13 results
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19ms
·
Sources: EU EUDAMED, US FDA
MASK, SURGICAL, DISP
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Micro Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR77705131·Micro Sprint Bracket McLaugh/Benn/Trev. .018" m...
The Orthodontic Store
FDA UDI
Young Innovations, Inc.·00843471184059·.022 U/L Std. Sngl Weld Sz#13
Micro Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR77705131001·Micro Sprint Bracket McLaugh/Benn/Trev. .018" m...
Micro Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR77705130101·Micro Sprint Bracket McLaugh/Benn/Trev. .018" m...
Micro Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR77705130051·Micro Sprint Bracket McLaugh/Benn/Trev. .018" m...
HAMILTON-G5
FDA 510(k)
FDA Class 2
·Anesthesiology
MAUSER PG II Sharps Container
FDA 510(k)
FDA Class 2
·General Hospital
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·June 19, 2007
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 5, 2014
GYNECARE MORCELLEX* TISSUE MORCELLATOR
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code HET·October 3, 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