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

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MagVita TMS Therapy System

FDA 510(k)
FDA Class 2 ·Neurology

HNM Women Care

FDA UDI
HNM STAINLESS, LLC.·00812171027638·PESSARY, CUP #2, W/O SUPPORT, 60/28mm

INTRACEPT FLEXIBLE BI-POLAR RF PROBE AND EASY ACCESS INSTRUMENT SET, MODEL FG0018 (PROBE), FG0036 (INSTRUMENT SET)

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

ZYGOMA TIUNITE

FDA 510(k)
FDA Class 2 ·Dental

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 8, 2014

HOMECHOICE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·June 6, 2013

VITROS 5600 INTEGRATED SYSTEM

FDA Adverse Event
Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code MMI·July 6, 2011

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

cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

FDA Enforcement
Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018