12 results · 20ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

Oneday Implant Abutment

FDA 510(k)
FDA Class 2 ·Dental

Lumipulse G B-Amyloid 1-40 Immunoreaction Cartridges

FDA UDI
FUJIREBIO INC.·04987270231753·

BD BBL™ Sensi-Disc™ Ceftazidime/Clavulanic Acid 30/10 µg

FDA UDI
BECTON, DICKINSON AND COMPANY·00382902317531·BD BBL™ Sensi-Disc™ Ceftazidime/Clavulanic Acid...

LOCKING SCREW, FULLY THREADED 5X45 MM

FDA Adverse Event
Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·October 30, 2009

KARATS MULTIPURPOSE SOLUTION

FDA 510(k)
FDA Class 2 ·Ophthalmic

MERIDIAN

FDA 510(k)
FDA Class 2 ·Dental

SMARTMONITOR 2 PROFESSIONAL SERIES MONITOR/OXIMETER - HOSPITAL

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code NPF·October 14, 2014

STERLING ES PTA BALLOON DILATATION CATHETER

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LIT·September 1, 2011

TRUERESULT

FDA Adverse Event
Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code NBW·July 15, 2013

COBAS® DPX - 192T

FDA Adverse Event
Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QHO·September 17, 2025

Revogene, Catalog no. 610210. IVD test instrument

FDA Enforcement
Class II ·Ongoing·Meridian Bioscience Inc·August 3, 2022

Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

FDA Enforcement
Class II ·Terminated·Philips North America, LLC·March 25, 2020