FDA.reportPublic FDA data

Synergy Health Westport Ltd

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30101734253002807036Synergy Health Westport Ltd1N2026-01-01Lodge Road Westport Mayo IE Westport

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1487381235556722P040048TRILOGY AB ACETABULAR SYSTEMMRA2006-06-28
1487381292864665K993603WICHITA FUSION NAIL FULLY THREADED SELF-TAPPING SCREWHSB1999-11-19
1487381879819584K993418FIBERED GDC-18 VORTX SHAPE GUGLIELMI DETACHABLE COILHCG2000-01-21
1487381340547944K992025PRECISION OSTEOLOCK FEMORAL STEMS WITH PURE-FIX HA COATINGMEH1999-08-13
1487381922693899K982032OSTEONICS OMNIFIT HA HIP STEM SERIES, OSTEONICS SECUR-FIT HA HIP STEM SERIES, OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMSMEH1998-07-09
1487381924457615K980713FEMORAL AND TIBIAL PLUGS OF INTERAX TOTAL KNEE SYSTEMJWH1998-05-22
1487381618000938K974556OSTEONICS SCORPIO POSTERIOR CRUCIATE RETAINING TOTAL KNEE SYSTEMJWH1998-02-27
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
1487381989216598K971206MERIDIAN ST FEMORAL STEM AND VITALOCK SOLID BACK SHELL W/ PERI-APATITE COATINGLPH1998-02-11
1487381651598021K970200RELIANCE PF FEMORAL STEMSLZO1997-04-09
1487381463247635K963717MILLEX - MP FILTER UNIT (SLMPO25SS/SLMPL25SS)BSN1997-06-10
1487381187900002K963612DURATION STABILIZED UHMWPEJDI1997-06-11
1487381149849113K962800STRYKER UNIVERSAL DRILL ATTACHMENTS & ACCESSORIESHWE1996-09-11
1487381141261601K962152OSTEONICS SCORPIO POSTERIORLY STABILIZED TOTAL KNEE SYSTEMJWH1996-08-14
1487381764136539K955305PCA +15MM MODULAR FEMORAL HEADMEH1996-01-18
1487381478851287K953067HIP FRACTURE STEM FENESTRATION PLUGJDG1995-08-21
1487381710410385K952923INTRAMEDULLARY COMPRESSION ARTHRODESIS (ICA) NAILHSB1995-09-29
1487381899313285K951089SCIMED GATEWAY PLUSDTL1995-05-31
1487381381634164K9442136.2 VITALLIUM ALLOY CANCELLOUS BONE SCREWHWC1994-12-09
1487381818458731K943054OSTEONICS SECURE-FIT AD ACETABULAR COMPONENT SYSTEMLPH1994-10-04
1487381683535195K942900OSTEONICS SECURE-FIT AD-HA ACETABULAR COMPONENT SYSTEMMEH1995-03-15
1487381482672458K940307HOWMEDICA STRAIGHT STEM FEMORAL COMPONENTJDI1995-01-19
1487381562161138K936127HOWMEDICA PREMIUM FEMORAL COMPONENTJDI1994-10-26
1487382005326822K936126HOWMEDICS DRG FEMORAL COMPONENTJDI1994-10-20
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
1487381015314740K930187OSTEONICS(R) ARC DEPOSITIONED FEMORAL COMPONENTSJDI1994-03-03
1487381831327855K926243ANGIOGRAPHIC CATHETERDQO1993-08-16
1487381044908842K925695OMNIFIT ZIRCONIA C-TAPER FEMORAL BEARING HEADLZO1993-04-20
1487381504721809K923011OSTEONICS UNIX UNICOMPARTMENTALHRY1993-11-30
1487381206386555K922525DALL MILES BROAD BONE PLATEHRS1992-09-22
1487381533622712K921640KINEMAX PLUS ALL PLASTIC TIBIAL COMPONENTJWH1992-09-08
1487381213347451K920231OMNIFIT M-HA HIP STEM SERIESKWL1992-06-08
1487381535025897K911585OMNIFIT II EPF HIP STEM SERIESMEH1991-07-01
1487382064985966K902365MODULAR UNIPOLAR SYSTEMKWL1991-01-11
1487381445780584K900438MC2P ACETABULAR COMPONENTJDI1990-04-18
1487381657149599K891454EXETER II TOTAL HIP SYSTEMJDI1989-06-07
1487381837116114K890326HIP FRACTURE STEM SYSTEM - FENESTRATION PLUGLZN1989-02-03
1487381536594504K884410OMNIFIT TOTAL KNEE SERIES III,IV & POST. STAB. FEMJWH1989-01-18
