24 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Blue Nitrile Examination Gloves Powder Free
FDA 510(k)
FDA Class 1
·General Hospital
PYRENEES® Cervical Plate System
FDA UDI
VB Spine LLC·10888857241954·Fixed Drill Guide Translational
Vasomedical-Biox™ 2306 Combined 12 CH ECG Holter & ABP Monitor with Bluetooth
FDA UDI
VASOMEDICAL, INC.·00817980020122·12 CH ECG Holter/ABP COMB Recorder w/Bluetooth
VERTE-STACK SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
BIOROOT RCS
FDA 510(k)
FDA Class 2
·Dental
BOOMERANG PEEK FUSION DEVICE
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code MQP·January 14, 2011
GRANUFLO
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·October 22, 2014
OCTRODE LEAD, 90CM LENGTH
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·August 12, 2011
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·July 16, 2013
BD NEEDLE 18X1-1/2 RB TW
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·October 26, 2023
Monoject" 60 mL Syringe Luer-Lock Tip Soft Pack
FDA Enforcement
Class I
·Ongoing·Cardinal Health 200, LLC·November 1, 2023
Monoject" 35 mL Syringe Luer-Lock Tip Soft Pack
FDA Enforcement
Class I
·Ongoing·Cardinal Health 200, LLC·November 1, 2023
Monoject 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack
FDA Enforcement
Class I
·Ongoing·Cardinal Health 200, LLC·November 1, 2023
Monoject(TM) 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, Model Number/Product Code: 1180100777
FDA Enforcement
Class II
·Ongoing·Cardinal Health 200, LLC·October 25, 2023
Cardinal Health Monoject, 12mL Enteral Syringe (purple) For Use with ENFit Connection System, REF 412SE
FDA Enforcement
Class I
·Ongoing·Cardinal Health 200, LLC·February 14, 2024
Cardinal Health Monoject, 35mL Enteral Syringe (purple) - For Use with ENFit Connection System, REF 435SE
FDA Enforcement
Class I
·Ongoing·Cardinal Health 200, LLC·February 14, 2024
Cardinal Health Monoject, 60 mL Syringe Luer-Lock Tip Soft Pack, REF 1186000777T
FDA Enforcement
Class I
·Ongoing·Cardinal Health 200, LLC·February 14, 2024
Cardinal Health Monoject, 3 mL Purple Enteral Syringe with Enfit Connection Sterile, REF 403SE
FDA Enforcement
Class I
·Ongoing·Cardinal Health 200, LLC·February 14, 2024
Cardinal Health Monoject, 35 mL Syringe Luer-Lock Tip Soft Pack, REF 1183500777
FDA Enforcement
Class I
·Ongoing·Cardinal Health 200, LLC·February 14, 2024
Cardinal Health Monoject, 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, REF 1180100777
FDA Enforcement
Class I
·Ongoing·Cardinal Health 200, LLC·February 14, 2024