4 results
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7ms
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Sources: EU EUDAMED, US FDA
WECK Hem-O-Lok AutoEndo5, 5mm Automatic Endoscopie Hem-o-lok Applier, REF 543965 Automatic Endoscopic Surgical Ligating Clip Appliers are delivery devices for Hem-o-lok ML non-absorbable polymer ligating clips
FDA Enforcement
Class II
·Ongoing·Teleflex Medical·November 27, 2019
WECK AutoEndo5, Automatic Hem-O-Lok Clip Applier, REF AE05ML Automatic Endoscopic Surgical Ligating Clip Appliers are delivery devices for Hem-o-lok ML non-absorbable polymer ligating clips
FDA Enforcement
Class II
·Ongoing·Teleflex Medical·November 27, 2019
8MM,LARGE HEM-O-LOK CLIP APPLIER,IS4000¿ REF 470230
FDA Enforcement
Class II
·Ongoing·Intuitive Surgical, Inc.·January 22, 2025
Hybrid Recon software on Hermes Medical Imaging Suite version 6.1 Hybrid Recon software versions affected are 4.0.0x and 5.0.0
FDA Enforcement
Class II
·Ongoing·Hermes Medical Solutions AB·December 18, 2024