34 results · 21ms · Sources: EU EUDAMED, US FDA

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O2Vent W

FDA 510(k)
FDA Class 2 ·Dental

NA

FDA UDI
KEY SURGICAL, INC.·10849771049569·K-Wires, Single trocar, Threaded, .062-inch (1....

Key Surgical K-Wires and Steinmann Pins

FDA UDI
KEY SURGICAL, INC.·00849771012962·K-Wires, Single trocar, Threaded, .062-inch (1....

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

APEX Knee System

FDA UDI
Omni Life Science, Inc.·00841690191728·Revision Tibia Impactor Pad (Green)

SR PIP

FDA UDI
Stryker GmbH·00886385019758·SIZE 2: PIP PROXIMAL TRIAL

INTEGRAL X-SERIES HIP SYSTEM

FDA UDI
Biomet Orthopedics, LLC·00880304650459·

AAP CANNULATED SCREWS

FDA 510(k)
FDA Class 2 ·Orthopedic

MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL-STREPTOMYCIN SYNERGY SCREEN

FDA 510(k)
FDA Class 2 ·Microbiology

STIMQ PERIPHERAL NERVE STIMULATOR (PNS) SYSTEM

FDA Adverse Event
Injury ·STIMWAVE TECHNOLOGIES INC.·Product code GZF·December 20, 2018

MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT

FDA Adverse Event
Injury ·ETHICON INC.·Product code GAN·September 5, 2019

SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·October 14, 2014

OT PING METER

FDA Adverse Event
Malfunction ·LIFESCAN INC.·Product code NBW·July 21, 2011

ULTRAFLEX COVERED NG ESOPHAGEAL STENT

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC·Product code ESW·September 17, 2008

STIMQ PERIPHERAL NERVE STIMULATOR (PNS) SYSTEM

FDA Adverse Event
Injury ·STIMWAVE TECHNOLOGIES INC.·Product code GZF·April 1, 2019

PENUMBRA COIL 400

FDA Adverse Event
Injury ·PENUMBRA, INC.·Product code HCG·November 29, 2016

ALINITY C PROCESSING MODULE

FDA Adverse Event
Malfunction ·ABBOTT LABORATORIES·Product code JJE·April 3, 2025

Alaris System PC Unit Model 8015. modular infusion pump and monitoring system

FDA Recall
Terminated ·CareFusion 303, Inc.·Product code FRN·June 30, 2020

Alaris Pump Module Model 8100

FDA Recall
Terminated ·CareFusion 303, Inc.·Product code FRN·June 30, 2020

CareFusion Alaris Pump Module, Model 8100

FDA Recall
Open, Classified ·CareFusion 303, Inc.·Product code FRN·February 4, 2020