24 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MASTER & FRANK SURGICAL DRAPES (STERILE)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·10304040051303·FILE - Channels PT Platinum - C3 31MM
BUSCH®, BNA®
FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120203931·Carbide, inverted cone, excavating and fissure bur
Midway Select
FDA UDI
MIDWAY DENTAL SUPPLY, LLC·10843717103889·Stainless Steel K Files (Hand), Size # 06, Leng...
OneTouch Ultrasoft
FDA UDI
LifeScan Europe GmbH·00353885393102·OneTouch Ultrasoft Lancets
NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
NOVA CORDLESS CURING LIGHT
FDA 510(k)
FDA Class 2
·Dental
BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·September 4, 2025
BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·February 23, 2026
APC PLUS, CLARITY, MINI UNI-TWIN, VICTORY SERIES
FDA Adverse Event
Injury
·3M UNITEK·Product code DYH·May 9, 2012
REBOUND HRD
FDA Adverse Event
Malfunction
·MINNESOTA MEDICAL DEVELOPMENT, INC.·Product code FTL·May 16, 2011
OT VERIO TEST STRIPS
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 26, 2013
TWINFIX FT TI RC 4.5
FDA Adverse Event
Malfunction
·SMITH & NEPHEW ENDOSCOPY·Product code MBI·March 16, 2011
EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM
FDA Adverse Event
Death
·EDWARDS LIFESCIENCES·Product code KRH·March 26, 2008
Stryker End Cap, Standard T2 Humerus ¿6 mm Catalog Number: 18300003S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 24, 2020
BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 22, 2024
BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code LON·January 9, 2024
BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·January 31, 2024
BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·December 26, 2023
BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code LON·February 21, 2024