10 results
·
27ms
·
Sources: EU EUDAMED, US FDA
Natrelle 133S Tissue Expanders
FDA 510(k)
FDA Unclassified
·Unknown
Orion Headless Screw
FDA UDI
Tyber Medical, LLC·M695HTR042541260·ORION Ø2.5mm Headless Cannulated Screw, Short T...
ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SKOUT system
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FINELINE II
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code DTB·November 11, 2008
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·September 19, 2011
X FLOW DUFO 3WAY SIL 50 ML CH18
FDA Adverse Event
Malfunction
·COLOPLAST A/S·Product code EZL·July 30, 2013
Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the DIMMs (Dual In-line Memory Modules) used with affected systems. Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026; Allura Xper FD10/10 722005 722011 722027; Allura Xper FD10C 722001; Allura Xper FD20 722006 722012 722028; Allura Xper FD20 Biplane 722008 722013; Allura Xper FD20 Biplane OR Table 722025; Allura Xper FD20 OR Table 722023 722035; Allura Xper FD20/10 722029; Allura Xper FD20/15 722058; Allura Xper FD20/20 722038; Allura Xper FD20/20 OR Table 722039; (Allura Centron - 722400 is impacted by this recall, but Allura Centron systems are not distributed in the United States.)
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025