9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ANTISERUM TO HUMAN IGM
FDA 510(k)
FDA Class 2
·Immunology
CONTIUOUS WAVE DOPPLER ULTRASOUND
FDA 510(k)
FDA Class 2
·Cardiovascular
CARRAKLENZ AND ULTRAKLENZ
FDA 510(k)
FDA Unclassified
·Unknown
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 21, 2014
PROXIMATE ILS CURVED CIR STAPL
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code GDW·November 27, 2007
VA-LCP CONDYLAR PLATE 4.5/5.0 R 16HO L33
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HRS·November 7, 2012
VANGUARD XP 4IN1 CUT BLOCK ACL PROTECTOR
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code LXH·November 27, 2017
EV3 Pipeline Flex Embolization Device with Flex Shield Technology
FDA Enforcement
Class I
·Ongoing·Micro Therapeutics Inc,·September 15, 2021
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