153 | 1152742079 | K071106 | ENDOREZ OBTURATION KIT (WITH ACCELERATOR), MODEL 403, ENDOREZ ACCELERATOR (REFILL), MODEL 399 | KIF | 2007-05-08 |
| 121784 | 1806539713 | K070907 | INTERSON USB ULTRASOUND PROBE SYSTEM | IYO | 2007-04-17 |
| 174153 | 1980368511 | K070887 | ENDOPATH LINEAR CUTTERS AND STAPLERS AND ECHELON60 ENDOSCOPIC LINEAR CUTTERS AND STAPLERS (AND RELOADS) | GDW | 2007-05-25 |
| 174153 | 1777765214 | K070060 | WELCH ALLYN FLEXIPORT DISPOSABLE BLOOD PRESSURE CUFF (ONE-PIECE); REUSABLE BLOOD PRESSURE CUFF (ONE-PIECE) | DXQ | 2007-12-18 |
| 121784 | 1257356798 | K063641 | PC-60, NON-INVASIVEPULSE OXIMETER | DQA | 2007-07-13 |
| 174153 | 1110868354 | K061554 | MEPILEX AG ABSORBENT SILICONE-COATED DRESSING | FRO | 2007-01-25 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| GDW | 8 | 2016-03-22 |
| JOH | 6 | 2015-07-14 |
| FLL | 5 | 2016-03-01 |
| EBF | 5 | 2013-10-03 |
| FMI | 5 | 2013-07-16 |
| EMA | 5 | 2006-02-03 |
| GCJ | 4 | 2016-01-22 |
| CAH | 4 | 2004-04-26 |
| LZC | 3 | 2018-06-27 |
| FXX | 3 | 2015-03-24 |
| FPA | 3 | 2002-04-16 |
| GEI | 3 | 1996-02-01 |
| KGX | 3 | 1991-07-26 |
| MQV | 2 | 2023-11-21 |
| FRC | 2 | 2018-03-19 |
| KIF | 2 | 2016-05-06 |
| FTL | 2 | 2015-08-27 |
| NBW | 2 | 2014-02-21 |
| LGZ | 2 | 2013-06-14 |
| FRO | 2 | 2012-07-25 |
| DZP | 2 | 2012-04-20 |
| FPD | 2 | 2011-10-13 |
| JOJ | 2 | 2010-09-08 |
| DQD | 2 | 2008-06-06 |
| MDA | 2 | 2001-01-29 |
| ELW | 2 | 2000-07-05 |
| BTO | 2 | 1991-06-19 |
| EXB | 2 | 1985-06-24 |
| DSI | 1 | 2019-03-26 |
| MWI | 1 | 2017-09-09 |
| DSA | 1 | 2017-01-18 |
| LZA | 1 | 2016-12-21 |
| ODC | 1 | 2015-08-25 |
| FOZ | 1 | 2015-07-27 |
| GXY | 1 | 2015-04-16 |
| MUU | 1 | 2014-12-22 |
| NYL | 1 | 2014-07-02 |
| KNW | 1 | 2014-02-21 |
| PEQ | 1 | 2013-07-10 |
| LLZ | 1 | 2013-05-07 |
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