11 results
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21ms
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Sources: EU EUDAMED, US FDA
X9 Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
XELERIS 2 PROCESSING AND REVIEW WORKSTATION
FDA 510(k)
FDA Class 2
·Radiology
Aquilion ONE Vision with FIRST 1.0 (CCRS-001A)
FDA 510(k)
FDA Class 2
·Radiology
BD VACUTAINER® HEMOGARD¿ GLASS STERILE TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JKA·December 6, 2017
MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE S -4
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·September 12, 2022
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·November 14, 2014
LIFEPAK 20E DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code MKJ·August 31, 2011
UNK
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·July 29, 2013
CUP: MPACT ACETABULAR SHELL Ø52 TWO-HOLES
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·April 10, 2024
BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tubes, 4.5 mL, 13 x 75 mm, Mfd: Becton Dickinson and Company Product Usage: The BD Vacutainer Safety Coagulation tube is an evacuated blood collection Tube that provides means of collecting, transporting and processing blood in a closed tube. The buffered sodium citrate additive provides an anti-coagulated specimen that may be used for clinical laboratory coagulation assays and determinations.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·April 12, 2017
Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024