10 results
·
20ms
·
Sources: EU EUDAMED, US FDA
NDYAG LASER TRACHEAL TUBE
FDA 510(k)
FDA Class 2
·Anesthesiology
PRECISION XCEED PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM WITH MODELS BGMS:70900-03, 70090-02, G3CH STRIPS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
FIXIT / ComposiTCP Threaded Anchor System
FDA 510(k)
FDA Class 2
·Orthopedic
Arcos Modular Revision Hip System High Offset Cone Prox Body, Size D, 80 MM Item Number: 11-301354
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·August 18, 2021
BIOMET ARCOM PATELLA
FDA Adverse Event
Death
·ZIMMER BIOMET, INC.·Product code JWH·November 8, 2018
BIOMET CC CRUCIATE TRAY
FDA Adverse Event
Death
·ZIMMER BIOMET, INC.·Product code JWH·November 7, 2018
VANGUARD PS INTERLOCKING FEMORAL
FDA Adverse Event
Death
·ZIMMER BIOMET, INC.·Product code JWH·November 8, 2018
INFINITI VISION SYSTEM OZIL
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·April 7, 2014
TERUMO CDI 540 CALIBRATOR
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·October 5, 2010
INFAST SLING SYSTEM
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·December 13, 2012