15 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Gold Anchor
FDA 510(k)
FDA Class 2
·Radiology
Vitique
FDA UDI
DMG Chemisch-Pharmazeutische Fabrik GmbH·EDMG2130531·Water soluble glycerin-free Try-in-paste for Ve...
RIGIDFIX
FDA UDI
Medos International Sàrl·10886705023387·RIGIDFIX CURVE Cross Pin System Instrumentation...
BIPAP A 30 VENTILATORY SUPPORT SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
MODIFICATION TO NANMA NON-ADJUSTABLE CONSTRICTION RING
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BIPAP A30-S SILVER
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code MNS·September 25, 2024
BIPAP A30, SILVER
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code MNS·September 25, 2024
BIPAP A30
FDA Adverse Event
Death
·RESPIRONICS, INC.·Product code MNS·September 13, 2023
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 16, 2011
ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code NIU·October 24, 2014
EASYTRAK 2
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code OJX·July 9, 2013
BD SYRINGE 5ML LL TIP BULK CONVENIENCE PAK
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMF·February 14, 2025
BD SYRINGE 5ML LL TIP BULK CONVENIENCE PAK
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMF·February 18, 2025
BIPAP A30-S SILVER
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code MNS·September 25, 2024
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023