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

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MOUNTAINEER OCT SPINAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

DR COMFORT

FDA UDI
DJO, LLC·00888912235631·Sheer ThighHs OT W 20-30 Nude

Oticon

FDA UDI
Oticon A/S·05707131258472·H16, MINIRITE 312 WL TC

Ophthalmic Spatula

FDA UDI
KATENA PRODUCTS, INC.·00841668102459·ANIS PHACO CHOPPER, RIGHT

FINE JECT INSULIN PEN NEEDLE

FDA 510(k)
FDA Class 2 ·General Hospital

ROCHE ONLINE TDM QUINIDINE

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 7

FDA Adverse Event
Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code MEH·May 29, 2013

3002 SECURE II

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code FNL·June 13, 2011

INGENIO

FDA Adverse Event
Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·October 1, 2014

EVOLUT FX VALVE

FDA Adverse Event
Injury ·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·August 27, 2025

XVWEB

FDA Adverse Event
Injury ·PLANET DDS·Product code LLZ·March 13, 2025

SECOND OPINION

FDA Adverse Event
Injury ·PEARL INC.·Product code MYN·March 13, 2025

AMISTEM H, HA COATED STEM SIZE 6 LAT

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·November 18, 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