12 results
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19ms
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Sources: EU EUDAMED, US FDA
WHEEL-O-VATOR
FDA 510(k)
FDA Class 2
·Physical Medicine
Voluson
FDA UDI
GE Healthcare Austria GmbH & Co OG·00195278699824·Voluson Expert 20 BT24
BONE STAPLE(S)
FDA 510(k)
FDA Class 2
·Orthopedic
INTRADISCAL THERAPY TRAY
FDA 510(k)
FDA Class 2
·General Hospital
AUTOSOFT 30
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·August 8, 2024
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 10, 2013
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·February 4, 2014
EXTERNAL PADDLES
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·December 3, 2010
AUTOSOFT 30
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·August 8, 2024
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·May 2, 2025
Covidien Trellis-8 Peripheral Infusion System. Models CVT808015, CVT808025, CVT812015, and CVT812025. The following models are not offered for sale in the US: EVT808015, EVT808025, EVT812015, and EVT812025 Sterile EO. Product Usage: Intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
FDA Enforcement
Class I
·Terminated·Covidien·February 11, 2015
Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only. Models BVT608010V01, BVT608030V01, BVT612010V01, BVT612030V01, CVT808015, CVT808025, CVT812015, CVT812025, EVT808015, EVT808025, EVT812015, EVT812025, BVT808015, BVT808030, BVT812015, BVT812030, EUT808015, EUT808030, EUT812015, EUT812030. Product Usage: The Trellis 6 and Trellis 8 peripheral infusion system is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
FDA Enforcement
Class II
·Terminated·Medtronic Inc. Cardiac Rhythm Disease Management·April 8, 2015