11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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T.A.G. Dental Implant System
FDA 510(k)
FDA Class 2
·Dental
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814299·GENUMEDI PT SILVER R VI
Novo Surgical Inc.
FDA UDI
NOVO SURGICAL, INC.·00842331128110·ingrown nail splitting scissors, 6" (15.2 cm)
MULTIPLE BIOPSY SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BEWELL, MODEL SC 20
FDA 510(k)
FDA Class 2
·Physical Medicine
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 6, 2014
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 3, 2013
AQUALINE S
FDA Adverse Event
Malfunction
·HAEMOTRONICS SPA·Product code FJK·June 29, 2011
SPINDLE FOR EVOLUTION
FDA Adverse Event
Malfunction
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code LXH·November 14, 2018
SPINDLE FOR EVOLUTION
FDA Adverse Event
Malfunction
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code LXH·January 16, 2020
Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021