5 results
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6ms
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Sources: EU EUDAMED, US FDA
Battery Mobile X-ray Unit EASY MOVING Model with telescopic column 3.1, model numbers: a. SM-20HF-Batt; b. SM-32HF-Batt; c. SM-40HF-Batt; d. SM-50HF-Batt; e. SM-40-HF-B-D-VIR; f. SM-20HF-B-D-KM (AeroDR X30); g. SM-32-HF-B-D-KM (AeroDR X30); h. SM-40HF-B-D-KM (AeroDR X30); i. SM-50HF-B-D-KM (AeroDR X30); j. MobileDiagnost wDR.
FDA Enforcement
Class II
·Ongoing·SEDECAL SA·May 8, 2024
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
Sedecal Mobile Digital Diagnostic X-Ray Systems; SM-40HF-B-D-KM (AeroDR X30)
FDA Enforcement
Class II
·Ongoing·SEDECAL SA·October 29, 2025