13 results
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27ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CADENCE DOPPLER ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Monolith
FDA UDI
Nuvasive, Inc.·00887517677303·Monolith Core, Ø14x41mm
INCOGNITO
FDA UDI
Fempro Consumer Products ULC·00069207914411·PANTILINER LONG UNSCENTED 80 CT
Air Relax, Compressible Limb Sleeve System (Model: AR-1.0, AR-2.0)
FDA 510(k)
FDA Class 2
·Physical Medicine
SYNERGETICS ADJUSTABLE GAS PRESSURIZED INFUSION (AGPI) TUBE SET
FDA 510(k)
FDA Class 2
·General Hospital
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code FMT·April 30, 2026
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code FMT·December 3, 2025
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code FMT·October 16, 2025
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·March 6, 2013
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·August 8, 2014
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER CORP., MEDICAL DIV.·Product code FNL·January 27, 2011
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·November 5, 2025
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026