FDA.reportPublic FDA data

Becky Aldhizer

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
80437923002808269Becky Aldhizer1N2026-01-015960 Heisley Road Mentor OH US 44060
96801433002807308Becky Aldhizer1N2026-01-015960 Heisley Rd Mentor OH US 44060
30028064703002806470Becky Aldhizer1N2026-01-015960 Heisley Rd Mentor OH US 44060
30028066033002806603Becky Aldhizer1N2026-01-015960 Heisley Rd Mentor OH US 44060
30028073103002807310Becky Aldhizer1N2026-01-015960 Heisley Rd Mentor OH US 44060
30028073143002807314Becky Aldhizer1N2026-01-015960 Heisley Rd Mentor OH US 44060
30047845373004784537Becky Aldhizer1N2026-01-015960 Heisley Rd Mentor OH US 44060
30058997643005899764Becky Aldhizer1N2026-01-015960 Heisley Rd Mentor OH US 44060
30081020423002924544Becky Aldhizer1N2026-01-015960 Heisley Road Mentor OH US 44060
30082524863008252486Becky Aldhizer1N2026-01-015960 Heisley Road Mentor OH US 44060
30093374013009337401Becky Aldhizer1N2026-01-015960 Heisley Rd Mentor OH US 44060
30097563273002807038Becky Aldhizer1N2026-01-015960 Heisley Rd Mentor OH US 44060
30101556483010155648Becky Aldhizer1N2026-01-015960 Heisley Rd Mentor OH US 44060
30101556613010155661Becky Aldhizer1N2026-01-015960 Heisley Rd Mentor OH US 44060
30101605273002807040Becky Aldhizer1N2026-01-015960 Heisley Rd Mentor OH US 44060
30101629733002807041Becky Aldhizer1N2026-01-015960 Heisley Rd Mentor OH US 44060
30102205953010220595Becky Aldhizer1N2026-01-015960 Heisley Rd Mentor OH US 44060
30102738673010273867Becky Aldhizer1N2026-01-015960 Heisley Rd Mentor OH US 44060
30102738723010273872Becky Aldhizer1N2026-01-015960 Heisley Road Mentor OH US 44060
30102876853010287685Becky Aldhizer1N2026-01-015960 Heisley Rd Mentor OH US 44060
30119266423011926642Becky Aldhizer1N2026-01-015960 Heisley Road Mentor OH US 44060
30133007663013300766Becky Aldhizer1N2026-01-015960 Heisley Road Mentor OH US 44060
30176163933017616393Becky Aldhizer1N2026-01-015960 Heisley Road Mentor OH US 44060
30183132803018313280Becky Aldhizer1N2026-01-015960 Heisley Rd Mentor OH US 44060
30209763543020976354Becky Aldhizer1N2026-01-015960 Heisley Road Mentor OH US 44060

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1487361400424144P990020ANEURX STENT GRAFT SYSTEMMIH1999-09-28
1526042032662275P990004SURGIFOAM ABSORBABLE GELATIN SPONGE, USPLMF1999-09-30
1487361072442751P970020MULTI-LINK ULTRA/ ZETA CORONARY STENT SYSTEMSMAF1997-10-02
29991782696544P960024
29991510808774P880079
29991599784735P850055
29991526483575P820040
1487361984478457P160030Freestyle Libre Flash Glucose Monitoring SystemPZE2017-09-27
1487361059435077P150021FREESTYLE LIBRE PRO FLASH GLUCOSE MONITORING SYSTEMMDS2016-09-23
1487361709953637P110011ASSURANT COBALT ILIAC BALLOON-EXPANDABLE STENT SYSTEMNIO2011-10-26
1523592008259403P100023ION PACLITAXEL- ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE SYSTEMS)NIQ2011-04-22
