15 results
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19ms
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Sources: EU EUDAMED, US FDA
CHOLESTECH LIPID MONITORING SYS.
FDA 510(k)
FDA Class 1
·Clinical Chemistry
JUGGERKNOT FLEXIBLE DRILL BIT
FDA UDI
Biomet Orthopedics, LLC·00880304564022·
JuggerKnot®
FDA UDI
Biomet Orthopedics, LLC·00887868511929·
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471122932·K-WIRE - DOUBLE TROCAR 1.25mm DIA x 150mm
Malibu
FDA UDI
Seaspine Orthopedics Corporation·10889981080778·Counter Torque, Extended
TOP DRAPE STERILE, TOP DRAPE-NON STERILE, BOTTOM DRAPE- STERILE, BOTTOM DRAPE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AVITA AGIL IT 101 INSTANT DIGITAL THERMOMETER
FDA 510(k)
FDA Class 2
·General Hospital
DIMENSION® XPAND PLUS WITH HM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC- BROOKFIELD·Product code MSK·January 11, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·December 2, 2010
VITALITY 2
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 3, 2014
SYRINGE 5ML LS 21X1-1/2 AN EMERALD
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·December 1, 2020
LIGACLIP
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·September 26, 2017
Reprocessed Microline Scissor Tips intended to be used with a reusable hand piece and designed for minimally invasive and open surgical procedures to facilitate cutting, preparation, mobilization, and coagulation of tissue. Model #'s MIC3112, MIC3122, MIC3132, MIC3142, MIC3152, MIC3162.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·June 8, 2016
PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017
PM 1260 ASSURITY + These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017