11 results
·
31ms
·
Sources: EU EUDAMED, US FDA
MENTOR TONO-PEN 3
FDA 510(k)
FDA Class 2
·Ophthalmic
IC MICROASSAY
FDA 510(k)
FDA Class 2
·Immunology
RHEUMAGEN CRP T-CONTROL
FDA 510(k)
FDA Class 2
·Immunology
CER BIOLOXD OPTION HD 28MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LPH·December 17, 2020
G7 DUAL MOBILITY LINER
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·August 27, 2020
VIVACIT-E DM LINER 28 X 46MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·December 23, 2020
VIVACIT-E DM BEARING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·August 27, 2020
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code PAH·February 15, 2013
JOSTENT GRAFTMASTER
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MAF·January 19, 2011
FOUNDATION HIP
FDA Adverse Event
Injury
·ENCORE MEDICAL, L.P.·Product code KWA·July 29, 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