15 results · 22ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

ACUSON S3000 S2000 S1000 Diagnostic Ultrasound Systems

FDA 510(k)
FDA Class 2 ·Radiology

CONICAL CONNECTION IMPLANTS

FDA 510(k)
FDA Class 2 ·Dental

PARCUS PEEK CF PUSH-IN SUTURE ANCHOR

FDA 510(k)
FDA Class 2 ·Orthopedic

GMK-REVISION 02.07.0314SCF FIXED TIBIAL INSERT SC SIZE 3/14MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·February 6, 2019

LOCKING PROXIMAL FEMUR SYSTEM CORTICAL SCREWS

FDA Adverse Event
Injury ·ORTHOPEDIATRICS, CORP·Product code HWC·February 14, 2020

GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/14MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·February 29, 2024

LOCKING PROXIMAL FEMUR SYSTEM CORTICAL SCREWS

FDA Adverse Event
Injury ·ORTHOPEDIATRICS, CORP·Product code HWC·February 14, 2020

LOCKING PROXIMAL FEMUR SYSTEM CORTICAL SCREWS

FDA Adverse Event
Injury ·ORTHOPEDIATRICS, CORP·Product code HWC·February 14, 2020

9900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 11, 2013

GREENLIGHT ADDSTAT

FDA Adverse Event
Malfunction ·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·June 15, 2011

COLLEAGUE CX VOLUMETRIC INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 25, 2008

TRUE METRIX

FDA Adverse Event
Malfunction ·TRIVIDIA HEALTH INC·Product code NBW·August 12, 2020

COOK CELECT NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET

FDA Adverse Event
Malfunction ·WILLIAM COOK EUROPE·Product code DTK·August 29, 2017

UNKNOWN

FDA Adverse Event
Injury ·WILLIAM COOK EUROPE·Product code DTK·July 10, 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