8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Surgical face mask
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Medtronic Reusable Instruments
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994503442·INSERTER 1220777 OUTER SHFT PEEK PREVAIL
BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM WITH BI-FLEX
FDA 510(k)
FDA Class 2
·Anesthesiology
VeriFixx Small Bone Implant
FDA 510(k)
FDA Class 2
·Orthopedic
HI PWR DISPOSBL GRNDING PAD
FDA Adverse Event
Malfunction
·COVIDIEN LP (VALLEYLAB)·Product code ODR·October 31, 2008
VANGUARD DCM CR TIBIAL BEARING 14MM X 79/83MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·August 23, 2011
COYOTE? ES
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LIT·July 11, 2013
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018