12 results
·
21ms
·
Sources: EU EUDAMED, US FDA
MEDSURG POTT-COURNAND NEEDLE
FDA 510(k)
FDA Class 2
·Cardiovascular
Colored Chain
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746058462·CHAIN PLASTIC 15' SHORT PURPLE
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209128075·
Colored Chain
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746033438·CHAIN PLASTIC 15' SHORT PURPLE
AUTO DII MULTI FREQUENCY
FDA 510(k)
FDA Class 2
·Radiology
ELECTRONIC CELL ENERGIZER
FDA 510(k)
FDA Class 2
·Physical Medicine
PLV-100
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code CBK·November 28, 2012
SETROX S 53
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVN·June 6, 2014
TERUMO CDI 100 MONITOR
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTY·September 30, 2010
DEPTH GAUGE FOR SMALL SCREWS
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HTJ·June 18, 2019
Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
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