8 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COMFIT, PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
VERILAST WEAR CLAIMS FOR THE LEGION PRIMARY KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
3D-DOCTOR
FDA 510(k)
FDA Class 2
·Radiology
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·June 30, 2014
MATERNIT21
FDA Adverse Event
Injury
·SEQUENOM·Product code OQS·January 2, 2013
CXD II
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - LARGO·Product code KDJ·November 20, 2010
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