9 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CALCIUM ARSENAZO III REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TITAN PLUG SCREW 8MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA GMBH·Product code HSB·February 21, 2002
ETHICON ENDO SURGERY SLOTTED ANOSCOPE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LYMPHA VISION-EXPERT
FDA 510(k)
FDA Class 2
·Neurology
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 30, 2014
UNIVERSAL ACETABULAR SHELL WITH PLUG 44MM/SOLID W/APICAL DOME HOLE
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LPH·November 20, 2010
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·November 28, 2012
Colonoscope, Model Number PCF-H180AL.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·March 6, 2024
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