22 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CLINIQA LIQUID QC COMPLETE CARDIAC MARKER CONTROL, LEVELS 1,2, AND 3; CARDIAC MARKER CONTROL-LOW, AND LINICAL CARDIAC
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DIASCREEN 50 URINE CHEMISTRY ANALYZER, MODEL # 1242-00; DIASCREEN REAGENT STRIP FOR URINALYSIS, CAT. # D11000
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BEHRING COAGULATION SYSTEM (BCS)
FDA 510(k)
FDA Class 2
·Hematology
BILOX PROSTHESIS HEAD 12/14 28MM L
FDA Adverse Event
Malfunction
·AESCULAP AG AND CO. KG·Product code LWJ·May 23, 2014
EXCIA L PLASMAPORE UCAP 8/10 SIZE 11MM
FDA Adverse Event
Malfunction
·AESCULAP AG AND CO. KG·Product code LWJ·March 6, 2014
ISODUR PROSTHESIS HEAD 12/14 32MM L
FDA Adverse Event
Malfunction
·AESCULAP AG&CO KG·Product code LPH·August 7, 2014
QUINTEX SEMICONSTRAINED SCREW 4.0X16MM
FDA Adverse Event
Malfunction
·AESCULAP AG AND CO. KG·Product code LWJ·March 6, 2014
BIOLOX PROSTHESIS HEAD 12/14 28MM S
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code LWJ·April 27, 2012
EXCIA PLASMAPORE-UCAP 8/10 SIZE 11MM
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code MEH·June 21, 2013
EXCIA CEMENTED 8/10 SIZE 12MM
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code JDI·November 5, 2012
BIOLOX PROSTHESIS HEAD 12/14 28MM S
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code LWJ·April 14, 2014
BIOLOX PROSTHESIS HEAD 12/14 28MM M
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code LWJ·April 27, 2012
BIOLOX PROSTHESIS HEAD 12/14 32MM L
FDA Adverse Event
Malfunction
·AESCULAP AG AND CO. KG·Product code LWJ·March 6, 2014
BIOLOX PROSTHESIS HEAD 8/10 32MM M
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code LZO·June 21, 2013
BIOLOX PROSTHESIS HEAD 12/14 28MM S
FDA Adverse Event
Malfunction
·AESCULAP AG AND CO. KG·Product code LWJ·March 6, 2014
STELLARIS 25G VITRECTOMY CUTTER
FDA Adverse Event
Malfunction
·BAUSCH & LOMB, INC.·Product code HQC·April 24, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·May 9, 2011
LIGHTSHEER
FDA Adverse Event
Other
·LUMENIS, LTD.·Product code GEX·July 18, 2008
ISODUR PROSTHESIS HEAD 12/14 28MM M
FDA Adverse Event
Malfunction
·AESCULAP AG AND CO. KG·Product code LPH·January 16, 2015
EVOLUT FX DCS
FDA Adverse Event
Malfunction
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·July 18, 2025