Company · US
Carl Zeiss Meditec, AG
FDA 510(k) clearances and medical device recalls filed under this name, 1993 to 2026. Name variants (Inc, Corp, punctuation) are merged.
77510(k) clearances (2 in 12 months)
28recalls (1 in 12 months)
20recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| OBO | Tomography, Optical Coherence | 17 |
| HJO | Biomicroscope, Slit-Lamp, Ac-Powered | 15 |
| NFJ | System, Image Management, Ophthalmic | 14 |
| JAD | System, Therapeutic, X-Ray | 10 |
| HLI | Ophthalmoscope, Ac-Powered | 8 |
| HQF | Laser, Ophthalmic | 7 |
| EPT | Microscope, Surgical | 4 |
| GEX | Powered Laser Surgical Instrument | 4 |
| GWG | Endoscope, Neurological | 3 |
| HQC | Unit, Phacofragmentation | 3 |
| QER | Camera, Ophthalmic, Slit-Scanning | 3 |
| HKI | Camera, Ophthalmic, Ac-Powered | 2 |
| IZI | System, X-Ray, Angiographic | 2 |
| MYC | Ophthalmoscope, Laser, Scanning | 2 |
| QFX | Diagnostic Neurosurgical Microscope Filter | 2 |
| HKO | Refractometer, Ophthalmic | 1 |
| HKY | Tonometer, Manual | 1 |
| HLM | Instrument, Measuring, Lens, Ac-Powered | 1 |
| HNO | Keratome, Ac-Powered | 1 |
| HNQ | Hook, Ophthalmic | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 15, 2026 | K261361 | TORUS Ultrasonic Aspirator System; and accessories (TORUS Single-Use Tubing Sets, TORUS Single-Use Torque Wrenches, TORU Carl Zeiss Meditec, AG, DE | LFL |
| Jul 17, 2026 | K260694 | ZEISS CLINIC 360 Carl Zeiss Meditec, AG, DE | NFJ |
| Apr 17, 2025 | K243878 | CLARUS (700) Carl Zeiss Meditec, Inc. | QER |
| Jan 10, 2025 | K241174 | INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Carl Zeiss Meditec, AG, DE | JAD |
| Sep 6, 2024 | K233911 | VISULAS combi Carl Zeiss Meditec, AG, DE | HQF |
| Jun 28, 2024 | K240215 | BLUE 400; BLUE 400 S Carl Zeiss Meditec, AG, DE | QFX |
| May 17, 2024 | K233933 | CIRRUS HD-OCT Model 6000 Carl Zeiss Meditec, Inc. | OBO |
| Mar 8, 2024 | K233421 | RESCAN 700 Carl Zeiss Meditec, AG, DE | OBO |
| Dec 21, 2023 | K232944 | CALLISTO eye Carl Zeiss Meditec, AG | NFJ |
| Oct 24, 2023 | K232051 | VISULAS green Carl Zeiss Meditec | HQF |
| Sep 22, 2023 | K230350 | VISULAS yag Carl Zeiss Meditec, Inc. | HQF |
| Sep 21, 2023 | K232159 | QEVO System Carl Zeiss Meditec, AG, DE | GWG |
| Aug 28, 2023 | K231676 | CALLISTO eye Carl Zeiss Meditec, AG, DE | NFJ |
| Jul 31, 2023 | K230858 | QUATERA 700 Carl Zeiss Meditec, AG, DE | HQC |
| Jun 20, 2023 | K231075 | Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option) Carl Zeiss Meditec, Inc. | IZI |
| Apr 13, 2023 | K222200 | CIRRUS HD-OCT Carl Zeiss Meditec, Inc. | OBO |
| Aug 15, 2022 | K213527 | FORUM Carl Zeiss Meditec, AG, DE | NFJ |
| Jul 22, 2022 | K211346 | BLUE 400 Carl Zeiss Meditec, AG, DE | QFX |
| Apr 19, 2022 | K212241 | QUATERA 700 Carl Zeiss Meditec, AG, DE | HQC |
