14 results
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37ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Disposable Distal Attachment D-201 Series
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776305499·Hoke Osteotome 5 12" cvd 58" (16mm)
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780455936·Integra® Jarit® Hoke Osteotome, Curved
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011250296030·ceraMotion® Paste 3D Dentin dark / dental ceram...
ELEOS
FDA Adverse Event
Injury
·ONKOS SURGICAL·Product code KRO·October 3, 2025
ECLIPSE TREATMENT PLANNING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
Biodenta Customized Abutment-Hybrid
FDA 510(k)
FDA Class 2
·Dental
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·March 29, 2022
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·April 15, 2022
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·October 10, 2022
HEARTSTART SLA BATTERY
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·November 6, 2014
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·July 26, 2013
OT VERIO2 METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 25, 2015
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