15 results
·
38ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
BWF-5 MEDICAL LASER SERIES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SINGLE DOSE DISPENSING PIN, MODEL 2201
FDA 510(k)
FDA Class 2
·General Hospital
MODIFICATION TO SPORICIDIN STERILIZING AND DISINFECTING SOLUTION
FDA 510(k)
FDA Class 2
·General Hospital
VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code JLW·February 2, 2016
VITROS ECI IMMUNODIAGNOSTIC SYSTEM
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code KHO·February 2, 2016
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 3, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 16, 2014
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 3, 2011
CAIMAN DISP.INSTR.NON ARTICUL.D:5/360MM
FDA Adverse Event
Malfunction
·AESCULAP, INC.·Product code GEI·April 15, 2015
UNKNOWN VLOC PRODUCT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 2015
UNKNOWN VLOC PRODUCT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 2015
UNKNOWN VLOC PRODUCT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 2015
VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code JLW·February 2, 2016
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
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018