10 results
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32ms
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Sources: EU EUDAMED, US FDA
PROBE RETRACTOR, PART #S-2L8-6
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515198982·Crego Perio Elev, blunt, full cve, 7mm, 7 3/4"
The Orthodontic Store
FDA UDI
Young Innovations, Inc.·00843471183663·.022 L/R Std. Weld Size #14
GAMBRO CARTRIDGE BLOOD SETS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Arthrex Univers Revers Apex Humeral Stems
FDA 510(k)
FDA Class 2
·Orthopedic
CARTRIDGE
FDA Adverse Event
Injury
·GAMBRO RENAL PRODUCTS S.A. DE C.V.·Product code FJK·July 8, 2015
ONE TOUCH ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·May 13, 2010
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 6, 2014
GENESIS
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION·Product code LGW·October 1, 2012
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