8 results · 32ms · Sources: EU EUDAMED, US FDA

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RANDOX MICROALBUMIN CONTROL LEVEL 1 AND CONTROL LEVEL 2 (LIQUID)

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

Northern Labs Inc

FDA registration
Northern Labs Inc·1 product·🇺🇸 United States

THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY

FDA 510(k)
FDA Unclassified ·Unknown

SQA V, SPERM QUALITY ANALYZER

FDA 510(k)
FDA Class 2 ·Hematology

SERVO-I

FDA Adverse Event
Malfunction ·MAQUET CRITICAL CARE AB·Product code CBK·May 8, 2013

POWERED WHEELCHAIR

FDA Adverse Event
Malfunction ·INVACARE TAYLOR STREET·Product code ITI·September 26, 2014

ESSURE

FDA Adverse Event
Malfunction ·BAYER PHARMA AG·Product code HHS·May 20, 2011

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