12 results
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18ms
·
Sources: EU EUDAMED, US FDA
IMMUNOMATRIX THEOPHYLINE ASSAY SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Toxicology
QIAcuityDx® Four
FDA UDI
QIAGEN GmbH·04053228048770·The QIAcuityDx® Four is an automated digital PC...
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756393706·EYE PACK
TAPAS® Catheter
FDA UDI
Thermopeutix, Inc.·M7819110601·The TAPAS® Catheter consists of a two concentri...
Gen. Acces/ Instr. Tip Guard
FDA UDI
KATENA PRODUCTS, INC.·00841668112311·SURG-I-BAND BLUE
ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller Kit
FDA 510(k)
FDA Class 2
·Cardiovascular
MRGFUS PELVIC PA COIL MODEL 1.0
FDA 510(k)
FDA Class 2
·Radiology
NEUTRAL LINER 36 MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·December 19, 2019
LRG TAP PRI MOD NCK 0DEG 34MM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS CORK·Product code MEH·January 4, 2013
ANEURX AAADVANTAGE STENT GRAFT SYSTEM - HYDRO
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR GALWAY·Product code MIH·November 24, 2010
FORTIFY DR, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·July 2, 2014
EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·September 29, 2021