8 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ZENITH HYLO AND VERTI-LIFT CHIROPRACTIC TABLES
FDA 510(k)
FDA Class 1
·Physical Medicine
AXSOS
FDA UDI
Stryker GmbH·07613154482634·Implant Tray - Prox. Tibia TS
MTG - MINITUB HEATED STAGE SYSTEMS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STK
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·June 30, 2014
BRAVO
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD.·Product code FFT·November 7, 2010
GREENLIGHT HPS BPH FIBER OPTIC
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS·Product code GEX·December 26, 2012
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