10 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PRUITT-INAHARA CAROTID SHUNT 400-40-8F/INAHARA-PRUITT CAROTID SHUNT 500-50-8F
FDA 510(k)
FDA Class 2
·Cardiovascular
P.F.C. SIGMA
FDA UDI
DEPUY (IRELAND)·10603295233749·P.F.C. SIGMA FLUTED FEMORAL STEM 22mm x 175mm 5...
Eye Shield
FDA UDI
KATENA PRODUCTS, INC.·00841668111147·FOX EYE SHIELD W/ GARTER PED PACK OF 50
ENDOPATH ENDOSCOPIC VASCULAR LINEAR CUTTER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code GAG·September 25, 1996
AccuLIF TL and PL Cage
FDA 510(k)
FDA Class 2
·Orthopedic
MODIFICATION TO: CARDIMA ABLATION SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 9, 2014
TENACULUM FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC.·Product code NAY·January 25, 2013
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORP·Product code LZG·December 16, 2010
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024