11 results
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27ms
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Sources: EU EUDAMED, US FDA
TELESONIC, GENERIC & SOUNDEX C-102
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
ACUMED
FDA UDI
Acumed LLC·10806378046247·3.0 mm Hexalobe Short Screw Caddy Lid
NAR Kit
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209114375·KIT, ROO K9 HANDLER M-FAK - BASIC - BLK
DADE BEHRING COAGULATION ANALYZER (BCT)
FDA 510(k)
FDA Class 2
·Hematology
FRACTURE/RECONSTRUCTION SYSTEM (TRAUMAONE)
FDA 510(k)
FDA Class 2
·Dental
ENDOPATH ETS
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code KOG·March 11, 1998
LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code LDD·May 8, 2014
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC·Product code GJS·October 17, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC., USA·Product code LFR·September 21, 2007
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
Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·July 22, 2015