10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GoLIF! Lumbar Interbody Fusion System
FDA 510(k)
FDA Class 2
·Orthopedic
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780188568·Integra® Jarit® Hibbs Gouge, 9-1/2", Straight, 1"
Analog
FDA UDI
BICON, LLC·00813110025173·6.5mm Stealth Abutment Analog
Chariot Guiding Sheath
FDA 510(k)
FDA Class 2
·Cardiovascular
AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL III
FDA 510(k)
FDA Class 2
·Clinical Toxicology
CRE BALLOON DILATATION CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code KNQ·September 15, 2011
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL MANUFACTURING CORPORATION·Product code MVK·November 6, 2014
MIDLINE CATHETERIZATION SET
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC·Product code DQY·July 24, 2013
Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS Only);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013