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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HOWMEDICA HNR SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Brigade
FDA UDI
Nuvasive, Inc.·00887517963741·Brigade Lateral Trial, 7x38x32mm 10°
POWDER-FREE NITRILE EXAM GLOVE, LAVENDER/PURPLE
FDA 510(k)
FDA Class 1
·General Hospital
IU22 ULTRASOUND SYSTEM AND TRANSDUCERS
FDA 510(k)
FDA Class 2
·Radiology
530G INSULIN PUMP
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·June 30, 2014
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·October 26, 2007
ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY
FDA Adverse Event
Injury
·COOK, INC.·Product code MIH·December 31, 2012
EV3 Pipeline Flex Embolization Device with Flex Shield Technology
FDA Enforcement
Class I
·Ongoing·Micro Therapeutics Inc,·September 15, 2021
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