15 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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StrataMR Valves and Shunts
FDA 510(k)
FDA Class 2
·Neurology
Bernafon
FDA UDI
Bernafon AG·05711583025568·CL100 ITCW, WL R BE CELEBRATE 100
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702450453·ELVAREX 2/THIGH HIGH/CLOSED TOE-ELEPHANTIASIS-V...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702898682·ELVAREX FORTE 3/KNEE HIGH/SLANT-OPEN TOE-ELEPHA...
II Ring Retractor
FDA UDI
Automated Medical Products Corp.·00810118341472·Malleable Retractor 4" x 12" with Protective Edge
RADIFOCUS GLIDEWIRE M
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·January 22, 2018
PANA-SPRAY
FDA 510(k)
FDA Class 1
·Dental
LIPID CONTROLS; MULTI- ANALYTE CONTROL; MULTI-ANALYTE CALIBRATION VERIFICATION MATERIALS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CADD CLEO INFUSION SET
FDA Adverse Event
Malfunction
·ICU MEDICAL MANUFACTURING S.A. DE C.V.·Product code FPA·February 20, 2026
PULSE-GENERATOR, PACEMAKER, IMPLANTABLE
FDA Adverse Event
Death
·MEDTRONIC, INC.·Product code LWS·October 8, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·June 7, 2013
ACTIVA RC
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code MHY·June 22, 2011
2.7MM LOCKING SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 12MM
FDA Adverse Event
Injury
·SYNTHES USA·Product code HRS·February 8, 2016
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021