| Dec 29, 2021 | K211156 | CONVIVO In Vivo Pathology Suite Carl Zeiss Meditec, AG, DE | LLZ |
| Jun 15, 2020 | K193376 | Visalis V500, Visalis S500 Carl Zeiss Meditec, AG, DE | HQC |
| Jun 25, 2019 | K191194 | CLARUS Carl Zeiss Meditec, Inc. | QER |
| Mar 6, 2019 | K181682 | VISULAS green Carl Zeiss Meditec, AG, DE | HQF |
| Feb 15, 2019 | K181534 | CIRRUS HD-OCT Carl Zeiss Meditec, Inc. | OBO |
| Jan 11, 2019 | K180229 | RESCAN 700, CALLISTO eye Carl Zeiss Meditec, AG, DE | OBO |
| Jan 10, 2019 | K181444 | CLARUS Carl Zeiss Meditec, Inc. | QER |
| Oct 25, 2018 | K181116 | CONVIVO Carl Zeiss Meditec, AG, DE | GWG |
| Oct 24, 2018 | K182318 | Retina Workplace Carl Zeiss Meditec, Inc. | NFJ |
| Aug 24, 2018 | K173771 | IOLMaster 700 Carl Zeiss Meditec, AG, DE | HJO |
| Jun 27, 2018 | K180858 | CALLISTO eye Carl Zeiss Meditec, AG, DE | NFJ |
| Jun 7, 2018 | K180839 | AT 030 Carl Zeiss Meditec, AG, DE | HKY |
| Apr 13, 2018 | K173371 | VisuMax Femtosecond Laser Carl Zeiss Meditec, Inc. | HNO |
| Aug 18, 2017 | K170667 | QEVO System with KINEVO 900 Carl Zeiss Meditec, AG, DE | GWG |
| Jul 24, 2017 | K162991 | YELLOW 560 Fluorescence Module Carl Zeiss Meditec, AG, DE | IZI |
| Jun 21, 2017 | K170638 | Retina Workplace Carl Zeiss Meditec, AG, DE | NFJ |
| May 31, 2017 | K162684 | SL 220 Carl Zeiss Meditec, AG, DE | HJO |
| Apr 6, 2017 | K170171 | IOLMaster 700 Carl Zeiss Meditec, AG, DE | HJO |
| Feb 23, 2017 | K161607 | VISULUX Carl Zeiss Meditec, AG, DE | HJO |
| Dec 15, 2016 | K162568 | INTRABEAM 600 Carl Zeiss Meditec, AG, DE | JAD |
| Oct 26, 2016 | K161194 | PLEX Elite 9000 SS-OCT Carl Zeiss Meditec, Inc. | OBO |
| Sep 1, 2015 | K150977 | CIRRUS HD-OCT Carl Zeiss Meditec, Inc. | OBO |
| Jul 10, 2015 | K143275 | IOLMaster700 Carl Zeiss Meditec, Inc. | HJO |
| May 21, 2015 | K150467 | Retina Workplace Carl Zeiss Meditec, AG, DE | NFJ |
| Nov 18, 2014 | K141844 | RESCAN 700, CALLISTO EYE Carl Zeiss Meditec, AG | OBO |
| Oct 3, 2014 | K141297 | FORUM GLAUCOMA WORKPLACE Carl Zeiss Meditec, AG | NFJ |
| Sep 9, 2014 | K141068 | ZEISS CATARACT SUITE MARKERLESS Carl Zeiss Meditec, AG | HJO |
| Mar 19, 2014 | K133217 | CIRRUS PHOTO Carl Zeiss Meditec, AG | OBO |
| Feb 12, 2014 | K133476 | SLIT LAMPS WITH SL CAM 5.0 DIGITAL IMAGING SOLUTION Carl Zeiss Meditec, AG | HJO |
| Jul 23, 2013 | K130648 | FORUM GLAUCOMA WORKPLACE Carl Zeiss Meditec, AG | NFJ |
| Jun 26, 2013 | K130549 | INTRABEAM FLAT APPLICATOR, INTRABEAM SURFACE APPLICATOR Carl Zeiss Meditec, Inc. | JAD |
Newest 50 of 77.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 1, 2026 | Carl Zeiss Meditec AG Zeiss Intrabeam Spherical Applicator 1.5 cm
REF:304534-6000-557 Open, Classified |
JAD | K121653 |
| Mar 16, 2022 | Carl Zeiss Meditec AG ZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000. Used during cataract surgery. Open, Classified |
