13 results · 21ms · 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.

VLP Mini-Mod Talus Plates

FDA 510(k)
FDA Class 2 ·Orthopedic

Endo-Model Modular Knee Prosthesis System

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575328345·Femoral Segment,in combination with Size 4

Endo-Model Modular Knee Prosthesis System

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575340743·Femoral Segment,in combination with Size 4

Endo-Model Modular Knee Prosthesis System

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575328369·Femoral Segment,in combination with Size 4

Endo-Model Modular Knee Prosthesis System

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575328352·Femoral Segment,in combination with Size 4

Endo-Model Modular Knee Prosthesis System

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575340750·Femoral Segment,in combination with Size 4

POWDERED VINYL PATIENT EXAMINIATION GLOVES, CLEAR (NON-COLORED)

FDA 510(k)
FDA Class 1 ·General Hospital

DATEX-OHMEDA S/5 CARDIAC OUTPUT MODULE, E-COP AND ACCESSORIES

FDA 510(k)
FDA Class 2 ·Cardiovascular

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·October 8, 2014

ATTAIN ABILITY

FDA Adverse Event
Injury ·MPRI·Product code OJX·June 8, 2013

COMPOUNDERS

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - LARGO·Product code NEP·July 7, 2011

ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

FDA Enforcement
Class II ·Ongoing·Elekta, Inc.·December 13, 2023

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