10 results
·
26ms
·
Sources: EU EUDAMED, US FDA
BIOBRANE BRAND TEMPORARY WOUND-DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
ACUMED
FDA UDI
Acumed LLC·10806378050527·Polarus® 3 Cap Screw Driver
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209130146·
TD-4239 BLOOD GLUCOSE MONITORING SYSTEM AND TD-4239 MULTI BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
INTEGRA MESHED BILAYER WOUND MATRIX
FDA 510(k)
FDA Unclassified
·Unknown
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code IOR·May 9, 2014
COBAS INTEGRA 800
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·October 23, 2012
FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC., USA·Product code NBW·September 27, 2007
POLARUS® 3 PROXIMAL LOCKING NAIL 150MM L
FDA Adverse Event
Malfunction
·ACUMED, LLC·Product code LXH·January 8, 2025
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024