1487381742599986K880188SOUTER STRATHCLYDE TOTAL ELBOW SYSTEMJDB1988-03-01
1487381018443064K871349HOWMEDICA KINEMATIC II MODULAR TIBIAL COMPONENTJWH1987-09-01
1487382024433507K864633VITALLIUM HEX-DRIVE BONE SCREW SYSTEMHWC1986-12-18
1487381349936495K863668OMNIFIT (TM) TOTAL KNEE PROSTHESIS SYSTEMJWH1986-12-19
1487381741190897K862837OMNIFIT TOTAL KNEE PROSTHESIS SYSTEMHSX1986-12-22
1487381492227556K853886P.C.A. UNIVERSAL ACETABULAR COMPONENT SYSTEMJDI1985-11-25
1487381239427984K850352MICRO-STRUC. ACETABULAR COMPON- MC2PJDL1985-04-25
1487382016732845K833991BIPOLAR HIP DEVICEKWY1984-01-30
1487381571333259K831373P.C.A. HIP SYSTEMJDI1983-08-26
1487381858856855K803192HCL ACETABULAR COMPONENTSKWZ1981-01-23
1487381959912414K191633Infyna ChicGBM2019-07-19
1487381639228140K181507PREVENA RESTOR(TM) Incision Management SystemOMP2019-02-15
1487381251776937K163179Onli Intermittent CatheterGBM2017-01-26
1487381923057835K152268VAPRO PLUS POCKET Intermittent CatheterGBM2015-09-09
1487381733067500K143752Total Knee Application (TKA)OLO2015-08-06
1487381872205646K143320Stryker Elite Attachments, Stryker Heavy Duty (HD) AttachmentsHBE2015-04-23
1487381857234590K143085Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use with the Direct Superior ApproachLPH2015-02-09
1487381892626061K142530Partial Knee Application (PKA)OLO2015-09-16
1487381976540280K141521MUSTANG BALLOON DILATATION CATHETER/CHARGER PTA BALLOON DILATATION CATHETERLIT2014-08-21
1487381752992538K141017PREVENA INCISION MANAGEMENT SYSTEM WITH PEEL & DRESSING, PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING,OMP2015-08-20
1487381411866396K133276V.A.C. GRANUFOAM DRESSING, GRANUFOAM THIN DRESSING, GRANUFOAM ROUND DRESSING, GRANUFOAM SILVER DRESSING, WHITEFOAM DRESSOMP2013-11-19
1487381823699388K133137CISNAP CLOSED INCISION SYSTEMOKO2014-02-25
1487382049251691K132741V.A.C. VIA NEGATIVE PRESSURE WOUND THERAPY SYSTEMOMP2013-11-15
1487381445327789K123878PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSINGOMP2013-01-15
1487381568499514K123507KCI NPWT GAUZE DRESSINGOMP2013-04-04
1487382050373356K123452TRACKER-17 MICROCATHER, 150 CM LONG AND 15.0 CM FLEXIBLE DISTAL SHAFT, TRACKER-17 MICROCATHETER, 150 CM LONG AND 7.5 CMDQY2013-01-03
1487381368686410K120850TARGET DETACHABLE COILHCG2012-04-17
1487381445164638K120816INZONE DETACHMENT SYSTEMKRD2012-04-17
1487381012835105K113412TARGET DETACHABLE COILHCG2011-12-13
1487381717242346K112385TRAGET DETACHABLE COILHCG2011-09-15
1487381135118871K103008INZONE DETACHMENT SYSTEMHCG2010-12-10
1487381491257105K102672TARGET DETACHABLE COILHCG2010-10-15
1487381679173689K093644RESTORATION ADM SYSTEM X3 ACETABULARMEH2009-12-18
1487381349375657K093526V.A.C. VIA THERAPY SYSTEM, V.A.C. VIA NEGATIVE PRESSURE THERAPY UNIT, V.A.C. VIA DRESSING (CONTAINING V.A.C. GRANUFOAM DOMP2010-03-10
1487381614033471K093142TARGET DETACHABLE COILS AND INZONE DETACHMENT SYSTEMHCG2010-02-04
1487381037108487K092712SKIN BARRIER FILMKMF2010-02-23
1487381112347750K092561REJUVENATE MODULAR STEMMEH2009-10-20
1487381422329088K092406ABG II MODULAR HIP STEMMEH2009-11-04
1487382026777853K082575ACTIFUSE BONE GRAFT SUBSTITUTE AND ABX E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTESMQV2008-11-25
1487381941083614K082010STRYKER DISPOSABLE CRANIAL PERFORATOR BITHBF2008-12-29
