17 results
·
25ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MODEL D DISC FORCE
FDA 510(k)
FDA Class 2
·Physical Medicine
SIGN IM NAIL
FDA 510(k)
FDA Class 2
·Orthopedic
DERMAGRIP POWDER FREE BLUE POLYMER COATED LATEX EXAMINATION GLOVE, NON-STERILE CONTAINS 50 MICROGRAM OR LESS OF TOTAL WA
FDA 510(k)
FDA Class 1
·General Hospital
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 22, 2020
BIVONA
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code JOH·June 26, 2020
PULSE GEN MODEL 102
FDA Adverse Event
Injury
·CYBERONICS INC·Product code LYJ·April 23, 2013
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·March 25, 2011
RIATA ST PASSIVE FIXATION LEAD
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2008
TOSOH HLC-723G8 ANALYZER
FDA Adverse Event
Malfunction
·TOSOH CORPORATION·Product code LCP·December 20, 2017
TOSOH HLC-723G8 ANALYZER
FDA Adverse Event
Malfunction
·TOSOH CORPORATION·Product code LCP·December 15, 2017
TOSOH HLC-723G8 ANALYZER
FDA Adverse Event
Malfunction
·TOSOH CORPORATION·Product code LCP·December 20, 2017
TOSOH HLC-723G8 ANALYZER
FDA Adverse Event
Malfunction
·TOSOH CORPORATION·Product code LCP·December 11, 2017
TOSOH HLC-723G8 ANALYZER G8
FDA Adverse Event
Injury
·TOSOH CORPORATION·Product code LCP·January 5, 2016
TOSOH HLC-723G8 ANALYZER G8
FDA Adverse Event
Injury
·TOSOH CORPORATION·Product code LCP·January 3, 2017
TOSOH HLC-723G8 ANALYZER G8
FDA Adverse Event
Malfunction
·TOSOH CORPORATION·Product code LCP·April 16, 2018
Silhouette Paradigm 13mm, 18"; Silhouette 43"; Silhouette 23"; Silhouette Paradigm 43"; Silhouette Paradigm 23"; Silhouette Paradigm 13mm, 23"; Silhouette Paradigm 13mm, 43"; Silhouette Paradigm 13mm, 32"; Silhouette Paradigm 32" The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin
FDA Enforcement
Class II
·Terminated·Unomedical As·November 9, 2016
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012