1487362019214116P090006COMPLETE SE VASCULAR STENT SYSTEMNIO2010-03-17
1487361349887898P070027THE TALENT ABDOMINAL STENT GRAFT SYSTEMMIH2008-04-15
1487361575857991P070015XIENCE AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMSNIQ2008-07-02
1487361093963874P070007TALENT THORACIC STENT GRAFT SYSTEMMIH2008-06-05
1487361072802808P060033ENDEAVOR ZOTAROLIMUS ELUTING CORONARY STENT SYSTEMNIQ2008-02-01
1487361006715873P060003AXSYM, AUSABLOM2006-08-07
1523591244910583P040016VERIFLEX (LIBERTE) BARE-METAL CORONARY STENT SYSTEMMAF2005-04-12
1487361128856568P020047MULTI-LINK VISION/MINI/8 CORONARY STENT SYSTEMSMAF2003-07-16
1523591937668089P020009EXPRESS/EXPRESS 2 MR & OTW CORONARY STENT SYSTEMSMAF2002-09-11
2009001893289071P000025COMBI 40+ COCHLEAR IMPLANT SYSTEMMCM2001-08-20
1474281887183304K994152THE LIGAMENT ANCHOR SOFT SCREWHWC2000-03-06
1474281137024546K993749GYRUS HYSTEROSCOPIC RESECTOSCOPEHIH1999-12-03
2009001527288524K992611MITEK ROTATOR CUFF QUICKANCHOR PLUSHWC1999-09-22
2009001990111077K992487MITEK MINI QUICKANCHOR PLUSHWC1999-09-21
29992013694999K991403SOLO-CARE BRAND MULTI-PURPOSE SOLUTIONLPN1999-07-16
1487361193158581K990130WILSON-COOK PANCREATIC WEDGE STENTFGE1999-02-12
2009001217653540K983818MITEK FASTIN RC ANCHORMBI1998-11-23
1487361897552708K983404TYPE 3 FEMORAL COMPONENTSLZO1998-12-22
2349231690172301K982957SENSIFLEX POWDERFREE SURGEON'S GLOVEKGO1999-01-13
1474281260924400K982771GYRUS HYSTEROSCOPIC RESECTOSCOPEHIH1999-01-21
1474281030746414K982738VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA)HIH1999-03-01
1487361092383703K982083ACS HI-TORQUE BALANCE HEAVYWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATINGDQX1998-09-11
1512311437999963K981535FOCUS PILOT CONTOURING WORKSTATIONIYE1999-04-02
1512311458552817K981534VIPERCAMEIA1998-07-23
1512312049401303K981533AVIVA SYSTEMS MODEL NUMBERS 1010, 2020DRG1998-07-15
1512311692071967K981532LYPHOCHEK IMMUNOASSAY PLUS CONTROLJJY1998-05-12
1512311471678060K981531SUTURE PLACEMENT DEVICE AND ACCESSORIESGCJ1998-07-13
1512311755793726K981530SPACELABS MEDICAL 90519 ANESTHESIA DELIVERY SYSTEMBSZ1998-11-20
2009001222643917K981251KYPHON INFLATABLE BONE TAMPHRX1998-07-02
1512311222380250K980942REGENT BIOGEL INDICATOR INNER SURGICAL GLOVEKGO1998-05-11
1526041137144977K980210VARIOUS SURGICAL OR PATIENT DRAPESKKX1998-05-15
2009001123528628K974345MITEK KNOTLESS ANCHORMBI1998-02-13
1474281436359340K974002ETHANOL-SL ASSAY, CATALOGUE NUMBER 240-12DIC1998-04-01
1474281548006281K973899UNIFINE PENTIPSFMI1997-12-04
1512312042889001K971514REGENT BIOGEL DIAGNOSTIC PROCEDURE GLOVELYY1997-10-29
1512311702606560K970924REGENT BIOGEL SURGICAL GLOVE, BIOGEL M GLOVEKGO1997-04-01
1523521702606560K970924REGENT BIOGEL SURGICAL GLOVE, BIOGEL M GLOVEKGO1997-04-01
1503711566983083K970073BIO-ESTHETIC INDIRECT ABUTMENTNHA1997-07-03
