11 results
·
19ms
·
Sources: EU EUDAMED, US FDA
BIOPRO PROXIMAL FEMORAL ARTICULAR REPLACEMENT
FDA 510(k)
FDA Class 2
·Orthopedic
Arthrex®
FDA UDI
ARTHREX, INC.·00888867201743·DRILL INSERT, SINGLE GUIDE
AUTO MASH
FDA 510(k)
FDA Class 1
·Microbiology
C3 ANTISERUM CONTROL
FDA 510(k)
FDA Class 2
·Immunology
SYMBIQ SINGLE CHANNE
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·May 21, 2014
INSYNC SENTRY
FDA Adverse Event
Death
·MEDTRONIC MED REL, INC.·Product code NIK·November 10, 2010
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM
FDA Adverse Event
Death
·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code MCX·January 3, 2013
THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE
FDA Adverse Event
Malfunction
·THORATEC CORPORATION·Product code DSQ·September 30, 2025
HEARTMATE 3 VAD MODULAR CABLE
FDA Adverse Event
Malfunction
·THORATEC CORPORATION·Product code DSQ·January 25, 2024
EV3 Pipeline Flex Embolization Device with Flex Shield Technology
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