10 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SURGICAL INSTRUMENT TRAY
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ReLine
FDA UDI
Nuvasive, Inc.·00195377072986·RELINE C Ti Rod, 4.0x25mm Pre Bent
Solstice Occipito-Cervico-Thoracic System
FDA UDI
Life Spine, Inc.·00190837024901·SOLSTICE Polyaxial Screw Assembly 4.0mm x 25mm
Calibration Solution
FDA UDI
Radiometer Medical ApS·05700699440259·S1730 Calibration Solution 2 200 mL, for ABL7XX
CONTOUR CHAIR LOUNGE W/OPTIIONAL HEAT & MASSAGE
FDA 510(k)
FDA Class 2
·Physical Medicine
Argo Knotless GENESYS Anchor
FDA 510(k)
FDA Class 2
·Orthopedic
PINNACLE MTL INS NEUT36IDX50OD
FDA Adverse Event
Injury
·DEPUY INTL., LTD. ¿ REG. # 8010379·Product code KWA·February 5, 2013
GREENLIGHT HPS LASER SYSTEM
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER- SILICON VALLEY·Product code GEX·December 29, 2010
RIATA ST PASSIVE FIXATION
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·July 18, 2014
S1730 Calibration Solution 2, 200 mL, packed in single unit plastic bottles, REF 944-025, used with ABL700 Series Blood Gas Analyzers.
FDA Recall
Terminated
·Radiometer America Inc·Product code CHL·October 31, 2005