11 results
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34ms
·
Sources: EU EUDAMED, US FDA
MEDICAL EXAMINATION LIGHTS
FDA 510(k)
FDA Class 1
·General Hospital
Crimpable Stop
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746147159·ARCH STOP CRIMPABLE 2MM 025 ROUND 100/PKG
NAR Kit
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209105847·KIT, INDIVIDUAL WITH CG - BLK
OOCYTE RETRIEVAL NEEDLE SET, MODELS 917-IH AND 917-SH
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Contour Next Control Solution
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CONTOUR® NEXT
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code JJX·September 4, 2025
OPTIFLUX 180NRE DIALYZER FINISHED ASSY.
FDA Adverse Event
Malfunction
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FJI·April 22, 2014
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·October 4, 2010
PRECISE PRO RX CAROTID STENT SYSTEM
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code NIM·November 29, 2012
CONTOUR® PLUS
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code JJX·February 20, 2025
GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·January 19, 2022