11 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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
*
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