10 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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POWERED WHEELCHAIR, MODEL FR168W
FDA 510(k)
FDA Class 2
·Physical Medicine
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033370·Baltic Denture System BDLoad BDLoad Lw6 PLSEbi...
CHEETAH I.V.D.S., MODEL 2002P
FDA 510(k)
FDA Class 2
·Cardiovascular
JAMSHIDI MARROW ACQUISITION CRADLE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 3, 2013
SECURE ACUTE CARE BED 3/01
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·March 22, 2011
INFINITI VISION SYSTEM
FDA Adverse Event
Injury
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·April 24, 2008
The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021