12 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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MICROMATE
FDA 510(k)
FDA Class 2
·Radiology
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114209·SILICONE TIP CANNULA 27GA (PK/10)
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668113875·VISCO INJECTION CANNULA 30GA ANG 10MM
Needle aspiration and injection
FDA UDI
KATENA PRODUCTS, INC.·00841668113615·PERIBULBAR NEEDLE 23GA 32MM
PEN NDL 32G 4MM HP 100 BOX 1200 US
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·April 19, 2021
ANGEL OF WATER COLON HYDROTHERAPY SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SONOLINE ANTARES ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
PEN NDL 32G 4MM HP 100 BOX 1200 US
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·March 7, 2021
ONE TOUCH ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·October 9, 2008
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011
COTTON TIP APPLICATOR
FDA Adverse Event
Injury
·MEDLINE INDUSTRIES, INC.·Product code KXG·June 25, 2013
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