1512311253264797K965016ISO-GARD FILTER ANGLED(18212)/ISO-GARD FILTER STRAIGHT(19212)CAH1997-12-02
1512311784650655K964575SYMPACATH HYDROGEL COATED FOLEYEZL1997-02-04
1474331210343554K964425A-V IMPULSE SYSTEM MODEL 6060JOW1997-07-28
1512311330127308K964382HUMID-VENT FILTER COMPACT ANGLED (18402)/HUMID-VENT FILTER COMPACT STRAIGHT(19402)CAH1997-04-15
2801151729015623K964332EAGLE CENTURY STEAM STERILIZERFLE1998-06-01
2009001618765787K963940EXETER MESHJDJ1997-02-13
1512311572463312K963779RUSCH ENTERAL FEEDING TUBEFPD1997-05-23
1487361463247635K963717MILLEX - MP FILTER UNIT (SLMPO25SS/SLMPL25SS)BSN1997-06-10
1474281198861947K962482SCUBA SYSTEMHIH1996-11-01
1512311662033144K962472RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETERFAP1996-08-27
2009001514185495K962233TWIST-OFF SCREWHWC1996-10-03
1503712009469752K961728MIRUSCONE ABUTMENT SYSTEMNHA1996-07-10
1474331575087330K961512PERKINS HAND-HELD APPLANATION TONOMETERHKY1996-07-18
2009001634018448K961234DEPUY ADVANTAGE FIXATION SCREW SYSTEMHWC1996-06-19
2009001067060676K961094MITEK THREADED ANCHOR (MODIFICATION)MBI1996-10-03
1503711526231933K955372BALL ATTACHMENT SYSTEMDZE1996-01-23
1512311830764283K954828ISO-GARD HEPA FILTER-HME, ISO-ARD HEPA FILTER-HME W/PORTCAH1996-05-02
1512311538395682K954752PEDIATRIC EUROPHYLIC FOLEY CATHETEREZL1995-10-30
2009001884976665K954465FMS DUOHRX1995-11-09
1512311569988415K953963RUSCH SINGLE LUMEN BRONCHIAL TUVBE SET, STERILE, FOR LEFT & RIGHT SIDED BRONCHIAL INTUBATIONBTS1995-11-27
1512311403895690K953590COMFITLYY1996-06-27
1512312020565317K952187RUSCH SUPRAFLEX SUPRAPUBIC CYSTOSTOMY CATHETER KIT, STERILEKOB1995-07-25
1512311017418126K952084HUMID-VENT FILTER PEDIBYD1995-06-12
1512311887902460K951260URINARY INTERMITTENT CATHETERS W/O HYDROMER HYDROPHILIC LUBRICANTKOD1995-09-27
1512311207015672K951091RUSCH ENDOBRONCHIAL TUBE SETSBTS1995-06-08
2009001000856357K945203MITEK THRADED ANCHOR (MTA)JDR1995-03-06
1527661610633362K943728BURNFREE BURNSOOTHE HYDROGELMGQ1994-09-27
1527661461362361K943470BURNFREE BURNSOOTHE HYDROGEL BURN BLOTTSMGQ1994-09-27
2009001378884529K940414IODOFLEX PASTEKMF1994-04-28
1474331544494818K935665INTRAUTERINE SOUNDHHM1994-02-24
1763431024112766K934779AGRAM SPYRAL ELECTRODEGXZ1995-03-14
1764551024112766K934779AGRAM SPYRAL ELECTRODEGXZ1995-03-14
1523521414872220K932074MEDISYSTEMS APHERESIS NEEDLE WITH GUARDFIE1994-02-18
1474281806376079K931960NUFFIELD TOTAL KNEEJWH1994-10-07
2801152012040278K931872THE EAGLE 3017 100% ETHYLENE OXIDE STERILIZERFLF1994-02-07
2009001117199162K931155STAPLE, FIXATION BONE; SCREW FIXATION BONEHWC1994-09-01
2009001319756494K930893MITEK SUPER QUICKANCHOR, MODIFICATIONJDR1993-12-08
2009001133639152K930892MITEK MINI ANCHOR, MODIFICATIONJDR1994-01-07
1474311885786697K930339REAMER BITHTW1993-08-06
1512311798931394K925030SURGEON'S GLOVEKGO1993-07-13
