9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODIFIED MOLTENO(TM) IMPLANTS
FDA 510(k)
FDA Class 2
·Ophthalmic
VANTAGE TITAN 3T
FDA 510(k)
FDA Class 2
·Radiology
INTUITIVE SURGICAL DA VINCI ENDOSCOPIC CONTROL SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DA VINCI ROBOTICS SYSTEM
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC.·Product code NAY·October 21, 2003
FLOGARD
FDA Adverse Event
Malfunction
·SHARP CORPORATION OSAKA JAPAN·Product code FRN·June 30, 2014
EYE SURGERY STRETCHER
FDA Adverse Event
Malfunction
·STRYKER CORP., MEDICAL DIV.·Product code FPO·November 12, 2010
PLATE REDUCTION WIRE 01.25 W/LARGE STOP
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HRS·January 8, 2013
UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·August 13, 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