37 results · 18ms · Sources: EU EUDAMED, US FDA

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smith&nephew BHR SQUARE HEADED NAIL, REF CATALOG NUMBER 999908. For use during orthopedic surgery.

FDA Enforcement
Class II ·Terminated·Smith & Nephew Orthopaedics Ltd. (Aurora)·August 18, 2021

smith&nephew BHR SQUARE HEADED NAIL, REF CATALOG NUMBER 999908. For use during orthopedic surgery.

FDA Recall
Terminated ·Smith & Nephew Orthopaedics Ltd. (Aurora) Aurora, Spa Park Harrison Way Leamington Spa United Kingdom·Product code NXT·July 14, 2021

Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING DYSPLASIA CUP W/IMPACTOR, REF Numbers: 74120246 (46 MM), 74122248 (48 MM), 74120250 (50 MM), 74122252 (52 MM), 74120254 (54 MM) Product Usage: Hip joint prosthesis

FDA Enforcement
Class II ·Terminated·Smith & Nephew, Inc.·September 16, 2015

Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING FEMORAL HEAD, STERILE R, Rx only, REF Numbers: 74121138 (38 MM), 74123140 (40 MM), 74121142 (42 MM), 74123144 (44 MM), 74121146 (46 MM). Product Usage: Hip joint prosthesis

FDA Enforcement
Class II ·Terminated·Smith & Nephew, Inc.·September 16, 2015

Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING ACETABULAR CUP W/IMPACTOR, REF Numbers: 74120144 (44 MM), 74120146 (46 MM), 74122146 (46 MM), 74122148 (48 MM), 74120148 (48 MM), 74120150 (50 MM), 74122150 (50 MM), 74122152 (52 MM), 74120152 (52 MM), 74120154 (54 MM) Product Usage: Hip joint prosthesis

FDA Enforcement
Class II ·Terminated·Smith & Nephew, Inc.·September 16, 2015

Guidant Rapido 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall Length 54 cm, Coronary Sinus - Extended Hook Right Tip Shape, CS-EH R, REF 7592

FDA Recall
Terminated ·Guidant Corp-Cpi Division·Product code DQR·March 11, 2004

Guidant Rapido 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall Lenght 54 cm, Coronary Sinus - Extended Hook Right Tip Shape, CS-EH R, REF 7592

FDA Recall
Terminated ·Guidant Corp-Cpi Division·Product code DQR·March 11, 2004

Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup W/ Impactor, 46 mm cup Ref.: 74120146

FDA Recall
Terminated ·Smith & Nephew Inc·Product code LXH·March 13, 2007

Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup W/ Impactor, 58 mm cup Ref.: 74120158

FDA Recall
Terminated ·Smith & Nephew Inc·Product code LXH·March 13, 2007

Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup W/ Impactor, 56 mm cup Ref.: 74120156

FDA Recall
Terminated ·Smith & Nephew Inc·Product code LXH·March 13, 2007

Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup W/ Impactor, 50 mm cup Ref.: 74120150

FDA Recall
Terminated ·Smith & Nephew Inc·Product code LXH·March 13, 2007

Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup W/ Impactor, 60 mm cup Ref.: 74120160

FDA Recall
Terminated ·Smith & Nephew Inc·Product code LXH·March 13, 2007

FFR Link-FFR Signal Processing Module, Material Number H7495551000 It is intended to condition physiological signals from measuring devices (BSC Pressure Guidewire or an external pressure transducer), transmit and receive via radiofrequency, and recondition the signals so they can be displayed on and/or recorded in a receiving device (iLab POLARIS Multi-Modality Guidance System or other monitoring device). The physiological signals can also be distributed by cable

FDA Enforcement
Class II ·Terminated·Boston Scientific Corporation·September 20, 2017

BrightView X are gamma cameras; Designed for single or dual detector nuclear imaging.

FDA Recall
Terminated ·Philips Medical Systems (Cleveland) Inc·Product code KPS·December 17, 2015

BrightView are gamma cameras; Designed for single or dual detector nuclear imaging.

FDA Recall
Terminated ·Philips Medical Systems (Cleveland) Inc·Product code KPS·December 17, 2015

Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING DYSPLASIA CUP W/IMPACTOR, REF Numbers: 74120246 (46 MM), 74122248 (48 MM), 74120250 (50 MM), 74122252 (52 MM), 74120254 (54 MM) Product Usage: Hip joint prosthesis

FDA Recall
Terminated ·Smith & Nephew, Inc.·Product code NXT·June 3, 2015

BrightView XCT & BrightView XCT Upgrade, gamma cameras; For Single Proton Emission Computed Tomography.

FDA Recall
Terminated ·Philips Medical Systems (Cleveland) Inc·Product code KPS·December 17, 2015

Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING FEMORAL HEAD, STERILE R, Rx only, REF Numbers: 74121138 (38 MM), 74123140 (40 MM), 74121142 (42 MM), 74123144 (44 MM), 74121146 (46 MM). Product Usage: Hip joint prosthesis

FDA Recall
Terminated ·Smith & Nephew, Inc.·Product code NXT·June 3, 2015

Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING ACETABULAR CUP W/IMPACTOR, REF Numbers: 74120144 (44 MM), 74120146 (46 MM), 74122146 (46 MM), 74122148 (48 MM), 74120148 (48 MM), 74120150 (50 MM), 74122150 (50 MM), 74122152 (52 MM), 74120152 (52 MM), 74120154 (54 MM) Product Usage: Hip joint prosthesis

FDA Recall
Terminated ·Smith & Nephew, Inc.·Product code NXT·June 3, 2015

BrightView X are gamma cameras; Designed for single or dual detector nuclear imaging.

FDA Enforcement
Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·March 9, 2016