11 results
·
18ms
·
Sources: EU EUDAMED, US FDA
PREFILLED WATER FOR IRRIGATION USP
FDA 510(k)
FDA Class 2
·Anesthesiology
Archon
FDA UDI
Nuvasive, Inc.·00887517303349·Archon Screw, 4.0x16mm S.T. Fixed Recon
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011880316220·dentaform® Snap, tooth 46,size 15/Roth 22
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011880316180·dentaform® Snap Band, tooth 46,size 16/Roth 18
RABBIT ANTIBODY TO DIGOXIN
FDA 510(k)
FDA Class 2
·Clinical Toxicology
OTICON MODEL E19VF EARETTE HEARING AID
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 30, 2014
ASAHI ASTATO 30 PERIPHERAL GUIDEWIRE
FDA Adverse Event
Injury
·ASAHI INTECC CO., LTD.·Product code DQX·October 20, 2010
LYNX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·December 19, 2012
a. Segmental Stem, Cemented, Straight, 100MM, 1 EACH; Model Numbers: CS-09100-03M, CS-10100-03M. b. Segmental Stem, Cemented, Straight, 120MM, 1 EACH. Model Numbers: CS-11120-03M, CS-13120-03M, CS-15120-03M, CS-17120-03M. Component. of ELEOS LIMB SALVAGE SYSTEM
FDA Enforcement
Class II
·Ongoing·Onkos Surgical, Inc.·June 4, 2025
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020