11 results
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18ms
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Sources: EU EUDAMED, US FDA
FIAX C4 ASSAY
FDA 510(k)
FDA Class 2
·Immunology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517821973·Interlock II Trial, 14x17x14mm 15° Stop
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011772114000·Intraoral latex elastics, medium, ø 4.8 mm
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011772114010·Intra-oral latex elastics, medium, ø 4.8 mm
Zimmer Natural Nail System
FDA 510(k)
FDA Class 2
·Orthopedic
IMPULSE 6000D/7000DP
FDA 510(k)
FDA Class 2
·Cardiovascular
M2A-MAGNUM PF CUP 48ODX42ID
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·April 25, 2014
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·June 27, 2007
OT ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·October 4, 2012
Model 055: Thermophore Classic, Professional Quality, Deep-Heat Therapy, Model 055 Large 14' x 27", Model 056: Thermophore Classic, Professional Quality Deep-Heat Therapy, Model 056 Medium 14" x 14", Model 077: Thermophore Classic Professional Quality Deep-Heat Therapy, Model 077 Petite 4"x 17",Model 095: Thermophore Classic, Professional Quality Deep-Heat Therapy, Model 095 Large 14" x 27 Model 096: Thermophore Classic, Professional Quality Deep-Heat therapy Model 096, Medium, 14" x 14" Model 097: Thermophore Classic, Professional quality Deep-Heat Therapy, Model 097 , Petite, 4" x 17", Model 255: Thermophore Classic Plus, Professional Quality Deep-Heat Therapy, Model 255 Large,14" x 27", Model 256: Thermophore Classic Plus Professional Quality Deep-Heat Therapy, Model 256, Medium, 14" X 14 Model 277: Thermophore Classic Plus Professional Quality Deep-Heat Therapy, Model 277, Petite , 4" x 17" Used for the temporary relief of joint and muscle pain.
FDA Enforcement
Class II
·Terminated·Battle Creek Equipment Co.·November 9, 2016
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020