18 results
·
19ms
·
Sources: EU EUDAMED, US FDA
DIGITAL X-RAY IMAGING SYSTEM, MODEL PAX-UNI3D
FDA 510(k)
FDA Class 2
·Radiology
Amara Gel
FDA UDI
Respironics, Inc.·00606959013926·Amara Gel FitPack
N/A
FDA UDI
BIOMET MICROFIXATION, INC·00841036029739·
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776364267·Oral Lower Anterior Molar
UNIVERSAL DENTAL COPING (UDC)
FDA 510(k)
FDA Class 2
·Dental
URINE COCAINE METABOLITE (COC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A
FDA 510(k)
FDA Class 2
·Clinical Toxicology
AXXENT FLEXISHIELD MINI (K090417)
FDA Adverse Event
Injury
·XOFT, INC.·Product code IXI·January 7, 2011
BD BBL Sensi Disc Cefotaxime - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231606 and 231607¿; 5 ug, Catalog No. 291308¿
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·February 14, 2024
HEARTSINE SAMARITAN 300P AND PAD PAK
FDA Adverse Event
Malfunction
·HEARTSINE TECHNOLOGIES LTD·Product code MKJ·September 21, 2015
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·May 2, 2013
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 15, 2014
BD TRUCOUNT TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·July 13, 2021
BD TRUCOUNT TUBES
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code GKZ·July 15, 2021
BD MULTITEST¿
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·February 9, 2024
BD MULTITEST¿
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code GKZ·March 15, 2024
BD MULTITEST¿
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND COMPANY BD BIOSCIENCES·Product code GKZ·March 15, 2024
BD MULTITEST¿
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code GKZ·March 15, 2024
BD TRUCOUNT¿ TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·May 2, 2025