14 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip
FDA 510(k)
FDA Class 2
·Clinical Chemistry
K152468
FDA UDI
Shenzhen Vistar Medical Supplies Co.,Ltd.·96973521874184·Reusable NIBP cuff,Thigh,single tube, HP connector
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704284874·GELPI RETRACTOR 7 1/2" SHARP POINTS
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·14026704921024·
CALYPSO SYSTEMS WITH DYNAMIC EDGE GATING
FDA 510(k)
FDA Class 2
·Radiology
SECRMARK BIOPSY SITE MARKING SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
FOGARTY
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES PR·Product code MJN·March 24, 2025
PROGRAMMING SOFTWARE
FDA Adverse Event
Malfunction
·CYBERONICS·Product code LYJ·June 8, 2013
COLLEAGUE PRE-P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 7, 2011
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·October 8, 2014
VENATECH CONVERTIBLE
FDA Adverse Event
Malfunction
·B.BRAUN MEDICAL SAS·Product code DTK·January 5, 2018
ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014
OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021