9 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING AND SILVER IMPREGNATED SLEEVE (PALINDROME SAPPHIRE)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
KENTRON HEALTH CARE, INC.
FDA registration
KENTRON HEALTH CARE, INC.·28 products·🇺🇸 United States
EZ-TRAVELER 2500 SERIES MANUAL WHEELCHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
FREEFORM BLUE POWDERFREE NITRILE EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
LIGASURE
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO HEALTHCARE·Product code GEI·March 21, 2013
FLANGE FIXTURE AND ABUTMENT
FDA Adverse Event
Injury
·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·April 19, 2011
DEXTRUS 4136
FDA Adverse Event
Injury
·BIOTRONIK GMBH AND CO.·Product code DTB·June 10, 2008
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
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015