8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
BUHLMANN ANGIOSTENSIN II RIA
FDA 510(k)
FDA Class 2
·Clinical Chemistry
GORE-TEX PERIODONTAL MATERIAL
FDA 510(k)
FDA Class 2
·Dental
SLIM LINE RETENT TIP W/SILICONE INFLATION CUFF
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·January 9, 2013
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·January 10, 2011
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 24, 2014
3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod¿, Part Number (Item #) AG8049-NS, Lot # 2528655. K914299. Waste system.
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·October 17, 2012
3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod, Part Number (Item #) AG8049-NS, Lot # 2528655. K914299. Waste system.
FDA Recall
Terminated
·ICU Medical, Inc.·Product code DQO·September 28, 2012