1487381346103059K071082STRYKER MODULAR HIP SYSTEMLZO2007-09-13
1487381609526687K063857SIMPLEX P SPEEDSET WITH TOBRAMYCIN BONE CEMENTMBB2007-02-26
1487381208101385K063740V.A.C. THERAPY SYSTEMS - INFO V.A.C. THERAPY UNIY, MODEL M6257766OMP2007-06-07
1487381753646675K063692V.A.C. THERAPY SYSTEMS-ACTI V.A.C. THERAPY UNIT MODEL# 340000OMP2007-06-07
1487381870784637K063616TRIDENT II ACETABULAR SYSTEMLZO2006-12-20
1487381227541706K062553SIMPLEX P BONE CEMENTLOD2007-01-08
1487381926341193K061434TRIDENT LARGE DIAMETER HIP SYSTEMLPH2006-08-22
1487381699770646K060819COOL.CLICK 2KZE2006-06-16
1487381112455051K060692COMPREHENSIVE PRIMARY SHOULDER STEMSMBF2006-05-30
1487381336734246K060061STRYKER INJECTABLE CEMENTMQV2006-03-01
1487381633075763K060031DEPUY MODULAR M HEADSLPH2006-01-31
1487381944050919K052748SYSTEM 12 X3 ACETABULAR INSERTS; SERIES II X3 ACETABULAR INSERTSJDI2005-12-02
1487381391644364K051363RESTORATION MODULAR SYSTEMJDI2005-06-23
1487381798936660K051223HIPSTAR FEMORAL STEMLZO2006-05-10
1487382062518495K050863IMAGER II ANGIOGRAPHIC CATHETERDQO2005-09-02
1487381006473126K050700MATRIX STRETCH RESISTANT (SR) COILSHCG2005-04-15
1487381765165017K050261V.A.C. GRANUFOAM SILVER PROTECTION DRESSINGOMP2005-05-26
1487381663176515K043374DURACON CONVERSION AND X-SMALL SYMMETRIC PATELLA WITH PERI-APATITE COATINGMBH2005-02-16
1487381750869491K043142INION OTPS BIODEGRADABLE MINI PLATING SYSTEMHWC2005-02-18
1487381025639544K042539GDC-10 360 DEGREE COIL SR; GDC-10 360 DEGREE SOFT COIL SR; GDC-18 360 DEGREE COILHCG2004-10-19
1487381770543256K040964SCORPIO TOTAL KNEE SYSTEM - POSTERIOR STABILIZED TIBIAL INSERTSJWH2004-05-28
1487381834334560K040300STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE)ERL2004-03-03
1487381739992551K033972SCORPIO TOTAL KNEE SYSTEMMBH2004-04-12
1487381842441977K032310MINI V.A.C., V.A.C. FREEDOM, V.A.C. ATSOMP2003-10-10
1487381530802314K032303STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEMHBE2004-01-16
1487381833198119K031049GUGLIELMI DETACHABLE COIL (GDC)HCG2003-08-01
1487381405247978K030475GDC STRETCH RESISTANT DETACHABLE COILHCG2003-03-14
1487381046616909K02207736MM V40 FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT)JDI2002-07-25
1487381187896037K021911TRIDENT CROSSFIRE POLYUETHYLENE LINERSLPH2002-07-02
1487381720137876K020989SUPER EON PLUS FEMORAL STEMSJDI2002-04-26
1487381547429983K020615SUPER SECUR-FIT HA HIP STEMS AND SUPER SECUR-FIT PLUS HA HIP STEMSMEH2002-05-13
1487381605758525K014199SURGICAL SIMPLEX P WITH TOBRAMYCINLOD2003-05-06
1487381313027775K013989ZIRCONIA CERAMIC FEMORAL HEAD - 12/14 TAPERLZO2001-12-19

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JDI142005-12-02
HCG132012-04-17
OMP112019-02-15
JWH112004-05-28
MEH92009-12-18
LPH72015-02-09
LZO72007-09-13
GBM32019-07-19
HWC32005-02-18
OLO22015-09-16
HBE22015-04-23
MQV22008-11-25
LOD22007-01-08
DQO22005-09-02
MBH22005-02-16
BSN22002-04-04
HSB21999-11-19
IKT21997-11-20
LZN21995-05-16
KWL21992-06-08
LIT12014-08-21
OKO12014-02-25
DQY12013-01-03
KRD12012-04-17
KMF12010-02-23
HBF12008-12-29
MBB12007-02-26
MRA 12006-06-28
KZE12006-06-16
MBF12006-05-30
ERL12004-03-03
KIJ11997-09-04
EJS11997-08-18
HWE11996-09-11
JDG11995-08-21
DTL11995-05-31
JDQ11994-08-01
FIB11994-04-21
HRY11993-11-30
HRS11992-09-22