12 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Disposable Coaxial Biopsy Needle
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NA
FDA UDI
Synthes GmbH·10886982152886·2.4MM LOCKING SCREW SLF-TPNG WITH STARDRIVE REC...
GLOBAL ADVANTAGE
FDA UDI
DEPUY (IRELAND)·10603295088523·GLOBAL ADVANTAGE COOKIE CUTTER 10mm
GLOBAL ADVANTAGE
FDA UDI
DEPUY (IRELAND)·10603295088530·GLOBAL ADVANTAGE OSTEOTOME COLLAR SIZE 10/12
MODIFICIATION TO: BILIARY WALLSTENT ENDOPROSTHEIS WITH MONORAIL DELIVERY SYSTEM, MODEL 71-XXX
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SLEEPSTRIP II
FDA 510(k)
FDA Class 2
·Anesthesiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 23, 2024
LAMITRODE 88C
FDA Adverse Event
Injury
·ST JUDE MED- NEUROMODULATION·Product code GZB·October 24, 2014
HEARTSTART MRX - EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE - ANDOVER·Product code MKJ·July 12, 2011
GYNECARE TVT EXACT CONTINENCE SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·July 9, 2013
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023
BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021