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

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syngo®.via (version VB10A)

FDA 510(k)
FDA Class 2 ·Radiology

AGXO

FDA UDI
Oticon A/S·05707131280930·H160V2, BTE 13 WL 100 STG AGXO

AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

ABREU, MODEL 700

FDA 510(k)
FDA Class 2 ·General Hospital

ENSITE CLASSIC SYSTEM

FDA Adverse Event
Injury ·ST. JUDE MEDICAL·Product code DQK·February 9, 2010

5.0MM TI LOCKING SCREW W/T25 STARDRIVE 42MM FOR IM NAILS

FDA Adverse Event
Injury ·SYNTHES USA·Product code HWC·September 23, 2016

SYNCHRO2-14 SUPPORT STRAIGHT 215CM

FDA Adverse Event
Malfunction ·STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY·Product code DQX·December 14, 2023

POWERED WHEELCHAIR

FDA Adverse Event
Malfunction ·INVACARE TAYLOR STREET·Product code ITI·June 6, 2013

TOTAL ASR FEM IMP SIZE 45

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·June 29, 2011

9800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 9, 2008

Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

FDA Enforcement
Class II ·Terminated·Ecolab Inc·September 30, 2015