7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STRYKER ORTHOPOWER 90 & ORTHOPOWER 90 SYSTEM II
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Premium Plus Disposable Barrier Sleeve
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INSIGHT DISCOVERY
FDA 510(k)
FDA Class 2
·Physical Medicine
CARELINK
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code KRG·June 10, 2014
DRILL 3334800 VISAO 80K HANDPIECE
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED, INC.·Product code ERL·December 10, 2012
STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP.
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND GMBH·Product code DWA·June 17, 2015
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022