8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COLPO-MASTER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MODIFICATION TO NANMA NON-ADJUSTABLE CONSTRICTION RING
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DYONICS VISION 635 IMAGE MANAGEMENT SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SILCONE COATED I/A 45 HANDHELD INSTRUMENT
FDA Adverse Event
Injury
·BAUSCH + LOMB·Product code HQC·May 7, 2019
SWAN-GANZ THERMODILUTION VENOUS INFUSION PORT (VIP) CATHETER WITH AMC THROMBOSHI
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES, PR·Product code DYG·April 23, 2013
RIATA ACTIVE FIXATION LEAD
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2008
GOBED+
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·April 21, 2011
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