12 results
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27ms
·
Sources: EU EUDAMED, US FDA
IONOMETER E-HK AND ACCESSORIES
FDA 510(k)
FDA Class 2
·Hematology
DESS dental smart solutions
FDA UDI
TERRATS MEDICAL SL.·08435457210580·Internal Hex "Click"
CancelleX Porous Titanium Lumbar Interbody Device
FDA 510(k)
FDA Class 2
·Orthopedic
TACAHE PC1350 POWER WHEELCHAIR
FDA 510(k)
FDA Class 2
·Physical Medicine
HX2 TEMPERATURE MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DWC·October 15, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 30, 2014
12/14 ARTICUL 40MM M SPEC+8.5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JDI·December 19, 2012
EVOLUT FX DCS
FDA Adverse Event
Malfunction
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·July 18, 2025
ANTI-SIPHON PCA EXTENSION SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - AIBONITO·Product code FRN·February 4, 2011
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
Pipeline Flex Embolization Device
FDA Enforcement
Class I
·Ongoing·Micro Therapeutics Inc,·September 15, 2021
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020