16 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NewTom VGi evo
FDA 510(k)
FDA Class 2
·Radiology
Masel
FDA UDI
Ortho Organizers, Inc.·00190707040871·Choice™ Three Prong Bending Pliers
ProLift
FDA UDI
Life Spine, Inc.·00190837105778·Static Expandable Cage Trial, 12mm x 28mm x 7mm...
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B167311516120·
TALOS®-A
FDA UDI
SpineArt SA·07640375237927·TALOS®-A (HA) PEEK PLANAR, SYMMETRIC IBFD D28 ...
TALOS® HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B167321516120·
DIGITAL RETINAL CAMERA
FDA 510(k)
FDA Class 2
·Ophthalmic
ZEN CORDLESS PROPHY SYSTEM
FDA 510(k)
FDA Class 1
·Dental
BD VACUTAINER
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code JKA·October 16, 2007
BD PYXIS¿ MEDSTATION¿ ES
FDA Adverse Event
Malfunction
·CAREFUSION 303, INC.·Product code BRY·November 26, 2025
ILAB? POLARIS MULTI-MODALITY GUIDANCE SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQK·May 14, 2026
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 8, 2014
VIRTUOSO DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·June 7, 2013
OUTLOOK
FDA Adverse Event
Malfunction
·B. BRAUN MEDICAL, INC.·Product code FRN·June 24, 2011
BD PYXIS¿ MEDSTATION¿ ES
FDA Adverse Event
Malfunction
·CAREFUSION 303, INC.·Product code BRY·May 4, 2026
Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·April 9, 2014