Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in JapanLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Nakanishi Inc. and its 1 subsidiaries with 53 510(k) clearances and 11 device recalls. The most recent is a 510(k) clearance dated Mar 10, 2026: Varios Combi Pro2.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Nakanishi Inc. and its 1 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Mar 10, 2026 | Varios Combi Pro2K260773 · ELC | 510(k) clearances |
| Dec 23, 2025 | VarioSurg 4K254163 · DZI | 510(k) clearances |
| Sep 19, 2025 | VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11)K251689 · ELC | 510(k) clearances |
| Sep 19, 2025 | UniBurK252662 · HBE | 510(k) clearances |
| Sep 20, 2024 | Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip)K241880 · EFB | 510(k) clearances |
| Jun 24, 2024 | NLZ Built-In Motor SystemK233288 · EBW | 510(k) clearances |
| Jun 20, 2024 | Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT)K233117 · EBW | 510(k) clearances |
| Apr 25, 2024 | Air Motor (Model name: FX204 M4); Air Motor (Model name: M205)K233308 · EFB | 510(k) clearances |
| Jun 1, 2018 | Surgical Handpiece, Model: SGS-E, Order Code: H084, Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. TypicaClass II · Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and | Device recalls |
| Jun 1, 2018 | Surgical Handpiece, Model: SGA-E Order Code: H083, Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. TypicClass II · Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and | Device recalls |
| Jun 1, 2018 | Micro Surgery Handpiece SGS, Model: SGS-E2S, Order Code: H266, Manufactured by: Nakanishi Inc The SGS/SGA Surgical Handpieces are intendClass II · Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and | Device recalls |
| Jun 1, 2018 | Micro Surgery Handpiece SGA, Model SGA-ES, Order Code:H263, Manufactured by: Nakanishi Inc. The SGS/SGA Surgical Handpieces are inteClass II · Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and | Device recalls |
| Jun 1, 2018 | Micro Surgery Handpiece SGS, Model: SGS-ES, Order Code: H264, Manufactured by: Nakanishi Inc. The SGS/SGA Surgical Handpieces are intendClass II · Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and | Device recalls |
| Jun 1, 2018 | Surgical Handpiece, Model: SGA-E2G Order Code: H184, Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. TypClass II · Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and | Device recalls |
| Jun 1, 2018 | Surgical Handpiece, Model: SGS-E2G Order Code: H185, Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. TypicClass II · Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and | Device recalls |
| Jun 1, 2018 | Micro Surgery Handpiece SGA, Model SGA-E2S Order Code: H265, Manufactured by: Nakanishi Inc. The SGS/SGA Surgical Handpieces are intenClass II · Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
