11 results
·
22ms
·
Sources: EU EUDAMED, US FDA
DANTEC MONOPOLAR LUMEN ELECTRODE (13R18 AND 13R19)
FDA 510(k)
FDA Class 2
·Neurology
BASE
FDA UDI
Nuvasive, Inc.·00887517700520·BASE Guide, N
Masimo MightySat Rx Fingertip Pulse Oximeter
FDA 510(k)
FDA Class 2
·Cardiovascular
AQUINOX
FDA 510(k)
FDA Class 2
·Anesthesiology
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·April 29, 2016
DEPUY ASR XL FEM IMP SIZE 46
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·February 8, 2013
COOL PATH DUO 7F, 1304-CP2-7-1.5(5)-L1-TE4BE1AB
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL·Product code OAD·December 14, 2010
BLAZER PRIME® XP
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - COSTA RICA (HEREDIA)·Product code OAD·July 22, 2014
LARGE EX-FIX 11MM CRBN FBR ROD 250MM / MR-CONDITIONAL
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018
LARGE EX-FIX 11MM CRBN FBR ROD 300MM / MR-CONDITIONAL
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018
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