Nidek Inc.
Nidek Inc. appears in FDA public data with 21 recalls, 77 510(k) clearances, 7 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-0771-2020, Class III) was initiated on February 25, 2019. Its most recent 510(k) clearance was granted on August 24, 2005.
Summary
- Total Recalls
- 21
- 510(k) Clearances
- 77
- Inspections
- 7
- Compliance Actions
- 1
Known Names
nidek, nidek co
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0771-2020 | Class III | NIDEK Specular Microscope, Model CEM-530 - Product Usage: The device provides noncontact, high magni | February 25, 2019 |
| Z-0655-2019 | Class III | RT-5100 Refractor, a component of the Epic-5100 System. | June 14, 2018 |
| Z-1348-2018 | Class II | AUTO REF/KERATOMETER ARK-1s | December 20, 2017 |
| Z-1494-2017 | Class II | Final Fit Software Version 1.11 and 1.12; PC Based software installed outside Nidek EC-5000 Excime | February 1, 2017 |
| Z-2711-2016 | Class II | SPECULAR MICROSCOPE CEM-530; Software version 1.08 and 1.09. Opthalmic: The NIDEK Specular Micros | August 8, 2016 |
| Z-2587-2016 | Class II | OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier. Ophthalmic: The OPTICAL BIOMETER AL | July 1, 2016 |
| Z-1245-2016 | Class II | RT-5100 (Epic 5100) Refractor and RT 3100 Refractor: Product Usage: Instrument providing means o | February 29, 2016 |
| Z-2477-2015 | Class II | OPD-Scan III Refractive Power/Corneal Analyzer Opthalmic Software versions 1.00.08 1.05.07 1.10.01, | June 15, 2015 |
| Z-2068-2015 | Class II | Endophotocoagulation Delivery 4EP-1 of GYC-1000 Green Laser Photocoagulator System; GYC4EP-01 0W02 | March 25, 2015 |
| Z-2067-2015 | Class II | Dual Delivery 4DD-1 of GYC-1000 Green Laser Photocoagulator system GYC4DD-1: The Nidek Green Las | March 25, 2015 |
| Z-1710-2015 | Class II | EC-5000 Excimer Laser Corneal Surgery System (EC-5000, EC 5000 CXIII, EC-5000 Quest. Opthalmic: N | March 24, 2015 |
| Z-1367-2015 | Class II | YC-1800 OPHTHALMIC YAG LASER SYSTEM; The YC-1800 allows the safe and bloodless treatment of intra | March 6, 2015 |
| Z-1980-2014 | Class II | Non-Mydriatic Auto Fundus Camera. Model AFC-330. An ophthalmic camera for use in capturing images o | June 16, 2014 |
| Z-1853-2014 | Class II | RT-5100 Refractor and RT-3100 Refractor; Distributed by MARCO Opthalmic: Manufactured by NIDEK C | June 9, 2014 |
| Z-2132-2014 | Class II | MC-500 Multicolor Laser Photocoagulator; Distributed by NIDEK Inc. Manufactured by NIDEK CO., Ltd, | June 9, 2014 |
| Z-2120-2014 | Class II | GYC-1000 Green Laser Photocoagulator system The Nidek Green Laser Photocoagulator Model GYC -1000 | May 16, 2014 |
| Z-2046-2013 | Class II | NAVIS-EX , Image Filing Software for NIDEK AFC Fundus camera, Ver 1.1.0 to 1.3.5. NAVIS-EX is indica | August 1, 2013 |
| Z-0222-2015 | Class II | MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic device used for reti | May 24, 2013 |
| Z-0224-2015 | Class II | Nidek MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic Device. The Ni | October 24, 2012 |
| Z-0223-2015 | Class II | Nidek Excimer Laser Corneal Surgery System, model EC-5000 CXIII. Opthalmic Device. The system is co | August 6, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K050336 | OPD-STATION SOFTWARE | August 24, 2005 |
| K042785 | MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-300 | December 14, 2004 |
| K031733 | NON-CONTACT TONOMETER, MODEL NT-4000 | December 4, 2003 |
| K032085 | GREEN LASER PHOTOCOAGULATOR MODEL GYC-1000 | October 3, 2003 |
| K013694 | NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS) | November 19, 2002 |
| K020876 | ECHOSCAN, MODEL US-1800 | May 3, 2002 |
| K014274 | NON-MYDRIATIC FUNDUS CAMERA, MODEL NM-1000 | April 17, 2002 |
| K013760 | DC-3300 LASER DIODE PHOTOCOAGULATOR | February 11, 2002 |
| K013864 | MODIFICATION TO EPI-STAR SURGICAL LASER SYSTEM, M0DEL DS-60 | February 8, 2002 |
| K990119 | EPI-STAR SURGICAL LASER SYSTER | July 27, 2000 |
| K990900 | MICROKERATOME, MODEL MK-2000 | September 24, 1999 |
| K991284 | ANTERIOR EYE-SEGMENT ANALYSIS SYSTEM | August 6, 1999 |
| K980475 | UNIPULSE CO2 SURGICAL LASER SYSTEM | December 16, 1998 |
| K982295 | NIDEK LIGHTSCAN | August 6, 1998 |
| K981447 | DIO-LIGHT 60 LASER SYSTEM | June 5, 1998 |
| K980547 | NIDEK PRIMA MODEL GYC-1500/2000 | May 13, 1998 |
| K974732 | NIDEK MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-7000 | March 18, 1998 |
| K980201 | DIO-LIGHT LASER SYSTEM | March 16, 1998 |
| K973828 | PRIMA KTP LASER SYSTEM | January 5, 1998 |
| K973533 | NIDEK STEREO DISC CAMERA(3-DX)/NIDEK STEREO FUNDUS CAMERA(3-DXF) | November 4, 1997 |