8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NATURAL-KNEE II CONSTRAINED KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
GRYPHON BR AND HEALIX BR ANCHORS
FDA 510(k)
FDA Class 2
·Orthopedic
GRAM NEGATIVE (GN) BROTH, PRODUCT #T3038
FDA 510(k)
FDA Class 1
·Microbiology
RIATA PASSIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·February 21, 2013
CL NON-DEHP CONTINU-FLO SET10 DPM, 110", 3 CL SITES
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FPA·January 30, 2011
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE REHABILITATION EQUIP·Product code CAW·August 1, 2014
Hand Pack, part number AMS3640 Hand Pack, part number AMS4213(A Hand Pack, part number AMS4311(A Hand Pack, part number AMS5343 Hand Pack., part number PSS1843(A
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
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