Company ยท US
Meridian Co., Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2000 to 2024. Name variants (Inc, Corp, punctuation) are merged.
13510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GZO | Device, Galvanic Skin Response Measurement | 3 |
| HQF | Laser, Ophthalmic | 3 |
| GEX | Powered Laser Surgical Instrument | 2 |
| ILY | Lamp, Infrared, Therapeutic Heating | 2 |
| JOM | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic | 1 |
| LXS | Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla | 1 |
| NHN | Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 25, 2024 | K232417 | MR Q; MR Q SUPINE; MR Q SLT Meridian AG, CH | HQF |
| Sep 12, 2023 | K231011 | Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse Meridian AG, CH | HQF |
| May 19, 2017 | K160677 | MICRORUPTOR 6 Meridian AG, CH | GEX |
| Feb 14, 2012 | K113390 | LASER INDIRECT OPHTHALMOSCOPE 500(LIO-500) Meridian AG | GEX |
| Feb 25, 2011 | K102375 | LUCIA Meridian Co., Ltd. | ILY |
| Dec 29, 2008 | K081962 | LAPEX BCS Meridian Co., Ltd. | ILY |
| Dec 14, 2007 | K072823 | MERILAS 532A Meridian AG | HQF |
| Jan 21, 2005 | K034009 | LAPEX 2000 Meridian Co., Ltd. | NHN |
| Feb 19, 2003 | K023238 | MCPULSE Meridian Co., Ltd. | JOM |
| Sep 26, 2002 | K023045 | MICRORUPTER V Meridian AG, CH | LXS |
| Aug 29, 2002 | K020360 | ABR-2000 Meridian Co., Ltd., KR | GZO |
| Jun 19, 2001 | K010897 | MERIDIAN-PORTABLE Meridian Co., Ltd., KR | GZO |
| Nov 3, 2000 | K001347 | MERIDIAN-II AND MERDIAN-PLUS Meridian Co., Ltd., KR | GZO |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||