21 results · 25ms · Sources: EU EUDAMED, US FDA

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COLUMBUS (PS)

FDA 510(k)
FDA Class 2 ·Orthopedic

TriVerse Femoral Component CR

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215100162·

SECURMIX

FDA 510(k)
FDA Class 2 ·General Hospital

ORION PLATINUM

FDA 510(k)
FDA Class 2 ·Neurology

ZEPHIR® ANTERIOR CERVICAL SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS·Product code KWQ·April 24, 2014

UNK-RAILWAY

FDA Adverse Event
Injury ·CORDIS CORPORATION·Product code DRE·August 5, 2020

ZEPHIR ANTERIOR CERVICAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDIC, INC.·Product code KWP·February 18, 2011

ERBE

FDA Adverse Event
Malfunction ·LEONHARD LANG GMBH·Product code GEI·November 2, 2022

ZEPHIR ANTERIOR CERVICAL SYSTEM

FDA Adverse Event
Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWQ·January 3, 2017

ZEPHIR ANTERIOR CERVICAL SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS·Product code KWQ·September 20, 2013

GYNECARE X-TRACT MORCELLATOR

FDA Adverse Event
Malfunction ·ETHICON, INC.·Product code HET·April 2, 2013

ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

FDA Adverse Event
Malfunction ·COOK INC·Product code MIH·March 21, 2011

BIPOL LEAD MODEL

FDA Adverse Event
Malfunction ·CYBERONICS, INC.·Product code LYJ·April 16, 2008

ZEPHIR ANTERIOR CERVICAL SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS·Product code KWQ·October 12, 2011

Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x35 mm Catalog Number: 18965035S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

FDA Enforcement
Class II ·Terminated·Stryker GmbH·June 24, 2020

UNK-RAILWAY

FDA Adverse Event
Injury ·CORDIS CORPORATION·Product code DRE·August 7, 2020

ERBE

FDA Adverse Event
Malfunction ·LEONHARD LANG GMBH·Product code GEI·March 8, 2023

ERBE

FDA Adverse Event
Malfunction ·LEONHARD LANG GMBH·Product code GEI·February 18, 2025

ERBE

FDA Adverse Event
Injury ·LEONHARD LANG GMBH·Product code GEI·July 27, 2022

FEM IM NAIL 14MMDX30CM LEFT, FEM IM NAIL 14MMDX30CM RIGHT FEM IM NAIL 13MMDX32CM LEFT FEM IM NAIL 14MMDX32CM LEFT FEM IM NAIL 13MMDX32CM RIGHT FEM IM NAIL 14MMDX32CM RIGHT FEM IM NAIL 11MMDX34CM LEFT FEM IM NAIL 13MMDX34CM LEFT FEM IM NAIL 14MMDX34CM LEFT FEM IM NAIL 11MMDX34CM RIGHT FEM IM NAIL 13MMDX34CM RIGHT FEM IM NAIL 14MMDX34CM RIGHT FEM IM NAIL 11MMDX36CM LEFT FEM IM NAIL 12MMDX36CM LEFT FEM IM NAIL 13MMDX36CM LEFT FEM IM NAIL 14MMDX36CM LEFT FEM IM NAIL 11MMDX36CM RIGHT FEM IM NAIL 12MMDX36CM RIGHT FEM IM NAIL 13MMDX36CM RIGHT FEM IM NAIL 14MMDX36CM RIGHT FEM IM NAIL 10MMDX38CM LEFT FEM IM NAIL 11MMDX38CM LEFT FEM IM NAIL 12MMDX38CM LEFT FEM IM NAIL 13MMDX38CM LEFT FEM IM NAIL 14MMDX38CM LEFT FEM IM NAIL 10MMDX38CM RIGHT FEM IM NAIL 11MMDX38CM RIGHT FEM IM NAIL 12MMDX38CM RIGHT FEM IM NAIL 13MMDX38CM RIGHT FEM IM NAIL 14MMDX38CM RIGHT FEM IM NAIL 10MMDX40CM LEFT FEM IM NAIL 11MMDX40CM LEFT FEM IM NAIL 12MMDX40CM LEFT FEM IM NAIL 13MMDX40CM LEFT FEM IM NAIL 14MMDX40CM LEFT FEM IM NAIL 10MMDX40CM RIGHT FEM IM NAIL 11MMDX40CM RIGHT FEM IM NAIL 12MMDX40CM RIGHT FEM IM NAIL 13MMDX40CM RIGHT FEM IM NAIL 14MMDX40CM RIGHT FEM IM NAIL 10MMDX42CM LEFT FEM IM NAIL 11MMDX42CM LEFT FEM IM NAIL 12MMDX42CM LEFT FEM IM NAIL 13MMDX42CM LEFT FEM IM NAIL 14MMDX42CM LEFT FEM IM NAIL 10MMDX42CM RIGHT FEM IM NAIL 11MMDX42CM RIGHT FEM IM NAIL 12MMDX42CM RIGHT FEM IM NAIL 13MMDX42CM RIGHT FEM IM NAIL 14MMDX42CM RIGHT FEM IM NAIL 10MMDX44CM LEFT FEM IM NAIL 11MMDX44CM LEFT FEM IM NAIL 12MMDX44CM LEFT FEM IM NAIL 13MMDX44CM LEFT FEM IM NAIL 14MMDX44CM LEFT FEM IM NAIL 10MMDX44CM RIGHT FEM IM NAIL 11MMDX44CM RIGHT FEM IM NAIL 12MMDX44CM RIGHT FEM IM NAIL 13MMDX44CM RIGHT FEM IM NAIL 14MMDX44CM RIGHT FEM IM NAIL 10MMDX46CM LEFT FEM IM NAIL 11MMDX46CM LEFT FEM IM NAIL 12MMDX46CM LEFT FEM IM NAIL 13MMDX46CM LEFT FEM IM NAIL 14MMDX46CM LEFT FEM IM NAIL 10MMDX46CM RIGHT FEM IM NAIL 11MMDX46CM RIGHT FEM IM NAIL 12MMDX46CM RIGHT FEM IM NAIL 13MMDX46CM RIGHT FEM IM NAIL 14MMDX46CM RIGHT FEM IM NAIL 10MMDX48CM LEFT FEM IM NAIL 11MMDX48CM LEFT FEM IM NAIL 12MMDX48CM LEFT FEM IM NAIL 13MMDX48CM LEFT FEM IM NAIL 10MMDX48CM RIGHT FEM IM NAIL 11MMDX48CM RIGHT FEM IM NAIL 12MMDX48CM RIGHT FEM IM NAIL 13MMDX48CM RIGHT FEM IM NAIL 10MMDX50CM LEFT FEM IM NAIL 11MMDX50CM LEFT FEM IM NAIL 12MMDX50CM LEFT FEM IM NAIL 13MMDX50CM LEFT FEM IM NAIL 10MMDX50CM RIGHT FEM IM NAIL 11MMDX50CM RIGHT FEM IM NAIL 12MMDX50CM RIGHT FEM IM NAIL 13MMDX50CM RIGHT

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·June 21, 2017