14 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LEONE SPA
FDA UDI
LEONE SPA·08033707065821·EXTRAORAL ELASTICS 1/4" 8 oz
MARK 5 NUVO 8 OCSI, MARK 5 NUVO 8 STD
FDA 510(k)
FDA Class 2
·Anesthesiology
LEONE SPA
FDA UDI
LEONE SPA·08033707065814·EXTRAORAL ELASTICS 3/16" 8 oz
LEONE SPA
FDA UDI
LEONE SPA·08033707065838·EXTRAORAL ELASTICS 5/16" 8 oz
MICROLIFE DIGITAL INFRARED EAR THERMOMETER, IR1DAI, IR1DB1, IR1DD1
FDA 510(k)
FDA Class 2
·General Hospital
VENTLAB HYPERINFLATION BAG SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
PASS LP
FDA Adverse Event
Injury
·MEDICREA TECHNOLOGIES·Product code MNI·April 17, 2013
PASS LP
FDA Adverse Event
Injury
·MEDICREA·Product code MNI·April 17, 2013
ACCESS® 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code LTJ·May 6, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 16, 2014
REPLY
FDA Adverse Event
Malfunction
·SORIN CRM S.R.L.·Product code NVZ·April 15, 2011
PASS LP - LIAPASS
FDA Adverse Event
Injury
·MEDICREA TECHNOLOGIES·Product code MNI·March 29, 2013
PATIENT INFORMATION CENTER IX
FDA Adverse Event
Injury
·PHILIPS MEDICAL SYSTEMS·Product code MHX·August 21, 2023
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