49 results · 13ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

MicroScan LabPro Information Manager System, Software Versions 1.0 to 4.41 Catalog No. 10638819, 10638820, 10638823, 10638824, 10638825,10638826, 10714149,10714159, 10805072, 10805073, 10975000, 10975001, 6000-0008, 6000-0026. Japan: 10638819 LabPro v4.11 Software Update Kit 10638820 LabPro v4.11 System Software 10805072 LabPro MBT Non-Connect Systems v4.30 10805073 LabPro MBT Connect Systems v4.30 Canada: 6000-0008 LabPro v4.41 Panel Update-06 Kit 6000-0026 LabPro Connect v4.41 Panel Update-06 Kit 10638823 LabPro v4.11 Software Update Kit 10638825 LabPro v4.11 System Software 10638824 LabPro v4.11 Software Update Kit Europe: 10638824 LabPro v4.11 Software Update Kit 10638826 LabPro v4.11 System Software USA: 10714149, LabPro v4.11 Software Update Kit 10714150 LabPro v4.11 System Software 10975000 ASM LabPro-MBT v4.40 10975001 ASM LabPro-MBT v4.40 for Connect 6000-0008 LabPro v4.41 Panel Update-06 Kit 6000-0026 LabPro Connect v4.41 Panel Update-06 Kit ROW: 6000-0008 LabPro v4.41 Panel Update-06 Kit 10638823 LabPro v4.11 Software Update Kit 10638825 LabPro v4.11 System Software 10638824 LabPro v4.11 Software Update Kit 10638826 LabPro v4.11 System Software Product Usage: LabPro Data Management System is a Microsoft Windows based software program and is intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST) data generated from MicroScan instruments or manually entered microbiology test results, for use by trained laboratory personnel. LabPro AlertEx is a functional subset of the LabPro Data Management System that analyzes MicroScan ID and AST data, or other predefined parameters, against a series of established rules/alerts and notifies the user of unusual and/or critical conditions, which may warrant further analysis or actions.

FDA Recall
Terminated ·Beckman Coulter Inc.·Product code OUG·February 11, 2016

SIGMA HP MBT Non-Keel Punch Knee Instrument. Designed to be used as an option in stabilizing the tibial trial during trial reduction.

FDA Recall
Terminated ·DePuy Orthopaedics, Inc.·Product code LRY·January 8, 2016

The LCS COMPLETE P.F.C.TM SIGMA RP Mobile Bearing Total Knee System - Product Usage: consists of three components intended to replace the femoral, tibial, and patellar articular surfaces of the knee joint.

FDA Recall
Terminated ·DePuy Orthopaedics, Inc.·Product code NJL·February 22, 2021

The ATTUNE Rotating Platform (RP) Total Knee System - Product Usage: consists of multiple components intended to replace the femoral, tibial, and patellar articular surfaces of the knee joint.

FDA Recall
Terminated ·DePuy Orthopaedics, Inc.·Product code NJL·February 22, 2021

SIGMA LCS HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.

FDA Recall
Terminated ·DePuy Orthopaedics, Inc.·Product code LXH·November 18, 2013

SIGMA LCS HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.

FDA Recall
Terminated ·DePuy Orthopaedics, Inc.·Product code JWH·November 18, 2013

SIGMA LCS HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.

FDA Recall
Terminated ·DePuy Orthopaedics, Inc.·Product code JWH·November 18, 2013

SIGMA LCS HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.

FDA Recall
Terminated ·DePuy Orthopaedics, Inc.·Product code JWH·November 18, 2013

SIGMA LCS HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.

FDA Recall
Terminated ·DePuy Orthopaedics, Inc.·Product code JWH·November 18, 2013

SIGMA LCS HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.

FDA Recall
Terminated ·DePuy Orthopaedics, Inc.·Product code LXH·November 18, 2013

ATTUNE FIXED BEARING KNEE - Product Usage: composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee joint. The femoral component is a metal implant without a porous coating. The tibial component may be an all polyethylene component or comprised of a metal tibial base without porous coating, and a polyethylene insert and locking components. The patella component may be of an all polyethylene design.

FDA Recall
Terminated ·DePuy Orthopaedics, Inc.·Product code JWH·February 22, 2021

SIGMA LCS HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.

FDA Recall
Terminated ·DePuy Orthopaedics, Inc.·Product code JWH·November 18, 2013

SIGMA LCS HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty

FDA Recall
Terminated ·DePuy Orthopaedics, Inc.·Product code JWH·November 18, 2013

SIGMA LCS HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.

FDA Recall
Terminated ·DePuy Orthopaedics, Inc.·Product code JWH·November 18, 2013

SIGMA LCS HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.

FDA Recall
Terminated ·DePuy Orthopaedics, Inc.·Product code JWH·November 18, 2013

SIGMA LCS HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED SIZE 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.

FDA Recall
Terminated ·DePuy Orthopaedics, Inc.·Product code JWH·November 18, 2013

SIGMA LCS HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.

FDA Recall
Terminated ·DePuy Orthopaedics, Inc.·Product code JWH·November 18, 2013

Accusorb MRI MAC7007 Part Number: MRI-07 MRI-Breast Shield Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

FDA Recall
Terminated ·MWT Materials, Inc.·Product code LNH·October 6, 2014

Accusorb MRI MAC7010 Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

FDA Recall
Terminated ·MWT Materials, Inc.·Product code LNH·October 6, 2014

Accusorb MRI MAC7004 Part Number: MRI-04 MRI-Poncho Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

FDA Recall
Terminated ·MWT Materials, Inc.·Product code LNH·October 6, 2014