26 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Dentis I-FIX Abutment
FDA 510(k)
FDA Class 2
·Dental
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114155·KRATZ POLISHER 23GA END (PK/10)
Vilex Guidewire
FDA UDI
VILEX IN TENNESSEE, INC.·00841731120663·Guidewire 2.0x230mm Sgl Trocar
Vilex Guidewire
FDA UDI
VILEX IN TENNESSEE, INC.·00841731120656·Guidewire 2.0x230mm Drill Tip
LONG WELL LW-6DXX SERIES BODY FAT ANALYZER
FDA 510(k)
FDA Class 2
·Cardiovascular
Infrascanner
FDA 510(k)
FDA Class 2
·Ophthalmic
SILK SUTURE
FDA Adverse Event
Malfunction
·CP MEDICAL·Product code GAP·May 10, 2024
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 10, 2024
ACRYSOF RESTOR
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD/HUNTINGTON·Product code MFK·November 13, 2008
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FPA·September 1, 2011
FREEDOME SELF CATH PLUS MALE CH08
FDA Adverse Event
Injury
·COLOPLAST A/S·Product code KOD·July 16, 2013
BD¿ BLUNT FILL NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·July 20, 2023
BD® BLUNT FILL NEEDLE 18 G X 1 1/2 IN
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·August 4, 2023
Monoject 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack
FDA Enforcement
Class I
·Ongoing·Cardinal Health 200, LLC·November 1, 2023
Monoject" 6 mL Syringe Luer-Lock Tip Soft Pack
FDA Enforcement
Class I
·Ongoing·Cardinal Health 200, LLC·November 1, 2023
Monoject 20 mL Syringe Luer-Lock Tip Soft Pack
FDA Enforcement
Class I
·Ongoing·Cardinal Health 200, LLC·November 1, 2023
EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.1. Phakic Toric Intraocular lens.
FDA Enforcement
Class II
·Ongoing·Staar Surgical Company·December 13, 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, 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, REF 1180100777
FDA Enforcement
Class I
·Ongoing·Cardinal Health 200, LLC·February 14, 2024
Cardinal Health Monoject, 6 mL Syringe Luer-Lock Tip Soft Pack, REF 1180600777
FDA Enforcement
Class I
·Ongoing·Cardinal Health 200, LLC·February 14, 2024