8 results
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17ms
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Sources: EU EUDAMED, US FDA
HEEL/ELBOW PROTECTOR
FDA 510(k)
FDA Class 1
·General Hospital
Rubicon 14, 18 and 35 Support Catheters
FDA 510(k)
FDA Class 2
·Cardiovascular
IMMUNOCAP ALLERGEN F338, SCALLOP WITH MODEL(S): 14-4895-01
FDA 510(k)
FDA Class 2
·Immunology
COULTER® LH 780 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·April 25, 2014
FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code NBW·June 28, 2007
2.4MM TI CORTEX SCREW SELF-TAPPING 6MM
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code MQN·September 28, 2012
VANGUARD DA360 TIBIAL BEARING ARCOM 63/67X18
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·June 9, 2017
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