HNQ | None listed |
| Jan 14, 2022 | Carl Zeiss Meditec, Inc. CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex Open, Classified |
OBO | K181534 |
| Jul 8, 2021 | Carl Zeiss Meditec, Inc. Chassis Label - "CIRRUS HD-OCT Rx-Only"
Product Label Exterior RX - "CIRRUS HD-OCT Model 6000" Open, Classified |
OBO | K181534 |
| Dec 7, 2020 | Carl Zeiss Meditec AG IOLMaster 700 Terminated |
HJO | K173771 |
| Aug 6, 2020 | Carl Zeiss Meditec AG Carl Zeiss Meditec AG VISUREF150 REF 2227-967 - Product Usage: is a diagnostic instrument used to determine the objective refractive values and keratometric characteristics of the human eye. The resul Terminated |
HKO | None listed |
| Aug 6, 2020 | Carl Zeiss Meditec AG Carl Zeiss Meditec Ag VISULENS 550 REF 2268-038 - Product Usage: is a device for measuring the refractive power of contact lenses and spectacle lenses and displaying measurement values for sphere, cyl Terminated |
HLM | None listed |
| Dec 6, 2018 | Carl Zeiss Meditec, Inc. VisuMax Software Version 2.10.13 with activated Software-Module ReLEx (SMILE) option used in conjunction with the VisuMax Femtosecond Laser System for Refractive Correction.
Catalog Number 0000000-13 Terminated |
OTL | None listed |
| Oct 16, 2018 | Carl Zeiss Meditec, Inc. The PLEX Elite 9000, a Swept-Source OCT [SS-OCT] - Product Usage: The PLEX Elite 9000 Swept-Source OCT [SS-OCT] is a non- contact, high resolution, wide field of view tomographic and biomicroscopic i Terminated |
OBO | K161194 |
| Jun 25, 2018 | Carl Zeiss Meditec AG Carl Zeiss Meditec AG, Goeschwitzer Strasse 51-52 07745 Jena, Germany,
IOLMaster 700, REF 1932-169
SN 1185393
2017-09-01 Terminated |
HJO | K170171 |
| Aug 30, 2017 | Carl Zeiss Meditec AG Carl Zeiss INTRABEAM PRS 500, product #304534-0000-500. The firm name on the label is Carl Zeiss Meditec AG, Jena, Germany.
The INTRABEAM System is indicated for radiation therapy treatments Terminated |
JAD | K051055 K090584 +3 |
| Dec 1, 2015 | Carl Zeiss Meditec AG IOL Master 500: Software versions 7.5 and 7.7;
Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white Terminated |
HJO | K101182 K122418 +1 |
| Dec 1, 2015 | Carl Zeiss Meditec AG IOL Master 5.5: Software versions 7.5 and 7.7;
Ophthalmic: used to obtain ocular measurements and perform calculations to allow physicians to determine appropriate IOL power and type for implantation Terminated |
HJO | K101182 K122418 +1 |
| Feb 4, 2015 | Carl Zeiss Meditec AG FORUM Archive and Viewer, version 3.1, v 3.1.1, (DVD Format) and v 3.2, v 3.2.1.(DVD and USB Flash Drive Format).
Catalog numbers: 000000-20107-750 (DVD with either FORUM v 3.1 or v 3.1.1)
000000-2 Terminated |
NFJ | K122938 |
| Mar 7, 2014 | Carl Zeiss Meditec AG Treatment packs used on the VisuMax Laser Keratome.
Size M
Manufactured by Carl Zeiss Meditec AG,
Jena, Germany.
