12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SurgTech Bipolar Head System
FDA 510(k)
FDA Class 2
·Orthopedic
PIVOX™ Oblique Lateral Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00763000878504·TRIAL 2173455 O25 IB 20MM 18 DEG 14X55
PIVOX™ Oblique Lateral Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169600089·TRIAL 2173455 O25 IB 20MM 18 DEG 14X55
Cancellous Screw, Cannulated
FDA UDI
I.T.S. GmbH·09120034308307·Cancellous Screw, Cannulated, D=7,3mm, L=55mm,
Sklar®
FDA UDI
SKLAR CORPORATION·10649111084980·COLLER FCP STR 5 1/2"
ATRAMAT
FDA UDI
Internacional Farmacéutica, S.A. de C.V.·07500142068775·ATRAMAT SILK SURGICAL SUTURE BLACK USP 4-0 EP 1...
E-VAC
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SPECTRA LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - AIBONITO·Product code FPB·June 17, 2013
UNICEL® DXC 800 SYNCHRON® CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·July 23, 2011
INRATIO
FDA Adverse Event
Injury
·HEMOSENSE, INC.·Product code JPA·September 23, 2008
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