12 results
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18ms
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Sources: EU EUDAMED, US FDA
URINARY DRAINAGE BAG 2D9017
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517821966·Interlock II Trial, 13x17x14mm 15° Stop
VELLAmini 5% Sodium Fluoride Varnish Bubble Gum Box 100
FDA UDI
Preventech·D024772113·VELLAmini 5% Sodium Fluoride Varnish Bubble Gum...
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011772113000·Intraoral latex elastics, medium, ø 3.2 mm
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011772113010·Intra-oral latex elastics, medium, ø 3.2 mm
ESTILUX UV SYSTEM
FDA 510(k)
FDA Class 2
·Dental
INTEGRA FLOWABLE WOUND MATRIX, MODEL FWD301
FDA 510(k)
FDA Unclassified
·Unknown
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 25, 2014
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·June 27, 2007
SOFTCLIX ® LANCET DEVICE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·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
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025