15 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Power Wheelchair (W5538)
FDA 510(k)
FDA Class 2
·Physical Medicine
exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular Graft
FDA 510(k)
FDA Class 2
·Cardiovascular
Pressure Right, Single-Use, Disposable, Acupressure, Pressure-Sensitive Wrist Strip
FDA 510(k)
FDA Unclassified
·Unknown
CERENOVUS ENTERPRISE
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code NJE·April 23, 2025
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·November 2, 2023
HEMOSPHERE ALTA
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code QAQ·November 18, 2025
HEMOSPHERE ALTA
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code QAQ·August 20, 2025
HEMOSPHERE ALTA
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code QAQ·November 18, 2025
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·November 11, 2014
DURATA STS OPTIM ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 10, 2011
COMBINATION WRENCH Ø11
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HXC·July 23, 2013
HEMOSPHERE ALTA
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code QAQ·November 18, 2025
CERENOVUS ENTERPRISE
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code NJE·May 5, 2025
PROWLER SELECT
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRA·April 23, 2025
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024