12 results
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27ms
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Sources: EU EUDAMED, US FDA
MEROCEL REINFORCED SILICONE SHEETS
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Barco
FDA UDI
Barco NV·05415334050082·MDSC-8532 SSTF M2
DeBakey Aortic Aneurysm Clamps
FDA UDI
KOROS U.S.A., INC.·10840199540133·DeBakey Aortic Aneurysm Clamps 34cm 13-1/2"
iNSitu™ Hip System
FDA UDI
NEXTSTEP ARTHROPEDIX, LLC·00816127023231·Calcar Planer Adaptor
Arx
FDA UDI
Life Spine, Inc.·00190837126032·
Arx
FDA UDI
Life Spine, Inc.·00190837075491·Polyaxial Non-Cannulated Screw, 9.5x 30mm
Disposable Stone Retrieval Balloon Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LYME IGM ELISA TEST
FDA 510(k)
FDA Class 2
·Microbiology
SPRINT FIDELIS
FDA Adverse Event
Injury
·MPRI·Product code LWS·February 9, 2013
SUPERA PERIPHERAL SELF-EXPANDING STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code NIP·July 23, 2014
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·January 7, 2011
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