Medical Device Manufacturer · US , Dublin , CA

Carl Zeiss Meditec, AG

45 submissions · 44 cleared · Since 2004
45
Total
44
Cleared
0
Denied

Carl Zeiss Meditec, AG — FDA 510(k) Submissions

Carl Zeiss Meditec, AG has submitted 45 FDA 510(k) premarket notifications since 2004, of which 44 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, Image Management, Ophthalmic, Biomicroscope, Slit-lamp, Ac-powered, Tomography, Optical Coherence, Powered Laser Surgical Instrument, Laser, Ophthalmic . Use the specialty filter in the sidebar to narrow results.

45 devices
1–25 of 45
INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator)
K241174 · JAD System, Therapeutic, X-ray · Radiology
Jan 2025 259d
VISULAS combi
K233911 · HQF Laser, Ophthalmic · Ophthalmic
Sep 2024 269d
BLUE 400; BLUE 400 S
K240215 · QFX Diagnostic Neurosurgical... · Neurology
Jun 2024 154d
RESCAN 700
K233421 · OBO Tomography, Optical... · Ophthalmic
Mar 2024 150d
CALLISTO eye
K232944 · NFJ System, Image Management,... · Ophthalmic
Dec 2023 92d
QEVO System
K232159 · GWG Endoscope, Neurological · Neurology
Sep 2023 63d
CALLISTO eye
K231676 · NFJ System, Image Management,... · Ophthalmic
Aug 2023 80d
QUATERA 700
K230858 · HQC Unit, Phacofragmentation · Ophthalmic
Jul 2023 124d
FORUM
K213527 · NFJ System, Image Management,... · Ophthalmic
Aug 2022 284d
BLUE 400
K211346 · QFX Diagnostic Neurosurgical... · Neurology
Jul 2022 445d
QUATERA 700
K212241 · HQC Unit, Phacofragmentation · Ophthalmic
Apr 2022 274d
CONVIVO In Vivo Pathology Suite
K211156 · LLZ System, Image Processing,... · Neurology
Dec 2021 254d
Visalis V500, Visalis S500
K193376 · HQC Unit, Phacofragmentation · Ophthalmic
Jun 2020 193d
VISULAS green
K181682 · HQF Laser, Ophthalmic · Ophthalmic
Mar 2019 253d
RESCAN 700, CALLISTO eye
K180229 · OBO Tomography, Optical... · Ophthalmic
Jan 2019 350d
CONVIVO
K181116 · GWG Endoscope, Neurological · General & Plastic Surgery
Oct 2018 181d
IOLMaster 700
K173771 · HJO Biomicroscope, Slit-lamp,... · Ophthalmic
Aug 2018 256d
CALLISTO eye
K180858 · NFJ System, Image Management,... · Ophthalmic
Jun 2018 86d
AT 030
K180839 · HKY Tonometer, Manual · Ophthalmic
Jun 2018 69d
QEVO System with KINEVO 900
K170667 · GWG Endoscope, Neurological · Neurology
Aug 2017 165d
YELLOW 560 Fluorescence Module
K162991 · IZI System, X-ray, Angiographic · Radiology
Jul 2017 270d
Retina Workplace
K170638 · NFJ System, Image Management,... · Ophthalmic
Jun 2017 111d
SL 220
K162684 · HJO Biomicroscope, Slit-lamp,... · Ophthalmic
May 2017 247d
IOLMaster 700
K170171 · HJO Biomicroscope, Slit-lamp,... · Ophthalmic
Apr 2017 77d
VISULUX
K161607 · HJO Biomicroscope, Slit-lamp,... · Ophthalmic
Feb 2017 258d
Filters