11 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Philips iCT CT System
FDA 510(k)
FDA Class 2
·Radiology
SMOOTH STEINMANN PINS, DOUBLE END TROCAR POINT
FDA UDI
Biomet Orthopedics, LLC·00887868016752·
APPLIANCE, FIXATION, SPINAL INTERLAMINAL
FDA Adverse Event
Injury
·SYNTHES USA·Product code KWP·March 31, 2016
VITROS TROPONIN I ES ASSAY, INCLUDING REAGENT PACK, CALIBRATORS AND RANGE VERIFIERS, MODELS 680 2301, 2302 AND 2303
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
PURITAN BENNETT 980 SERIES VENTILATOR
FDA Adverse Event
Malfunction
·MEDTRONIC/COVIDIEN·Product code CBK·September 17, 2025
IMPAX CV REPORTING
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP.·Product code LLZ·June 11, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 15, 2011
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·September 16, 2008
SKINTACT
FDA Adverse Event
Injury
·LEONHARD LANG GMBH·Product code GEI·January 25, 2022
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