9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PHILIPS DUO DIAGNOST
FDA 510(k)
FDA Class 2
·Radiology
Polystar Selection EDITION HD
FDA UDI
Merz Dental GmbH·D7091983069·posteriors; shade B4; size M; lower jaw
EZLASE 10W
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NobelZygoma 0°
FDA 510(k)
FDA Class 2
·Dental
ENDOVIVE¿ SAFETY PEG KIT
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code KNT·February 28, 2013
INTERSTIM
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·February 4, 2011
RF GEN OBSOLETE REPLACED BY 0406900000
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code GXD·August 6, 2014
Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long; Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long are system specific instruments to the 3.5 mm Low Profile Pelvic System Retractor Set.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·August 26, 2015
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