11 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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GELPOINT PATH
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450427224·
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·December 31, 2014
MAMMOGRAPH
FDA 510(k)
FDA Class 2
·Radiology
LIV LINDE INTERGRATED VALVE-PORTABLE OXYGEN SYSTEM, MODEL M706
FDA 510(k)
FDA Class 1
·Anesthesiology
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·May 9, 2013
PINN MAR +4 10D 32IDX62OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·September 23, 2014
CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·June 1, 2011
CollaCote Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corporation·May 22, 2013
Video Duodenoscope
FDA Enforcement
Class II
·Terminated·Pentax Medical Company·June 8, 2016
Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024