11 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SKOUT® system
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Sonic
FDA UDI
Sbo Hearing A/S·05714464029068·SONIC RADIANT 100 MNR T BL/DG DEMO
Cooley Pediatric Occlusion Clamp 14cm
FDA UDI
Geister Medizintechnik GmbH·04057034062005·Cooley Pediatric Occlusion Clamp 14cm
STANDARD THERMOMETER
FDA 510(k)
FDA Class 2
·General Hospital
ELIXBO PM545
FDA 510(k)
FDA Class 2
·Radiology
BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code FOZ·February 28, 2022
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 20, 2025
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·November 6, 2014
ACRYSOF RESTOR
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD./HUNTINGTON·Product code MFK·August 12, 2011
ENTERRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LNQ·July 16, 2013
CODMAN Disposable Perforator 11mm. Cranial Perforator.
FDA Enforcement
Class I
·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·November 12, 2025