15 results · 19ms · Sources: EU EUDAMED, US FDA

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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