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
30028073103002807310Becky Aldhizer1N2026-01-015960 Heisley Rd Mentor OH US 44060
30028073143002807314Becky 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
30101605273002807040Becky Aldhizer1N2026-01-015960 Heisley Rd Mentor OH US 44060
30101629733002807041Becky Aldhizer1N2026-01-015960 Heisley Rd Mentor OH US 44060
30101734253002807036Becky 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
30382850673038285067Becky Aldhizer1N2026-01-015960 Heisley Road Mentor OH US 44060
80218963001168737Becky Aldhizer1N2020-04-255960 HEISLEY RD. 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
1487381235556722P040048TRILOGY AB ACETABULAR SYSTEMMRA2006-06-28
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
1487381292864665K993603WICHITA FUSION NAIL FULLY THREADED SELF-TAPPING SCREWHSB1999-11-19
1487381879819584K993418FIBERED GDC-18 VORTX SHAPE GUGLIELMI DETACHABLE COILHCG2000-01-21
30001688734458K992767BROWNE PACKAGING AND LABEL STEAM PROCESS INDICATORJOJ2000-01-10
2009001527288524K992611MITEK ROTATOR CUFF QUICKANCHOR PLUSHWC1999-09-22
2009001990111077K992487MITEK MINI QUICKANCHOR PLUSHWC1999-09-21
1487381340547944K992025PRECISION OSTEOLOCK FEMORAL STEMS WITH PURE-FIX HA COATINGMEH1999-08-13
30001399908822K991709BROWNE CIDEX OPA INDICATORJOJ1999-10-08
30001480507512K991418BROWNE MVI ETHYLENE OXIDE INDICATORJOJ1999-06-10
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
1487381922693899K982032OSTEONICS OMNIFIT HA HIP STEM SERIES, OSTEONICS SECUR-FIT HA HIP STEM SERIES, OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMSMEH1998-07-09
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
30001748401695K981054BROWNE GA INDICATOR FOR CIDEX PRODUCTSJOJ1998-12-07
1512311222380250K980942REGENT BIOGEL INDICATOR INNER SURGICAL GLOVEKGO1998-05-11
1487381924457615K980713FEMORAL AND TIBIAL PLUGS OF INTERAX TOTAL KNEE SYSTEMJWH1998-05-22
1526041137144977K980210VARIOUS SURGICAL OR PATIENT DRAPESKKX1998-05-15
1487381618000938K974556OSTEONICS SCORPIO POSTERIOR CRUCIATE RETAINING TOTAL KNEE SYSTEMJWH1998-02-27
2009001123528628K974345MITEK KNOTLESS ANCHORMBI1998-02-13
1474281436359340K974002ETHANOL-SL ASSAY, CATALOGUE NUMBER 240-12DIC1998-04-01
1474281548006281K973899UNIFINE PENTIPSFMI1997-12-04
1487381685489684K973444TECA MYOJECT DISPOSABLE NEEDLE ELECTRODESIKT1997-11-20
1487381174802184K973442TECA DISPOSABLE MONOPOLAR NEEDLE ELECTRODESIKT1997-11-20
1487381142521342K973121INTERAX TOTAL KNEE SYSTEMJWH1997-11-18
1487381820981275K972928KERBOULL CROSSJDI1997-11-03
1487381806174485K972683V-DELTA 450EJS1997-08-18
1487381823184336K972367STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENTKIJ1997-09-04
1487381146822983K972228MERIDIAN TITANIUM FEMORAL STEMSLZO1997-12-05
1512312042889001K971514REGENT BIOGEL DIAGNOSTIC PROCEDURE GLOVELYY1997-10-29
1487381989216598K971206MERIDIAN ST FEMORAL STEM AND VITALOCK SOLID BACK SHELL W/ PERI-APATITE COATINGLPH1998-02-11
1512311702606560K970924REGENT BIOGEL SURGICAL GLOVE, BIOGEL M GLOVEKGO1997-04-01
1523521702606560K970924REGENT BIOGEL SURGICAL GLOVE, BIOGEL M GLOVEKGO1997-04-01
