27 results
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20ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Stryker Radius Locking Caps, Catalog Number: 486610000, Manufactured by Stryker Spine SAS Z.I. Marticot - 33610 Cestas France.,Distributed by Howmedica Osteonics Corp. 325 Corporate Drive, Mahway, NJ 07430
FDA Recall
Terminated
·Stryker Spine·Product code NKB·July 10, 2007
Shelf Pack: Bard-Parker Rib-Back Stainless Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417
FDA Recall
Terminated
·Becton Dickinson & Company·Product code GES·August 10, 2007
Shelf Pack: Bard-Parker Rib-Back Carbon Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417
FDA Recall
Terminated
·Becton Dickinson & Company·Product code GES·August 10, 2007
Spectranetics Quick-Cross Support Catheters, .035in x 90cm, REF#: 518-036, Sterile, Manufactured by: Spectranetics, Colorado Springs, Colorado 80907.
FDA Recall
Terminated
·Spectranetics Corporation·Product code DQY·December 10, 2007
Guidewire, 70cm x 1mm, REF 5583705, Sterile, Single Use, BARD Access Systems, Hemodialysis Catheter, Salt Lake City, UT 84116.
FDA Recall
Terminated
·C.R. Bard Access Systems, Inc·Product code MPB·August 10, 2007
Storz Equipment, Fluid Management Stand, for Fluid Management Systems, Product Number 26601EQ-KT
FDA Recall
Terminated
·Karl Storz Endoscopy America Inc 600 Corporate Pointe·Product code HIG·August 17, 2007
Total B-hCG Speciment Diluent is composed of 1 bottle of Total B-hCG Specimen Diluent containing animal serum.
FDA Recall
Terminated
·Abbott Diagnostic International, Ltd. 30 Bo Cruce Davila·Product code JHI·April 10, 2007
Allura Xper FD20 X-Ray System, Release 2.2, Philips Medical Systems, Bothell, WA 98021
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code IZI·September 24, 2007
Allura Xper FD20/10, Release 1.2, Philips Medical Systems, Bothell, WA 98021
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code IZI·September 24, 2007
Boston Scientific-Renegade Hi-Flo Microcatheter Kit, UPN Material Number: MOO1183030,Catalog Number: 18-303
FDA Recall
Terminated
·Boston Scientific Corporation·Product code KRA·September 10, 2007
Gambro cartridge blood tubing set used with Gambro Dasco Phoenix and Cobe Centrysystem 3 (and 3+) Hemodialysis System, Gambro, Lakewood, CO 80401
FDA Recall
Terminated
·Gambro Renal Products, Inc.·Product code KDI·September 10, 2007
IMx Total B-hCG Reagent is composed of one bottle of Anti B-hCG Coated Microparticles, one bottle of Anti B-hCG Alkaline Phosphatase Conjungate, one bottle of 4-Methylumbelliferyl Phosphate and one bottle of Specimen Diluent.
FDA Recall
Terminated
·Abbott Diagnostic International, Ltd. 30 Bo Cruce Davila·Product code JHI·April 10, 2007
Signify hCG Serum/Urine 30 Test Kit, Abbott List No. 07K09-30, ABI List No. 6026KSI, Lot# 84936, Exp 02/10/2007
FDA Recall
Terminated
·Applied Biotech Inc·Product code JHI·May 5, 2006
AxSYM Total B-hCG Reagent List 7A59-22 is composed of one bottle of Anti B-hCG Coated Microparticles, one bottle of Anti- B- hCG Alkaline Phosphatase Conjugate and one bottle of Specimen Diluent. REF 7A59-22. 100 Tests. For In Vitro Diagnostic Use.
FDA Recall
Terminated
·Abbott Diagnostic International, Ltd. 30 Bo Cruce Davila·Product code JHI·April 10, 2007
AxSYM Total B-hCG Reagent List 7A59-21 is composed of one bottle of Anti B-hCG Coated Microparticles, one bottle of Anti- B-hCG Alkaline Phosphatase Conjugate and one bottle of Specimen Diluent. REF 7A59-21. 100 Tests. For In Vitro Diagnostic Use.
FDA Recall
Terminated
·Abbott Diagnostic International, Ltd. 30 Bo Cruce Davila·Product code JHI·April 10, 2007
Siemens, SONOLINE Antares Ultrasound System, 5.0 Systems with software version 200.0.054, P/N 05936518 and 10037593 , Siemens, Ultrasound Division, Mountain View, CA 94039
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc.·Product code IYN·July 10, 2007
Precision 500D Classical R&F System with control room PC; Image-intensified fluoroscopic x-ray system; ; Model Number: 5117866-27.
FDA Recall
Terminated
·GE Healthcare·Product code JAA·August 1, 2007
Siemens, ACUSON Antares, Ultrasound System (Standard and Premium Edition), 5.0 Systems with software version 200.0.054, P/N : 10032747 and 10032746 standard, 10032746, 10037591, and 10038202 for premium edition, Siemens, Ultrasound Division, Mountain View, CA 94039
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc.·Product code IYN·July 10, 2007
Symmetric Total Knee Femoral Components Product Usage: Symmetric Total Knee Femoral Component is intended for use with Signal Medical Corp. Total Knee System for cemented use INA Total Knee Replacement. The femoral component is made of cobalt chromium alloy (ASTM F75).
FDA Enforcement
Class II
·Terminated·Signal Medical Corporation·October 29, 2014
Abbott Clinical Chemistry Aeroset/Architect (c Systems)Bilirubin Calibrator, List Number (LN) 1E66-03 & List Number (LN) 1E66-04, Abbott Laboratories, Abbott Park, IL 60064
FDA Recall
Terminated
·Abbott Laboratories Inc.·Product code JIX·August 10, 2007