20 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ONCENTRA PROSTATE 4.0
FDA 510(k)
FDA Class 2
·Radiology
Universal Needle Tips (Black)
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172001649·Dental material injection cannula, single-use
n/a
FDA UDI
HANS RUDOLPH, INC.·00874750006366·2600CB 2WAY NRBV W/BODY SALIVA
P&P marker for ATEC
FDA UDI
Noras MRI products GmbH·04251269202216·
DD tempMED
FDA UDI
Dental Direkt GmbH·EDDIK114201·DD tempMED are pre-colored dental milling blank...
DD tempMED
FDA UDI
Dental Direkt GmbH·EDDIK112201·DD tempMED are pre-colored dental milling blank...
AOS TIBIAL NAIL 12mm x 42.0cm
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665016376·
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776172213·Forcep Rochester-Ewald L
Probe
FDA UDI
ELLIQUENCE, LLC·00846338002206·
Best Medical International
FDA UDI
BEST MEDICAL INTERNATIONAL, INC.·00841365105869·
OPHIRA MINI SLING SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EMBOL-X ACCESS DEVICE/ AORTIC CANNULA, EMBOL-X SLIM ACCESSDEVICE/ AORTIC CANNULA, EMBOL-X GLIDE ACCESS DEVICE/ AORTIC CA
FDA 510(k)
FDA Class 2
·Cardiovascular
Gibralt
FDA UDI
Choice Spine, LP·00840996169417·GIBRALT,DRILL,FIXED,2.4X20
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 8, 2025
BD TRUCOUNT TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·July 13, 2021
SOLETRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·May 14, 2013
OT ULTRASMART METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 24, 2014
TOTALCARE BARIATRIC
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·April 28, 2011
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
Model Number L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025