11 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FUJI LINING CEMENT LIGHT CURE
FDA 510(k)
FDA Class 2
·Dental
KAIYANG STEEL WHEELCHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
STERRAD 100S STERILIZER
FDA Adverse Event
Malfunction
·ADVANCED STERILIZATION PRODUCTS·Product code MLR·June 8, 2006
HARMONIC ACE 36CM W ERG HANDLE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·February 7, 2018
UNKNOWN_INSTRUMENTSTIRE_PRODUCT
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code GFF·June 30, 2014
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·November 12, 2010
AUTOPULSE RESUSCITATION SYSTEM MODEL 100
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION, INC.·Product code DRM·November 8, 2012
STERRAD 100NX STERILIZER 1-DR
FDA Adverse Event
Malfunction
·ADVANCED STERILIZATION PRODUCTS·Product code MLR·January 6, 2021
ROADRUNNER THE FIRM HYDROPHILIC WIRE GUIDE
FDA Adverse Event
Injury
·COOK INC·Product code DQX·January 26, 2018
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