11 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NATURAL-KNEE(R)/APOLLO(TM) KNEE
FDA 510(k)
FDA Class 2
·Orthopedic
Ophthalmic Hook
FDA UDI
KATENA PRODUCTS, INC.·00841668103968·KUGLEN LENS MANIPULATOR ANGLED ROUND
Arthrex®
FDA UDI
ARTHREX, INC.·00888867139541·ARTHREX ECLIPSE HUMERAL HEAD, 55/23
FLO-GARD(R) 6301
FDA 510(k)
FDA Class 2
·General Hospital
ITC BUNJI PLATINUM EMBOLIZATION COIL
FDA 510(k)
FDA Class 2
·Neurology
KUGLEN LENS MANIPULATOR ANGLED ROUND
FDA Adverse Event
Malfunction
·KATENA PRODUCTS INC.·Product code HND·April 24, 2025
STERRAD NX STERILIZER
FDA Adverse Event
Malfunction
·ADVANCED STERILIZATION PRODUCTS·Product code MLR·December 22, 2010
SM304 M-SERIES W/ZOOM
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code INK·January 4, 2013
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - HAINA, SAN CRISTOBAL·Product code BRZ·July 15, 2014
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