15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SENZZZZZ AWAY
FDA 510(k)
FDA Class 2
·Dental
NOVO Health Services, LLC
FDA UDI
NOVO HEALTH SERVICES, LLC·00810019801129·Towel, Circ NS
ARGEDENT 500 (5 dwt)
FDA UDI
ARGEN CORPORATION, THE·D818120176·Gold based noble metal
NOVO Health Services, LLC
FDA UDI
NOVO HEALTH SERVICES, LLC·00812564035639·Towel, Circ NS
Diversatek Healthcare
FDA UDI
DIVERSATEK HEALTHCARE, INC.·M7831201760·Endoscopy Basic Procedure Kit
EPOC READER, HOST
FDA Adverse Event
Malfunction
·EPOCAL INC.·Product code CGL·October 26, 2020
ONE TOUCH ULTRA
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·April 15, 2002
HDR MIAMI APPLICATOR
FDA 510(k)
FDA Class 2
·Radiology
ASCENSION ANKLE FUSION PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE APP)
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·May 3, 2024
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·March 10, 2023
SM104 MSERIES W5TH WHLOBS3/07
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·May 20, 2013
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code IOR·September 25, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 10, 2011
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