42 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Elite SPK, Compasso, Elite SPK Kit
FDA 510(k)
FDA Class 2
·Orthopedic
Polysorb
FDA UDI
Covidien LP·10884521176812·Meniscal Stapler Handle
BioHorizons
FDA UDI
BIOHORIZONS IMPLANT SYSTEMS, INC·00847236001803·The External System Surgical Kit
EZ-Fill Root Canal Cement
FDA UDI
ESSENTIAL DENTAL SYSTEMS, INC.·00766054000136·Root Canal Cement Powder Jar/Gel Tube with Bi-D...
TALOS®-C HA
FDA UDI
MEDITECH SPINE, LLC·B167521605000·
Apelo® / Apelo® MIS
FDA UDI
ATLAS SPINE, INC.·M68111001605000·5.5mm x 500mm MIS Contoured Rod
Vusion CS Plus
FDA UDI
Ortho Development Corporation·00822409025473·16 mm x 5 mm x Parallel
PSL CLASSIC SLIT LAMP
FDA 510(k)
FDA Class 2
·Ophthalmic
SPEEDY ORTHODONTIC SCREW
FDA 510(k)
FDA Class 2
·Dental
T:SLIM G5 SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OYC·September 10, 2018
T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·September 11, 2020
T:FLEX INSULIN DELIVERY SYSTEM
FDA Adverse Event
Injury
·TANDEM DIABETES CARE·Product code LZG·March 3, 2020
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·November 14, 2022
ECSTASY ENZYME IMMUNOASSAY, CATALOG # 0160 (500 TEST KIT), CATALOG # 0161 (5000 TEST KIT)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
INFINION CX
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 10, 2023
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Injury
·TANDEM DIABETES CARE·Product code QFG·February 16, 2022
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 6, 2024
Widex
FDA UDI
Widex A/S·05706069724592·Widex UNIQUE U-CIC-M (Light beige S-440 )
Widex
FDA UDI
Widex A/S·05706069724639·Widex UNIQUE U-CIC-M (Clay brown S-440 )
Widex
FDA UDI
Widex A/S·05706069563177·Widex UNIQUE U-CIC-M (Clay brown )