1,593 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HGP II TOTAL HIP FEMERAL STEM
FDA 510(k)
FDA Class 2
·Orthopedic
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810057372636·Hourglass Procedure Table with Leg, Phenolic
TM REVISION SHELL 62MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·June 25, 2020
UNKNOWN STRYKER OMNIFLEX STEM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JDG·December 13, 2017
HARRIS/GALANTE POROUS (HGP) HIP PROSTHESIS WITH CALCICOAT CERAMIC COATING
FDA 510(k)
FDA Class 2
·Orthopedic
ZIMMER, INC.
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code KWB·February 20, 1998
ZIMMER, INC.
FDA Adverse Event
Injury
·ZIMMER, INC.·August 24, 1992
UNKNOWN ZIMMER FEMORAL HEAD
FDA Adverse Event
Injury
·ZIMMER INC·Product code KWZ·December 2, 2015
HGP I CUSTOM LINER
FDA Adverse Event
Malfunction
·ZIMMER·Product code KWA·March 11, 1994
HGP I CUSTOM LINER
FDA Adverse Event
Malfunction
·ZIMMER·Product code KWA·March 11, 1994
SOLCO-TRANS
FDA Adverse Event
SOLCO-BASLE HGP·Product code LWE·March 15, 1993
HGP II
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code HTW·May 27, 2016
HARRIS GALANTE POROUS CUP, 52 MM O.D.
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code MBL·January 14, 1993
HARRIS GALANTE TOTAL HIP ACETABULAR SHELL AND LINER
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JDI·August 29, 2000
ZIMMER
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code KWB·September 5, 2002
Product 33 consists of all product under product code: JDI and same usage: Item no: 662406515 HGP II ACETABULAR CUP BON 662406520 HGP II ACETABULAR CUP BON 662406525 HGP II ACETABULAR CUP BON 662406530 HGP II ACETABULAR CUP BON 662406535 HGP II ACETABULAR CUP BON 662406540 HGP II ACETABULAR CUP BON 662406550 HGP II ACETABULAR CUP BON 662406560 HGP II ACETABULAR CUP BON For use in total hip arthroplasty
FDA Enforcement
Class II
·Terminated·Zimmer Manufacturing B.V.·March 23, 2016
HGP II ACETABULAR COMPONENTS BONE SCREW SELF-TAPPING
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code NDJ·June 20, 2001
Hgp ii acetabular cup bone screw selftap 6.5x15mm 00662406515 Hgp ii acetabular cup bone screw selftap 6.5x20mm 00662406520 Hgp ii acetabular cup bone screw selftap 6.5x25mm 00662406525 Hgp ii acetabular cup bone screw selftap 6.5x35mm 00662406535 Hgp ii acetabular cup bone screw selftap 6.5x55mm 00662406550 Hgp ii acetabular cup bone screw selftap 6.5x60mm 00662406560
FDA Enforcement
Class II
·Terminated·Zimmer Manufacturing B.V.·May 25, 2016
CARPENTIER-EDWARDS PERIMOUNT MAGNA AND MAGNA EASE PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Death
·EDWARDS LIFESCIENCES·Product code DYE·October 4, 2013
Hgp ii acetabular cup bone screw selftap 6.5x15mm 00662406515 Hgp ii acetabular cup bone screw selftap 6.5x20mm 00662406520 Hgp ii acetabular cup bone screw selftap 6.5x25mm 00662406525 Hgp ii acetabular cup bone screw selftap 6.5x35mm 00662406535 Hgp ii acetabular cup bone screw selftap 6.5x55mm 00662406550 Hgp ii acetabular cup bone screw selftap 6.5x60mm 00662406560
FDA Recall
Terminated
·Product code JDI·May 4, 2016