10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SIDESTREAM DISPOSABLE
FDA 510(k)
FDA Class 2
·Anesthesiology
RIWO-ART
FDA UDI
Richard Wolf GmbH·04055207022610·TROCAR TIP TRIANGULAR SZ 12.7MM WL 164MM dista...
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123090·K-WIRE - DOUBLE TROCAR 1.2mm DIA x 75mm
SERIM RESIDUAL FORMALDEHYDE REAGENT STRIPS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CIBA CORNING ACS HCG IMMUNOASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ENDO CATCH GOLD
FDA Adverse Event
Injury
·DAVIS & GECK CARIBE LTD·Product code GCI·June 11, 2018
SPRINT QUATTRO SECURE
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·December 14, 2010
MINICAP TRANSFER SET
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·January 22, 2013
TENDRIL SDX
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·July 9, 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