18 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems
FDA 510(k)
FDA Class 2
·Neurology
Symmetry Rochester Ochsner
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482056196·Symmetry® Forceps, Rochester Ochsner, Curved, 1...
THREADED STEINMANN PINS, TROCAR POINT
FDA UDI
Biomet Orthopedics, LLC·00887868016424·
PROSOFT
FDA 510(k)
FDA Class 2
·Dental
CIANNA MEDICAL SGS SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 24, 2025
UNKNOWN
FDA Adverse Event
Injury
·COOK INC·Product code DTK·February 19, 2019
VIVA QUAD XT
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code NIK·October 10, 2014
UNKNOWN DEPUY 6.5 MM CANCELLOUS SCREWS
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code HWC·June 11, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 13, 2011
DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
FDA Adverse Event
Injury
·COOK INC·Product code DTK·February 19, 2019
UNKNOWN
FDA Adverse Event
Injury
·COOK INC·Product code DTK·February 19, 2019
ENTERPRISE2 4MMX23MM NO TIP
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code NJE·December 16, 2020
ENTERPRISE2 4MMX16MM NO TIP
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code NJE·December 16, 2020
UNKNOWN
FDA Adverse Event
Injury
·COOK INC·Product code DTK·February 19, 2019
UNKNOWN
FDA Adverse Event
Injury
·COOK INC·Product code DTK·March 23, 2018
Alligator Retrieval Device The device is intended for use in the peripheral and neurovasculature for foreign body removal. Catalog No. FA-88810-20V04 FA-88810-20V06 FA-88810-30V04 FA-88810-30V06 FA-88810-40V04 FA-88810-40V06 FA-88810-50V04 FA-88810-50V06
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016
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