11 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DANEKSCOPE AND ACCESSORIES
FDA 510(k)
FDA Class 2
·Orthopedic
SIGMA PACE EXTERNAL PACEMAKER ANALYZER MODEL #1000
FDA 510(k)
FDA Class 2
·Cardiovascular
PILOT SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
BD PLASTIPAK LUER-LOK SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·March 13, 2020
SINGLE EXTENSION
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION·Product code LGW·November 19, 2010
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·January 11, 2013
INGENIO
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 3, 2014
THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORP.·Product code GEI·July 30, 2020
BD PLASTIPAK LUER-LOK SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·March 5, 2020
VITEK® 2 GN TEST KIT
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC.·Product code LQM·September 17, 2018
Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024