The VisuMax Laser Keratome is indicated for the following: In the creation of a corne Terminated |
HQF | K100253 |
| Nov 15, 2013 | Carl Zeiss Meditec, Inc. Zeiss brand IOLMaster 500, Model 500, Biomicroscope, Slit-Lamp, AC-Powered,
Product is manufactured by Carl Zeiss Meditec AG (Jena),
Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Terminated |
HJO | K101182 K122418 +1 |
| Nov 15, 2013 | Carl Zeiss Meditec, Inc. Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered,
Product is manufactured by Carl Zeiss Meditec AG (Jena),
Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Ca Terminated |
HJO | K101182 K122418 +1 |
| May 31, 2013 | Carl Zeiss Meditec, Inc. Zeiss brand OPMI Pentero C, Surgical microscope and accessories, Model: OPMI Pentero C, Product Numbers: 302583-9001-000 (PENTERO C), and 305961-0000-00 (Ceiling Mount for PENTERO C),
Product Usage: Terminated |
EPT | None listed |
| Nov 20, 2012 | Carl Zeiss Meditec, Inc. INTRABEAM Balloon Applicator Set;
4.0 cm,
Carl Zeiss Meditec AG, Oberkochen, Germany
INTRABEAM System is intended for radiation therapy treatments. Terminated |
JAD | K090584 |
| Nov 20, 2012 | Carl Zeiss Meditec, Inc. INTRABEAM Balloon Applicator Set;
3.5 cm,
Carl Zeiss Meditec AG, Oberkochen, Germany
INTRABEAM System is intended for radiation therapy treatments. Terminated |
JAD | K090584 |
| Nov 20, 2012 | Carl Zeiss Meditec, Inc. INTRABEAM Balloon Applicator Set;
3.0 cm,
Carl Zeiss Meditec AG, Oberkochen, Germany
INTRABEAM System is intended for radiation therapy treatments Terminated |
JAD | K090584 |
| Oct 24, 2011 | Carl Zeiss Meditec, Inc. OPMI VARIO 700 Surgical Microscope.
Manufactured by: Carl Zeiss Meditec AG,
Oberkochen, Germany.
Provide a magnified view of the surgical field. Terminated |
EPT | None listed |
| Sep 23, 2011 | Carl Zeiss Meditec, Inc. OPMI Pentero, OPMI Pentero C, OPMI Pentero 900,
OPMI Vario/S8, OPMI Vario/S88, OPMI Neuro Multivision/NC4,
OPMI Vario/NC33, OPMI Neuro/NC4, OPMI Neuro/NC4 Ceiling Mount.
A surgical microscope and ac Terminated |
EPT | None listed |
| Aug 10, 2011 | Carl Zeiss Meditec, Inc. INTRABEAM Shielding Material Flat 20 x 20 cm,
Sterile/FO
0.05 mm Pb Equivalent (50keV)
Carl Zeiss Meditec AG
Indicated for radiation therapy treatments. Terminated |
JAD | K051055 K090584 |
| May 2, 2011 | Carl Zeiss Meditec Inc Cirrus HD-OCT Model 4000 instruments, new and refurbished, distributed with, or upgraded to, version v 1.0 - 4.5, 5.0.0 or 5.1.0
The Cirrus HD-OCT is a non-contact, high resolution tomographic and bio Terminated |
OBO | K083291 |
| May 2, 2011 | Carl Zeiss Meditec Inc Cirrus HD-OCT Model 400 instruments; new and refurbished, with or upgraded to, version 4.6 or 5.1.0 software.
The Cirrus HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging Terminated |
OBO | K083291 |
| Jan 14, 2011 | Carl Zeiss Meditec Inc VISU 200 on S8 Floor Stand, Manufactured by Carl Zeiss Surgical GmbH, Germany
Medical device: Surgical microscope used during ophthalmic surgeries, which allows real time visualization of the surgical Terminated |
EPT | None listed |
| Sep 3, 2009 | Carl Zeiss Meditec Inc Stratus OCT Model 3000 instruments distributed with version 6.0.0 software, product number 2660021119710 (new instrument) or 2660022119710 (refurbished instrument), and Stratus 6.0.0 Software Kit, pro Terminated |
HLI | K030433 K033123 |