11 results · 26ms · Sources: EU EUDAMED, US FDA

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ONETOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

OT VERIO2 METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 8, 2016

QCA (VERSION 3.1)

FDA 510(k)
FDA Class 2 ·Hematology

VU CPOD INTERVERTEBRAL BODU FUSION DEVICE

FDA 510(k)
FDA Class 2 ·Orthopedic

RELOAD FOR 60MM ECHELON

FDA Adverse Event
Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·October 22, 2021

URETEX INTRODUCER NEEDLE X1

FDA Adverse Event
Injury ·SOFRADIM PRODUCTION·Product code FTL·May 20, 2013

REFEXION BI-DIRECTIONAL DECAPOLAR

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL·Product code DRF·June 14, 2011

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FDA Adverse Event
DEROYAL INDUSTRIES·Product code FSY·August 11, 2008

BD PHOENIX¿ PMIC/ID-107

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·November 18, 2024

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

Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,

FDA Enforcement
Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025