9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
DISPOSABLE BACTERIA FILTER
FDA 510(k)
FDA Class 2
·Anesthesiology
AirLife™
FDA UDI
VYAIRE MEDICAL, INC.·10190752176744·KIT AUTOFEED POLE/BRKT
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209137879·
AUDICOR 200 SYSTEM, MODELS 200D AND 200S
FDA 510(k)
FDA Class 2
·Cardiovascular
Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs
FDA 510(k)
FDA Class 1
·General Hospital
INFUSOMAT SPACE - US VERSION
FDA Adverse Event
Injury
·B. BRAUN MELSUNGEN AG·Product code FRN·April 17, 2014
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·ROCHE INSULIND DELIVERY SYSTEMS INC.·Product code LZG·September 28, 2012
HEARTSTART MRX -EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·July 21, 2010
Extremity Pack, Kit number AMS2726, AMS2937, AMS3240, PSS1381(A PSS1381(B, PSS1798(A, PSS1842(A, and PSS2706 convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016