12 results
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25ms
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Sources: EU EUDAMED, US FDA
CUSTOM DRESSING TRAY-WET TO DRY/MASS.
FDA 510(k)
FDA Class 1
·General Hospital
ACUMED
FDA UDI
Acumed LLC·10806378099328·Small Fragment Base Set Screw Caddy Base
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450047682·
CHAPERON GUIDING CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
COOK IVF FOLLICLE FLUSHING BUFFER, COOK IVF OOCYTE WASH BUFFER, COOK IVF FERTILIZATION MEDIUM, COOK IVF CLEAVAGE MEDIUM,
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
UNKNOWN DEPUY SZ 4 MBT REV TIB TRAY
FDA Adverse Event
Injury
·Product code JWH·October 24, 2012
POWERGLIDE MIDLINE CATHETER FULL KIT (20G) (10CM)
FDA Adverse Event
Malfunction
·C.R. BARD, INC. (BASD)·Product code FOZ·February 21, 2014
INV SNAP VCATH, BIOGLIDE, 5CM
FDA Adverse Event
Injury
·MEDTRONIC NEUROSURGERY·Product code JXG·August 4, 2010
Baxter EXACTAMIX Inlet, Non-Vented, High-Volume Inlet, REF H938173 Product Usage: Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used in the pharmacy to compound multiple source ingredients into one final solution.
FDA Enforcement
Class II
·Terminated·Baxter Healthcare Corporation·May 30, 2018
Custom Fluid Management Set, Sterile, EO, Rx Only Used to transfer contrast media and saline from a container to a patients vascular system.
FDA Enforcement
Class II
·Terminated·Merit Medical Systems, Inc.·November 30, 2016
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022
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