1487381651598021K970200RELIANCE PF FEMORAL STEMSLZO1997-04-09
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
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
1487381463247635K963717MILLEX - MP FILTER UNIT (SLMPO25SS/SLMPL25SS)BSN1997-06-10
1487381187900002K963612DURATION STABILIZED UHMWPEJDI1997-06-11
1487381149849113K962800STRYKER UNIVERSAL DRILL ATTACHMENTS & ACCESSORIESHWE1996-09-11
1474281198861947K962482SCUBA SYSTEMHIH1996-11-01
1512311662033144K962472RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETERFAP1996-08-27
2009001514185495K962233TWIST-OFF SCREWHWC1996-10-03
1487381141261601K962152OSTEONICS SCORPIO POSTERIORLY STABILIZED TOTAL KNEE SYSTEMJWH1996-08-14
1503712009469752K961728MIRUSCONE ABUTMENT SYSTEMNHA1996-07-10
2009001634018448K961234DEPUY ADVANTAGE FIXATION SCREW SYSTEMHWC1996-06-19
2009001067060676K961094MITEK THREADED ANCHOR (MODIFICATION)MBI1996-10-03
1503711526231933K955372BALL ATTACHMENT SYSTEMDZE1996-01-23
1487381764136539K955305PCA +15MM MODULAR FEMORAL HEADMEH1996-01-18
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
1487381478851287K953067HIP FRACTURE STEM FENESTRATION PLUGJDG1995-08-21
1487381710410385K952923INTRAMEDULLARY COMPRESSION ARTHRODESIS (ICA) NAILHSB1995-09-29
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
1487381899313285K951089SCIMED GATEWAY PLUSDTL1995-05-31
2009001000856357K945203MITEK THRADED ANCHOR (MTA)JDR1995-03-06
1487381381634164K9442136.2 VITALLIUM ALLOY CANCELLOUS BONE SCREWHWC1994-12-09
1527661610633362K943728BURNFREE BURNSOOTHE HYDROGELMGQ1994-09-27
1527661461362361K943470BURNFREE BURNSOOTHE HYDROGEL BURN BLOTTSMGQ1994-09-27
1487381818458731K943054OSTEONICS SECURE-FIT AD ACETABULAR COMPONENT SYSTEMLPH1994-10-04
1487381683535195K942900OSTEONICS SECURE-FIT AD-HA ACETABULAR COMPONENT SYSTEMMEH1995-03-15
2009001378884529K940414IODOFLEX PASTEKMF1994-04-28
1487381482672458K940307HOWMEDICA STRAIGHT STEM FEMORAL COMPONENTJDI1995-01-19
1487381562161138K936127HOWMEDICA PREMIUM FEMORAL COMPONENTJDI1994-10-26
1487382005326822K936126HOWMEDICS DRG FEMORAL COMPONENTJDI1994-10-20
1763431024112766K934779AGRAM SPYRAL ELECTRODEGXZ1995-03-14
1487381177590624K934069MILLEX, DUALEX (PLUS, ULTRA)FIB1994-04-21
1487382030808247K934059DALL MILES SYSTEM GROOVED BUTTONJDQ1994-08-01
1487381047886641K933102HOWMEDICA ACETABULAR SHELL W/SCREW HOLESLPH1994-05-16
1487381576589289K933077EXETER INTRAMEDULLARY BONE PLUGLZN1995-05-16
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

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JOJ302019-09-05
MLR202023-10-20
FLE192026-06-24
KGO172019-05-24
JDI172012-03-29
JWH172005-02-18
DZE162018-11-01
LZO152019-07-22
OMP152019-02-15
MQV152018-12-06
HWC152011-04-11
HCG132012-04-17
FGE122007-11-08
NKB112017-01-19
DQY102018-01-04
HRX102015-07-23
FRO92014-05-02
MEH92009-12-18
LPH82017-11-30
MAX82017-11-13
LIT82016-04-25
FMF72014-12-17
MNI72011-11-21
KOD72002-01-14
GBM62019-07-19
LHI62017-10-12
DQX62014-12-19
FTL62011-05-13
GWM62008-06-27
JDR61995-03-06
HSB52018-06-06
LZA52016-08-02
HIH52015-11-13
DQO52012-09-14
HRS42018-04-06
FMI42018-03-21
GEI42016-10-26
DYB42016-07-21
FCG42016-03-21
JXI42016-01-13