22 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MEDLINE STOPCOCK AND MANIFOLD
FDA 510(k)
FDA Class 2
·Cardiovascular
Chemosite
FDA UDI
Covidien LP·10884521099050·Line Extension Set
ArgenIs
FDA UDI
ARGEN CORPORATION, THE·D818120069·Dental prosthesis/implant abutment screw
A non...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694002684·Medium 2 x 4 Hole Quad Plate
OsteoMed
FDA UDI
OSTEOMED LLC·00845694047562·Medium 2 x 4 Hole Quad Plate, Sterile
CADD CASSETTE 100ML W/FLOWSTOP
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code LHI·March 2, 2022
OsteoMed
FDA UDI
OSTEOMED LLC·00845694063616·1.2 System Hole 2 x 4 Quad Plate Sterile Qty 2
MEDTRONIC MIDA REX LEGEND SYSTEM, MIDAS REX LEGEND PNEUMATIC HIGH SPEED SYSTEM OR LEGEND SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
JOURNEY UNICONDYLAR TIBIAL BASEPLATES
FDA 510(k)
FDA Class 2
·Orthopedic
Widex
FDA UDI
Widex A/S·05706069794397·Widex EVOKE E-FP (Summer gold ) 220, Telecoil, ...
Widex
FDA UDI
Widex A/S·05706069807301·Widex EVOKE E-FM (Summer gold ) 220, RC coil
Widex
FDA UDI
Widex A/S·05706069818086·Widex UNIQUE U-FP (Summer gold ) 220, Telecoil,...
Widex
FDA UDI
Widex A/S·05706069817737·Widex UNIQUE U-FM (Summer gold ) 220, RC coil
Widex
FDA UDI
Widex A/S·05706069817140·Widex UNIQUE U-FA (Summer gold ) 220, Telecoil,...
Widex
FDA UDI
Widex A/S·05706069806236·Widex EVOKE E-FA (Summer gold ) 220, Telecoil, ...
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 20, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·September 25, 2014
LIFEPAK 20 DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code LDD·August 15, 2008
MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-000008 with software
FDA Enforcement
Class II
·Ongoing·Auris Health, Inc·February 25, 2026
Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format) Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.) Track interproximal decay progression over time Patient education tool
FDA Enforcement
Class II
·Terminated·GA Industries·May 6, 2015