14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Syngo.Via RT Image Suite
FDA 510(k)
FDA Class 2
·Radiology
Bernafon
FDA UDI
Bernafon AG·05711584087398·ZR1, KIT 312 NFM L BE ZERENA 1
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776200039·LLETZ AUVARD SPEC LBS ET
CADD CASSETTE 100ML W/FLOWSTOP
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code LHI·March 17, 2022
SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
DIGITAL IMPRESSION SYSTEM FOR ORTHODONTIC USE
FDA 510(k)
FDA Class 2
·Dental
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 2, 2024
CADD MEDICATION CASSETTES
FDA Adverse Event
Malfunction
·ST PAUL·Product code FPA·April 4, 2022
RESTORE ADVANCED RECHARGEABLE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·October 7, 2008
EON
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 20, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011
2.4/3.0MM CRUCIFORM SCRWDRVR BLADE WITH HEX COUPLING
FDA Adverse Event
Malfunction
·SYNTHES BRANDYWINE·Product code HXX·April 2, 2013
TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems·October 10, 2018
Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021