14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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