12 results
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18ms
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Sources: EU EUDAMED, US FDA
MODEL 600 MEDICAL TREATMENT TABLE
FDA 510(k)
FDA Class 1
·Physical Medicine
Class B 21 BBP - FAC-5 Cabinet
FDA UDI
Certified Safety Manufacturing, Inc.·00766588233253·Class B 21 BBP - FAC-5 Cabinet
Instrument Case
FDA UDI
KATENA PRODUCTS, INC.·00841668111055·SILICONE MAT FOR K 9-2320
Instrument Case
FDA UDI
KATENA PRODUCTS, INC.·00841668111079·SILICONE MAT FOR K 9-2330
SuperDART® ONE PASS™ Validated Channel Cleaning Device
FDA UDI
Primed Instruments Inc·00666416121335·BRUSH CLEANING 3 TO 4.5MM X 85CM MULTI ACTION P...
Medafor Direct Gas-Assisted Application System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
uMI Panorama
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·July 17, 2015
ASR ACETABULAR IMPLANT 54
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·January 22, 2013
TENDRIL ST
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·July 9, 2014
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HWC·February 6, 2017
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