13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MyCRO Band
FDA 510(k)
FDA Class 2
·Neurology
Dornier MedTech
FDA UDI
DORNIER MEDTECH AMERICA, INC.·04049958003875·1000 micron Holmium Laser Fiber Cable, Reusable...
ABSORBENT PAPER POINTS
FDA UDI
DiaDent Group International·08806383511636·"An absorbent paper points is an endodontic pap...
KAWASUMI LABORATORIES IV ADMINISTRATION SET WITH FILTER
FDA 510(k)
FDA Class 2
·General Hospital
CEROS TCP GRANULES
FDA 510(k)
FDA Class 2
·Dental
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·June 30, 2014
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 26, 2013
VASOVIEW HEMOPRO 2 WITH VASOSHIELD
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code GEI·August 3, 2011
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·September 17, 2014
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·February 28, 2014
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·November 23, 2017
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·October 17, 2017
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