14 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Atlantis® Abutments in Titanium
FDA 510(k)
FDA Class 2
·Dental
ELMED
FDA UDI
ELMED INCORPORATED·00842180134768·5 MM DIA., 33 CM, LAP. MONOPOLAR "J" HOOK ELECT...
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011250081200·ceraMotion® Zr Shoulder A, 20 g / dental cerami...
devemed
FDA UDI
devemed GmbH·04061644020461·Membrane positioning instrument "Buser"
2.0 / 2...
NEUWAVE Microwave Ablation System and Accessories
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CORE-SPORT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Reicodent
FDA UDI
devemed GmbH·04061644037308·Membr2.0 / 2.0 mmane positioning instrument "Bu...
Widex
FDA UDI
Widex A/S·05706069895049·WIDEX EVOKE ERB0 (Tan silk ) 100, RC coil, RIC 10
Widex
FDA UDI
Widex A/S·05706069896206·WIDEX EVOKE EBB3D (Tan silk ) 100, Telecoil, RC...
Widex
FDA UDI
Widex A/S·05706069896466·WIDEX EVOKE E-FS (Tan silk ) 100, Telecoil, RC ...
NON AC-POWERED PATIENT LIFT
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code FSA·September 15, 2011
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Death
·ZOLL MANUFACTURING CORPORATION·Product code MVK·November 7, 2014
CVC KIT: 3-LUMEN 7 FR X 60 CM
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code DQY·July 24, 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