8 results
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20ms
·
Sources: EU EUDAMED, US FDA
FIBER OPTIC ADAPTER #60-895
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
PROTRON TECHNOLOGIES, LLC STETHOTRON
FDA 510(k)
FDA Class 2
·Cardiovascular
BIOPSY HANDY, MRI BIOPSY HANDY
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ADAPTER SLEEVES 12/14 +5
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·October 24, 2012
SYMBIQ DUAL CHANNEL
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·February 21, 2014
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·October 1, 2007
Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
FDA Enforcement
Class I
·Ongoing·Zyno Medical LLC·June 18, 2025
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