23 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SYNTHES USS (10.0MM SIDE OPENING SCREWS)
FDA 510(k)
FDA Class 2
·Orthopedic
ZEVO™ Anterior Cervical Plate System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00763000663094·PLATE 3003061 ZEVO 61MM 3 LVL
ZEVO™ Anterior Cervical Plate System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169329522·PLATE 3003061 ZEVO 61MM 3 LVL
Premier Carvers
FDA UDI
PREMIER DENTAL PRODUCTS COMPANY·00348783009248·Carver DE_Shooshan A
Prime-Core DC Automix Core Build Up Material
FDA UDI
PRIME DENTAL·00817441023563·Prime-Core DC Automix Core Build Up Material - ...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523184927·Kerrison Rongeur, Angled Right - 3mm
MINXRAY HF70D HIGH FREQUENCY PORTABLE DENTAL X-RAY UNIT
FDA 510(k)
FDA Class 2
·Dental
K-ASSAY AT-III
FDA 510(k)
FDA Class 2
·Hematology
MEDTRONIC EXTENDED
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·July 27, 2024
MEDTRONIC EXTENDED INFUSION SET
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·February 5, 2025
V500, SAVINA AND VENTILATORS OF EVITA FAMILY
FDA Adverse Event
Other
·DRAGER MEDICAL GMBH·Product code CBK·February 18, 2011
PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES
FDA Adverse Event
MEDEL S.P.A.·Product code BTI·March 13, 2013
RESERVOIR 1.8 ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code FRN·February 8, 2011
BD FIRST PICC PERIPHERALLY INSERTED CENTRAL CATHETER
FDA Adverse Event
Other
·BECTON DICKINSON INFUSION THERAPY SYSTEMS·Product code LJS·February 22, 2008
BD BACTEC¿ MGIT¿ 960 SIRE KIT
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code MJA·May 6, 2022
BD BACTEC¿ MGIT¿ 960 SIRE KIT
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code MJA·June 30, 2025
BD BBL Sensi Disc Moxifloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231758¿
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·February 14, 2024
BD BACTEC¿ MGIT¿ 960 SIRE KIT
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code MJA·September 19, 2023
BD BACTEC¿ MGIT¿ 960 SIRE KIT
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code MJA·March 26, 2022
iChemVELOCITY Urine Chemistry System, Catalog No. 800-3530, 800-7167, 800-7719, 800-7720, 800-3564, 800-7100, 800-7103, 800-7106, 800-7162, 800-7163, 800-7166, 800-3061. The iChem Velocity automated urine chemistry system is used to test for the following analytes in urine: ketones, blood, protein, glucose, bilirubin, urobilinogen, nitrite, leukocyte esterase, specific gravity, pH, ascorbic acid, color, and clarity. The iChem Velocity automated urine chemistry analyzer is intended to be used for in vitro measurement of various analytes in urine; it is intended for use only with the iChem Velocity urine chemistry strips
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code KQO·January 30, 2017