7 results · 19ms · Sources: EU EUDAMED, US FDA

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KELOCOTE

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

MALIS IRRIGATION SYSTEM

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

CEDIA(TM) PHENOBARBITAL ASSAY

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

CAPSUREFIX NOVUS

FDA Adverse Event
Malfunction ·MPRI·Product code DTB·February 11, 2013

AML 10.5 MMA 6.3 5/8 STD 12/14

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·January 5, 2011

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·July 24, 2014

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