8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
PANACRYL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SLIM LINE RETENT TIP W/SILICONE INFLATION CUFF
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
N-TACT PTH BY IMMUNORADIOMETRIC ASSAY (IRMA)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code BRZ·February 22, 2013
PRECISION TEST STRIPS
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE, INC. USA·Product code NBW·January 31, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 1, 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