8 results
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66ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DIASTAT VASCULAR ACCESS GRAFT
FDA 510(k)
FDA Class 2
·Cardiovascular
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704286984·CURETTE ENDOSCOPIC BRUN 3 X 6 MILLIMETER 40 DEG...
QUICKIE CARBON WHEELCHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
ANGESTAT(R) PERICARDIAL DRAINAGE SHEATH SET
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SPRINT QUATTRO
FDA Adverse Event
Injury
·MPRI·Product code LWS·February 11, 2013
TENDRIL ST
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·January 10, 2011
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·July 24, 2014
Sterile surgical convenience kits: 1. regard Item Number: 880353009, GS00797I - Laparotomy Pk; 2. regard Item Number: 880429002, GS01036B - Universal Custom ; 3. regard Item Number: 800725004, GS00930D - OH Base Robot Pack ; 4. regard Item Number: 800725005, GS00930E - OH Base Robot Pack ; 5. regard Item Number: 800395003, GS01000C - Colon Lithotomy and 6. regard Item Number: 880391002, GS00995B - Basic Laparotomy.
FDA Enforcement
Class II
·Ongoing·ROi CPS LLC·May 3, 2023