18 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class)
FDA 510(k)
FDA Class 2
·Radiology
Mouthpiece, Disposable, 1.035" O.D., 2.625" Length
FDA UDI
A-M SYSTEMS, LLC·00817081024050·Mouthpiece, Disposable, 1.035" O.D., 2.625" Length
Needle Holder
FDA UDI
KATENA PRODUCTS, INC.·00841668108307·BARRAQUER NEEDLE HOLDER STRAIGHT W/ LOCK
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702441727·Elvarex Forte 3/Thigh High/Closed Toe, E-Versio...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04059993056415·ELVAREX FORTE 3/KNEE HIGH/PROFILE-CLOSED TOE-EL...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702616330·ELVAREX 2/KNEE HIGH/OPEN TOE-ELEPHANTIASIS-VERS...
II Ring Retractor
FDA UDI
Automated Medical Products Corp.·00810118342677·Round Ring Large 12.5”
GORE EMBOLIC FILTER
FDA 510(k)
FDA Class 2
·Cardiovascular
DC-6 DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
T:FLEX INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code LZG·July 12, 2021
YO Home Sperm Test
FDA UDI
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.·07290016650365·
Ascend
FDA UDI
ALPHATEC SPINE, INC.·00190376521244·16 mm CORE ENDPLATE, BAN 16 x 35 mm 0°
Ascend
FDA UDI
ALPHATEC SPINE, INC.·00190376521602·12 mm CORE ENDPLATE, BAN 16 x 35 mm 0°
Ascend
FDA UDI
ALPHATEC SPINE, INC.·00190376519012·12 mm CORE ENDPLATE, LAT 16 x 35 mm 0°
Ascend
FDA UDI
ALPHATEC SPINE, INC.·00190376519975·16 mm CORE ENDPLATE, LAT 16 x 35 mm 0°
V60 VENTILATOR
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, INC.·Product code MNT·October 10, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·June 11, 2013
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·July 15, 2011