15 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DEKA LOTUS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776305437·Hoke Osteotome 5 12" str 316" (4mm)
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780455820·Integra® Jarit® Hoke Osteotome, Straight
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011250281200·ceraMotion® Zr Incisal Value 2, 20 g / dental c...
TRANSPORT SERIES TRANSPORT CHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
StatStrip Glucose Hospital Meter
FDA 510(k)
FDA Class 2
·Clinical Chemistry
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·October 6, 2023
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 8, 2025
OT VERIO IQ METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 12, 2018
STYLUS MINI HIGH SPEED HANDPIECE
FDA Adverse Event
Malfunction
·DENTSPLY PROFESSIONAL·Product code EFB·November 6, 2014
SPRINT QUATTRO
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·September 15, 2011
PINNACLE PELVIC FLOOR REPAIR KITS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 26, 2013
Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·July 22, 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
Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026