12 results
·
21ms
·
Sources: EU EUDAMED, US FDA
INPERSOL-CAPD ADMINISTRATION SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
N/A
FDA UDI
GEORGE TIEMANN & CO.·B5828018810·RETRACTOR, ALL TYPES
ACUMED
FDA UDI
Acumed LLC·10806378052071·13mm Washer Sleeve
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209136841·
IMPROVED ENLIGHT LV
FDA 510(k)
FDA Class 2
·Dental
GISH TUBING AND CONNECTORS WITH HA COATING
FDA 510(k)
FDA Class 2
·Cardiovascular
7700
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·February 11, 2014
ASR ACETABULAR CUPS 60
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·October 23, 2012
ARTICULEZE M HEAD 36MM +1.5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·May 28, 2015
Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
FDA Enforcement
Class I
·Ongoing·Zyno Medical LLC·June 18, 2025
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 REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024