23 results · 27ms · Sources: EU EUDAMED, 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