22 results · 28ms · Sources: EU EUDAMED, US FDA

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ASSURE PLATINUM AND GLUCOCARD VITAL BLOOD GLUCOSE MONITORING SYSTEMS

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

LEONE SPA

FDA UDI
LEONE SPA·08033707065630·INTRAORAL ELASTICS 2,5 oz 1/8" brown

ConMed

FDA UDI
Provision·B504OM50911020·

LEONE SPA

FDA UDI
LEONE SPA·08033707065739·INTRAORAL ELASTICS 6,5 oz 3/16" green

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450217641·

General Instrument

FDA UDI
ALPHATEC SPINE, INC.·00840180507209·Cup Curette, Up-Angled, Medium

PARSET PRIMARY SET WITH CHECK VALVE, MODEL A10002E

FDA 510(k)
FDA Class 2 ·General Hospital

ANTERIOR CRUCIATE LIGAMENT (ACL) INSTRUMENT SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

WAVEWRITER ALPHA?

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·September 10, 2025

ACCESSORIES

FDA Adverse Event
Malfunction ·ABBOTT VASCULAR INC.·Product code DQX·March 20, 2025

BIPOLAR INSERT CEV633-1A 350MM BOTELLA

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED INSTRUMENTATION S.A.S. LE PAVILLON·Product code GEI·August 29, 2013

PASSPORT V MONITOR

FDA Adverse Event
Malfunction ·MINDRAY DS USA, INC.·Product code MHX·April 30, 2013

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 16, 2014

DEXTRUS 4136

FDA Adverse Event
Other ·BIOTRONIK SE & CO. KG·Product code NVZ·May 3, 2011

INDEFLATOR

FDA Adverse Event
Malfunction ·ABBOTT VASCULAR INC.·Product code MAV·February 27, 2024

INDEFLATOR

FDA Adverse Event
Malfunction ·ABBOTT VASCULAR INC.·Product code MAV·March 21, 2024

NEOPUFF INFANT RESUSCITATOR

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTL·March 28, 2013

TUBE CEV649-5B DIA 5MM 350MM

FDA Adverse Event
Malfunction ·INTEGRA MICROFRANCE S.A.S.·Product code GEI·March 23, 2026

HANDLE CEV10395R DIA 5MM ANG W/O RATCHET

FDA Adverse Event
Malfunction ·INTEGRA MICROFRANCE S.A.S.·Product code GEI·March 23, 2026

INSERT CEV625-1 FENESTRATED 350MM

FDA Adverse Event
Malfunction ·INTEGRA MICROFRANCE S.A.S.·Product code GEI·March 30, 2026