14 results · 21ms · Sources: EU EUDAMED, US FDA

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HardyDisk Aztreonam/Avibactam 30/20µg (AZA50)

FDA 510(k)
FDA Class 2 ·Microbiology

Darby Dental Supply, LLC

FDA UDI
DARBY DENTAL SUPPLY, LLC·00889813058176·STERILE CARBIDE BUR FG171 DARBY

Oticon

FDA UDI
Sbo Hearing A/S·05714464090532·OTICON JET 2 BTE PP C063

ESSENTIALS

FDA UDI
TOTAL RESOURCES INTERNATIONAL INC.·00020424016432·LOWE’S ESSENTIAL - HBC First Aid Kit 110 pcs. -...

OMNITECH FULGURATING ELECTRODE

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

Acryfree Denture Base Material and Biosens Denture Base Material

FDA 510(k)
FDA Class 2 ·Dental

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·March 17, 2020

QUADRA R FEMORAL STEMS

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·March 30, 2026

Z NAIL CMF 10.5 X 95 LAG SCR

FDA Adverse Event
Malfunction ·ZIMMER GMBH·Product code HSB·March 30, 2026

Z NAIL CMF 9.3MMX17.5CM 125L

FDA Adverse Event
Malfunction ·ZIMMER GMBH·Product code HSB·March 30, 2026

HEARTSTART MRX-EMS DEFIBRILLATOR

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·November 7, 2014

OT PING METER

FDA Adverse Event
Malfunction ·LIFESCAN INC.·Product code NBW·September 15, 2011

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Adverse Event
Injury ·BAXTER HEALTHCARE·Product code KDJ·July 26, 2013

Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

FDA Enforcement
Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013