10 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COLORADO II SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Polystar HK
FDA UDI
Merz Dental GmbH·D7091984360·anteriors; shade B4; mould Q 45
Masel
FDA UDI
Ortho Organizers, Inc.·00190707035501·.016 X .016 Lower Elastinol™ Natural Form Archw...
Sklar
FDA UDI
SKLAR CORPORATION·10649111347108·MICRO FCP CVD 6MM X.7MM 8.25 IN
SEIKO P-6 PROGRESSIVE SPECTACLE LENSES
FDA 510(k)
FDA Class 1
·Ophthalmic
MODEL 280 INFUSION PUMP
FDA 510(k)
FDA Class 2
·General Hospital
RIATA ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·February 28, 2013
ASR UNI FEMORAL IMPL SIZE 43
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·January 27, 2011
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE REHABILITATION EQUIP·Product code CAW·August 6, 2014
Vanguard XP Tibial Tray 69 mm Item # 195248
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 2019