14 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NexSite HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm, 28 cm, 32 cm, 36 cm, 40 cm, 55 cm)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ORTHOPEDIC SALVAGE SYSTEM (OSS)
FDA UDI
Biomet Orthopedics, LLC·00880304469310·
Symmetry Rochester-Pean
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482056004·Symmetry® Forceps, Rochester-Pean Hemostatic, S...
ZEUS-T
FDA UDI
SPINAL ELEMENTS·00840916124106·Zeus-TLIF Implant, Size 16H x 10W x 26L
Mui Scientific
FDA UDI
H & A Mui Enterprises Inc·10678467508246·Single Use Esophageal 16 Ch Catheter
Aquila Anterior Cervical Plate System
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215125691·
Pinehurst Anterior Cervical Plate System
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215030636·
APOLLO
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
POWERED PD-IO INFUSION SYSTEM, EZ-IO HUMERAL HEAD, POWERED PH-IO
FDA 510(k)
FDA Class 2
·General Hospital
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013
COULTER LH 750 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code GKZ·June 17, 2011
EXCELLENCE PS+
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·October 10, 2014
MEDISLIM
FDA Adverse Event
Injury
·MEDICREATIONS, LLC·Product code GEX·April 27, 2020
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