20 results · 22ms · Sources: EU EUDAMED, 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