9 results
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18ms
·
Sources: EU EUDAMED, US FDA
ABL SYSTEM 625, 615, 605
FDA 510(k)
FDA Class 2
·Clinical Chemistry
I/A-PHACO SYSTEM (IRR./ASPIR./AND PHACO./SYSTEM)
FDA 510(k)
FDA Class 2
·Ophthalmic
ACUTE HEMODIALYSIS TRAY, CAT.#09-9540-7
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LOGIC CR FEMORAL POR, RIGHT, SZ 3
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·November 20, 2024
CONSULTA CRT-D
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·February 11, 2013
POLYURETHANE URETERAL CATHETER
FDA Adverse Event
Injury
·C.R. BARD, INC.·Product code EYB·December 17, 2010
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·July 17, 2014
LOGIC CR TIB INSERT STD, SZ 3, 11MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·March 1, 2023
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