10 results
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26ms
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Sources: EU EUDAMED, US FDA
X-RAY CO-ORDINATOR
FDA 510(k)
FDA Class 1
·Radiology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517822116·Interlock II Trial, 13x17x14mm 30° Stop
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011772313010·Intraoral non-latex elastics, medium, ø 3.2 mm
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011772313000·Intraoral non-latex elastics, medium, ø 3.2 mm
REAGENT LDH-L, ENZYME
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AMPLATZER TORQVUE DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
NEUROMONITOR BASIC KIT
FDA Adverse Event
Injury
·Product code GWM·April 25, 2014
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)
FDA Adverse Event
Malfunction
·ALLERGAN·Product code LTI·October 2, 2012
ASR ACETABULAR IMP 50
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code JDI·July 23, 2010
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