9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODEL K210 AND K211 FLUIDOTHERAPY UNITS
FDA 510(k)
FDA Class 2
·Physical Medicine
Scio Four, plus
FDA UDI
Drägerwerk AG & Co. KGaA·04048675429319·
Rongeur
FDA UDI
KATENA PRODUCTS, INC.·00841668108499·KERRISON RONGEUR SIZE 2
TESLA GUARD, MODEL EFT G04
FDA 510(k)
FDA Class 2
·Cardiovascular
ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)
FDA 510(k)
FDA Class 2
·Neurology
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 17, 2014
BRANEMARK SA TAPERED SLOT SCREW
FDA Adverse Event
Injury
·ATTACHMENTS INTL., INC.·Product code DZE·October 16, 2010
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·December 13, 2012
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