11 results
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36ms
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Sources: EU EUDAMED, US FDA
FSH ENZYME IMMUNASSAY TEST KIT NO:KIF4057
FDA 510(k)
FDA Class 1
·Clinical Chemistry
N/A
FDA UDI
Tyber Medical, LLC·M695M9152080·
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471150652·K-WIRE - SINGLE TROCAR THREADED 2.0mm DIA x 200mm
BAXTER MARATHON(R) INTRAVASCULAR GUIDING CATHETERS
FDA 510(k)
FDA Class 2
·Cardiovascular
MORSE ANESTHESIA
FDA 510(k)
FDA Class 2
·General Hospital
MOSAIC AORTIC BIOPROSTHETIC HEART VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code DYE·December 15, 2020
PLUM A+ DRIVER ED 2
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·May 16, 2014
DA VINCI SURGICAL SYSTEM
FDA Adverse Event
Death
·INTUITIVE SURGICAL,INC.·Product code NAY·December 6, 2010
HEARTSINE SAMARITAN 300P AND PAD PAK
FDA Adverse Event
Malfunction
·HEARTSINE TECHNOLOGIES LTD·Product code MKJ·December 19, 2012
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
Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024