10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TOTAL OSSICULAR REPLACEMENT PROSTHESIS (TORP)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
PULSION PICCO-2, MODEL 8500
FDA 510(k)
FDA Class 2
·Cardiovascular
WR19 System
FDA 510(k)
FDA Class 2
·Neurology
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·February 21, 2013
MICRO OSCILLATING SAW
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code ERL·January 21, 2011
COBAS INTEGRA 800
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·August 1, 2014
DATASCOPE MR MONITOR
FDA Adverse Event
Malfunction
·DATASCOPE CORP./PT MONITORING DIVISION·Product code MHX·January 23, 2003
PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code HSX·October 15, 2025
GENESIS UNI KNEE FEMORAL COMPONENT COCR
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code HSX·May 23, 2025
Knee Arthroscopy Pack , part number AMS2610(A Knee Arthroscopy Pack, part number AMS3236(A Knee Arthroscopy Pack, part numbre AMS3860
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017