2009001901998613K921873QUICKANCHOR, MODIFICATIONJDR1992-06-09
1527662046154533K921471BURNSHIELD TRAUMA DRESSINGFPY1993-04-20
1527661982984615K921470BURNSHIELD FIRE BLANKETFPY1993-04-20
2009001935115058K915889MITEK BONE ANCHOR, MODIFICATIONJDR1992-10-22
2009001150961949K915081MITEK SNAP PAK(TM), MODIFICATIONGAS1992-01-31
1487361498332553K911605TRACKER UNIBODY, UNIBODY W/SIDE & 25 SIDE HOLESDQO1991-07-09
1503711868972300K911592STERI-OSS TITANIUM PLAMA SPRAY CYLINDRICAL IMPLANTDZE1993-07-22
2009001550774992K910938CODMAN EXTERNAL DRAINAGE SYSTEM II (EDS II)JXG1991-08-16
2009001611883798K905069IODOSORB GELKOZ1991-01-31
1487362066468209K904275MORSE BALLOON INFLATION DEVICEMAV1991-01-03
1512311983175136K903777WRP FOLEYCATHEZL1990-12-13
2009001974023430K902751MITEK ANCHOR IIJDR1990-07-24
1487361308652728K900923ZIMMON ENDOSCOPIC PANCREATIC STENTFGE1990-10-26
1512311468007605K900590BIOSEARCH DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDINGKNT1990-08-02
1487361896409776K900035WILSON-COOK COLON DECOMPRESSION SETFEG1990-03-07
1523522029477442K894360MODEL 280 INFUSION PUMPFRN1989-10-04
1487361618837254K883179HIP FRACTURE STEM SYSTEMKWL1988-09-22
1526041841019863K882724MICROTEK PROBE DRAPEKKX1988-08-03
1512311427750113K874517PHARMASEAL RUBBER URETHRAL CATHETERKOD1987-12-03
1474281635666970K871571NEUROTIPS(TM)GXB1987-06-18
1487362028189842K851962ZIMMON BILIARY STENT SETFGE1985-12-17
1481931226489623K851524SEPTOJECT STERILE DISPOSABLE INJECTION NEEDLEDZM1985-09-23
1474281109592520K851422S-ROM 135 FEMORAL STEM & COLLAR(PART OF S-ROM HIPJDI1985-09-18
1512311510235191K841544AMER. PHARMASEAL SILICONIZED LATEXKOD1984-07-09
1512311256640346K841035ULTRA BAKER JEJUNOSTOMY TUBEKNT1984-04-13
1474331855091167K801221THORA-DRAIN III PLASTIC DRAINAGE SYSTEMKDQ1980-06-09
1512311606742441K770256CATHETERS, SILICONE COATEDKOD1977-02-17
2801151586560591K233065V-PRO maX 2 Low Temperature Sterilization SystemMLR2023-10-20
2801151212555944K232485AMSCO 600 Steam SterilizerFLE2023-09-13
2801151842019977K223476V-PRO maX 2 Low Temperature Sterilization SystemMLR2023-08-07
2801151618118842K222849AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer DisinfectorNVE2022-09-30

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MLR202023-10-20
FLE182023-09-13
KGO172019-05-24
DZE162018-11-01
MQV132018-12-06
FGE132007-11-08
HWC122011-04-11
NKB112017-01-19
FRO112014-05-02
HRX102015-07-23
DQY92018-01-04
MAX92017-11-13
LZO82019-07-22
LIT82016-04-25
FMF82014-12-17
FTL82011-05-13
MNI72011-11-21
KOD72002-01-14
LHI62017-10-12
DQX62014-12-19
GWM62008-06-27
JWH62005-02-18
JDR61995-03-06
LZA52016-08-02
DYB52016-07-21
HIH52015-11-13
FMI42018-03-21
GEI42016-10-26
FCG42016-03-21
JXI42016-01-13
MNH42015-03-25
NDN42015-03-06
BTR42014-11-24
OMP42010-09-17
NHA42007-07-11
LPN42005-08-10
HSB32018-06-06
HRS32018-04-06
NPL32017-10-30
JAQ32017-01-27