FDA Device Registration & Listing · GILCHING Bavaria, DE · Registration 1000379039
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| HPP | Headlamp, Operating, Battery-Operated | Ophthalmic | Class 1 | 886.4335 | 2008-06-25 |
| HLJ | Ophthalmoscope, Battery-Powered | Ophthalmic | Class 2 | 886.1570 | 2013-03-26 |
| HLJ | Ophthalmoscope, Battery-Powered | Ophthalmic | Class 2 | 886.1570 | 2013-03-05 |
| HLI | Ophthalmoscope, Ac-Powered | Ophthalmic | Class 2 | 886.1570 | 2013-03-05 |
| FER | Anoscope And Accessories | Gastroenterology, Urology | Class 2 | 876.1500 | 2007-11-12 |
| HLI | Ophthalmoscope, Ac-Powered | Ophthalmic | Class 2 | 886.1570 | 2007-11-29 |
| HJM | Transilluminator, Ac-Powered | Ophthalmic | Class 2 | 886.1945 | 2008-04-03 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Cardiovascular | Class 2 | 870.1130 | 2007-11-29 |
| LDE | Stethoscope, Manual | Cardiovascular | Class 1 | 870.1875 | 2004-06-02 |
| HOX | Chart, Visual Acuity | Ophthalmic | Class 1 | 886.1150 | 2004-06-02 |
| HMF | Stand, Instrument, Ac-Powered, Ophthalmic | Ophthalmic | Class 1 | 886.1860 | 2013-01-14 |
| FMA | Depressor, Tongue, Non-Surgical | General Hospital | Class 1 | 880.6230 | 1991-08-08 |
| KYT | Light, Examination, Medical, Battery Powered | General Hospital | Class 1 | 880.6350 | 2008-04-29 |
| HJL | Lens, Condensing, Diagnostic | Ophthalmic | Class 1 | 886.1380 | 2004-06-02 |
| GCM | Endoscope, Rigid | Gastroenterology, Urology | Class 2 | 876.1500 | 2007-11-30 |
| EPY | Speculum, Ent | General, Plastic Surgery | Class 1 | 878.1800 | 2004-06-02 |
| HLJ | Ophthalmoscope, Battery-Powered | Ophthalmic | Class 2 | 886.1570 | 2015-06-19 |
| HKM | Retinoscope, Battery-Powered | Ophthalmic | Class 1 | 886.1780 | 2004-06-02 |
| CCW | Laryngoscope, Rigid | Anesthesiology | Class 1 | 868.5540 | 2004-06-02 |
| HLJ | Ophthalmoscope, Battery-Powered | Ophthalmic | Class 2 | 886.1570 | 2015-06-19 |
| KZF | Device, Medical Examination, Ac Powered | General Hospital | Class 1 | 880.6320 | 2010-04-23 |
| HJN | Transilluminator, Battery-Powered | Ophthalmic | Class 1 | 886.1945 | 2008-04-03 |
| DXQ | Blood Pressure Cuff | Cardiovascular | Class 2 | 870.1120 | 2010-09-24 |
| HJH | Loupe, Binocular, Low Power | Ophthalmic | Class 1 | 886.5120 | 2004-06-02 |
No official correspondent registered.
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K142953 | Optomedical Technologies GmbH | OCT-Camera | 2015-03-04 |
| K100940 | Andon Health Co, Ltd. | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965 | 2010-06-29 |
| K251581 | Shenzhen Hingmed Medical Instrument Co., Ltd. | Wearable Ambulatory Blood Pressure Monitor (WBP-02A) | 2026-02-13 |
| K200521 | Health & Life Co., Ltd. | Full Automatic(NIBP) Blood Pressure Monitor | 2020-06-12 |
| K152003 | Andon Health Co, Ltd. | iHealth BP3L Wireless Blood Pressure Monitor | 2015-09-24 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0008-2018 | Optovue, Inc. | 2 | iVue with Normative Database, Device Listing Number D185549.
Product Usage: The iVue (K121739) is a non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional, and three dimensional imaging and measurement of anterior and posterior ocular
structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue with Normative Database is a quantitative tool for the comparison of
retina, retinal nerve fiber layer, ganglion cell complex, and optic disc
measurements to a database of known normal subjects. The iVue with Normative Database is indicated for use as a device to aid in the diagnosis, documentation, and management of ocular health and diseases in the adult population. |
| Z-0010-2018 | Optovue, Inc. | 2 | iVue 500 with iScan, D216606.
Product non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional and three-dimensional imaging and measurement of anterior and posterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue 500 with normative database is a quantitative tool for the comparison of retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects. The iVue 500 with normative database is indicated for use as a device to aid in the diagnosis,
documentation, and management of ocular health and diseases in the adult population. |
| Z-0032-2025 | MEDLINE INDUSTRIES, LP Northfield | 2 | MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001 |
| Z-0033-2025 | MEDLINE INDUSTRIES, LP Northfield | 2 | MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U. |
| Z-0034-2025 | MEDLINE INDUSTRIES, LP Northfield | 2 | MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3013682780 | RONIN SURGICAL CORP. | Austin, TX, US |
| 3035371773 | Rocoto Inc. | Irvine, CA, US |
| 3006993514 | AboCom Systems, Inc. | Zhunan Township Miaoli, TW |
| 3014342096 | KARL STORZ SE & CO KG | TUTTLINGEN Baden-Wurttemberg, DE |
| 3007662989 | DENTMATE TECHNOLOGY CO., LTD. | New Taipei, TW |
1000379039 when referencing this establishment in official correspondence.