10 results
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18ms
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Sources: EU EUDAMED, US FDA
WEDGES, RETAINING, MATRIX
FDA 510(k)
FDA Class 1
·Dental
CoRoent
FDA UDI
Nuvasive, Inc.·00887517822123·Interlock II Trial, 14x17x14mm 30° Stop
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011772314010·Intraoral non-latex elastics, medium, ø 4.8 mm
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011772314000·Intraoral non-latex elastics, medium, ø 4.8 mm
Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D)
FDA 510(k)
FDA Class 2
·Ophthalmic
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WITH ALOE VERA, GREEN COLOR
FDA 510(k)
FDA Class 1
·General Hospital
SPRINTER LEGEND RX
FDA Adverse Event
Malfunction
·MEDTRONIC MEXICO·Product code LOX·April 25, 2014
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)
FDA Adverse Event
Malfunction
·ALLERGAN·Product code LTI·October 2, 2012
DEPUY ASR XL FEM IMP SZ 49
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