14 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ARTHRO-SURGIMAT
FDA 510(k)
FDA Class 2
·Orthopedic
P.F.C. SIGMA
FDA UDI
DEPUY (IRELAND)·10603295241133·P.F.C. SIGMA TIBIAL INSERT ROTATING PLATFORM ST...
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123083·K-WIRE - DOUBLE TROCAR 1.1mm DIA x 100mm
Photon, Photon Plus
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CERULOPLASMIN, MODEL 2055953
FDA 510(k)
FDA Class 2
·Immunology
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·February 16, 2022
POLYETHYLENE INLAY W/TANTALUM MARKER/MEDIUM-10MM-STERILE
FDA Adverse Event
Malfunction
·SYNTHES BRANDYWINE·Product code MJO·February 14, 2013
IMMULITE 2000
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.·Product code DGC·January 17, 2011
CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·July 28, 2014
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·November 23, 2017
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·December 14, 2016
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·March 15, 2018
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·April 11, 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