6 results
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17ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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(1) Lumenis Pulse 120H 30 amp, REF GA 2009996, Laser System; (2) Lumenis Pulse 120H, Moses 2.0 (DOM), REF GA0006802, Laser System; and (3) Lumenis Pulse 120H, REF GA-0008700, Laser System.
FDA Enforcement
Class II
·Ongoing·LUMENIS, LTD.·March 12, 2025
Directional Laser Probe with Alcon / Lumenis connector (27 gauge / 0.4 mm)
FDA Enforcement
Class II
·Ongoing·D.O.R.C. Dutch Opthalmic Research Center Intl B.V.·March 27, 2024
Directional Laser Probe with Alcon / Lumenis connector (25 gauge / 0.5 mm)
FDA Enforcement
Class II
·Ongoing·D.O.R.C. Dutch Opthalmic Research Center Intl B.V.·March 27, 2024
Directional Laser Probe with Alcon / Lumenis connector (23 gauge / 0.6 mm)
FDA Enforcement
Class II
·Ongoing·D.O.R.C. Dutch Opthalmic Research Center Intl B.V.·March 27, 2024
OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including ablation, coagulation, incision, excision, and vaporization of soft tissue.
FDA Enforcement
Class II
·Ongoing·LUMENIS, LTD.·August 27, 2025
Power Injectable CT Port insertion kits - Product Usage: is an implantable access device designed to provide repeated access to the vascular system.
FDA Enforcement
Class II
·Ongoing·Medical Components, Inc dba MedComp·March 17, 2021