12 results
·
19ms
·
Sources: EU EUDAMED, US FDA
WOVEN AND KNITTED MINICRIMP CAROTID PATCH FABRICS
FDA 510(k)
FDA Class 2
·Cardiovascular
AVENIR MÜLLER, STEM, STANDARD, UNCEMENTED, HA, 3, TAPER 12/14
FDA Adverse Event
Malfunction
·ZIMMER GMBH·Product code LZO·December 11, 2017
AVENIR MÜLLER, STEM, LATERAL, UNCEMENTED, HA, 4, TAPER 12/14
FDA Adverse Event
Malfunction
·ZIMMER GMBH·Product code LZO·December 8, 2017
AVENIR MÜLLER, STEM, LATERAL, UNCEMENTED, HA, 4, TAPER 12/14
FDA Adverse Event
Malfunction
·ZIMMER GMBH·Product code LZO·December 22, 2017
CROMATEST SYPHILIS DIAGNOSTIC
FDA 510(k)
FDA Class 2
·Microbiology
LANDERS VITRECTOMY LENS RING W/INFUSION
FDA 510(k)
FDA Class 1
·Ophthalmic
Avenir Muller Stem; Item Number: 01.06010.104, Lot Number: 2905496, UDI: (01)00889024479500 (17)220430 (10)2905496
FDA Enforcement
Class II
·Terminated·Zimmer GmbH·May 2, 2018
Avenir Muller Stem; Item Number: 01.06010.104, Lot Number: 2905496, UDI: (01)00889024479500 (17)220430 (10)2905496
FDA Recall
Terminated
·Zimmer GmbH Sulzerallee 8 Winterthur Switzerland·Product code LZO·February 28, 2018
VITALITY 2
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·January 9, 2013
PROMOS GLENOID
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code HSD·November 23, 2010
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·July 1, 2014
Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012