13 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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DENVER ASCITES SHUNT AND PERCUTANEOUS ACCESS KIT WITH ASCITIES SHUNT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304081295·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304081301·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304081288·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304081257·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304081240·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304081271·
SYNTHETIC POWDER FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
ULTRAFREE MAX STERILE LATEX POWEDER-FREE SURGICAL GLOVES WITH PROTEIN LABELING CLAIM, 50 PER GRAM OR LESS OF TOTAL WATER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT
FDA Adverse Event
C.T.M. HOMECARE PRODUCT, INC·Product code INI·March 19, 2013
NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY
FDA Adverse Event
Death
·BIOSENSE WEBSTER, INC (IRWINDALE)·Product code OAD·March 9, 2011
ENDEAVOR RESOLUTE RX
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code NIQ·August 15, 2014
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