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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GE DATEX-OHMEDA ENGSTROM CARESTATION
FDA 510(k)
FDA Class 2
·Anesthesiology
LEONE SPA
FDA UDI
LEONE SPA·08033707000075·BI-FAN TYPE SCREWS S/STEEL 14mm
POWDER-FREE MULTI-PLY LATEX EXAMINATION GLOVES, POLYMER COATED ON OUTSIDE AND NITRILE COATED ON INSIDE, BLUE COLOR WITH
FDA 510(k)
FDA Class 1
·General Hospital
AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PREMIUM PLUS CEEA
FDA Adverse Event
Malfunction
·US SURGICAL PUERTO RICO·Product code GDW·April 19, 2018
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 11, 2013
INFRAVISION URETERAL KIT
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY SAN JOSE·Product code EZN·May 22, 2008
DA+ T SERIES DR
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code DXY·April 12, 2011
OT ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·December 10, 2010
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWQ·January 10, 2019
FT4, FREE THYROXINE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code CEC·September 30, 2016
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