29 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ACCOLADE-J HIP STEM SERIES
FDA 510(k)
FDA Class 2
·Orthopedic
Accolade TMZF Plus Hip Stem: Catalog # 3020-0537 Accolate d TMZF Hip Stem # 5 Catalog #6020-3535 Accolade 132 Size 3.5 Catalog # 6021-0230 Accolade Plus TMZF Hip Stem #2 Catalog # 6021-0335 Accolade Plus TMZF Hip Stem #3 Catalog #3021-0435 Accolade TMZF Hip Stem #4 Catalog # 6021-0435 Accolade Plus TMZF Hip Stem #4 Catalog #6021-2530 Accolade (127 deg) Size 2.5 Accolade (127 deg) Size 2.5 Catalog # 6021-4535 Accolade (127 DEG) Size 4.5 K994366; k023105; K032300 Manufactured by " Stryker Ireland, Carrigtwohill Industrial Estate Carrington County Cork, Ireland The subject hip stem is a single-use device intended for the reconstruction of the head and neck of the femoral joint. This hip stem is intended for primary reconstruction of the proximal femur or revision total hip arthroplasty.
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code ISL·March 1, 2011
Per-Q-Cath Plus
FDA UDI
Bard Access Systems, Inc.·00801741074738·PERQCATH 2FR REPAIR KIT
Flex
FDA UDI
Diversified Products, Inc.·00842894158685·
Cosmolock
FDA UDI
Kalitec Direct LLC·B07310K0123000·Recovery Tube, MIS
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04059993024551·ELVAREX 2/BODY BANDAGE WITH LEG EXTENSION/SLIP ...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702319972·ELVAREX 1/THIGH HIGH/SLANT-OPEN TOE/DOTTED SIL....
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04059993019212·ELVAREX 1/BODY BAND WITHOUT LEG EXTENSION/SLIP...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702284027·Elvarex 3/Knee High/Closed Toe-Elephantiasis-Ve...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702264340·Elvarex 2/Knee High/Slant-Open Toe-Elephantiasi...
JOBST Elvarex Soft
FDA UDI
BSN-Jobst GmbH·04059993317264·ELVAREX SOFT 1/KNEE HIGH/SLANT-OPEN TOE-ELEPHAN...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04059993014804·ELVAREX 1/BODY BANDAGE WITH LEG EXTENSION/SLIP ...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702294187·Elvarex 3/Thigh High/Closed Toe-Elephantiasis-V...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04059993015801·E2/BB-WOE/BS-SLIP-WN/FFM/BL
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702549133·Elvarex 4/Thigh High/Profile-Closed Toe/Dotted...
JOBST Elvarex Soft
FDA UDI
BSN-Jobst GmbH·04059993360871·ELVAREX SOFT 2/KNEE HIGH/SLANT-OPEN TOE-ELEPHAN...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702496123·ELVAREX FORTE 3/KNEE HIGH/SLANT-CLOSED TOE/DOTT...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702286427·Elvarex 2/Chap Style/Slant-Closed Toe/outside h...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702328981·Elvarex Forte 3/Thigh High/Open Toe, Knee Comfo...
JOBST Elvarex Soft
FDA UDI
BSN-Jobst GmbH·04059993355631·ELVAREX SOFT 3/KNEE HIGH/SLANT-OPEN TOE-ELEPHAN...