Company ยท US
Neocis, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2016 to 2026. Name variants (Inc, Corp, punctuation) are merged.
19510(k) clearances (1 in 12 months)
5recalls (0 in 12 months)
5recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 13, 2026 | K261321 | Yomi S Robotic System Neocis, Inc. | QRY |
| Oct 28, 2025 | K252376 | Yomi S Robotic System Neocis, Inc. | PLV |
| Oct 10, 2025 | K251835 | Yomi Robotic System Neocis, Inc. | PLV |
| Aug 14, 2023 | K231018 | Yomi Robotic System Neocis, Inc. | PLV |
| Dec 8, 2022 | K222750 | Yomi Robotic System Neocis, Inc. | QRY |
| Nov 4, 2022 | K222049 | Yomi Robotic System Neocis, Inc. | QRY |
| Jun 14, 2022 | K211466 | Yomi Robotic System with YomiPlan Go Neocis, Inc. | PLV |
| Dec 22, 2021 | K210711 | Neocis Guidance System (NGS) with Yomi Plan v2.0.1 Neocis, Inc. | PLV |
| Jul 28, 2021 | K211129 | Neocis Guidance System (NGS) with Intraoral Fiducial Array Neocis, Inc. | PLV |
| Dec 15, 2020 | K203401 | Neocis Guidance System (NGS) with Patient Splints (EPS) Neocis, Inc. | PLV |
| Dec 4, 2020 | K202264 | Neocis Guidance System (NGS) with Yomi Plan v2.0 Neocis, Inc. | PLV |
| Oct 19, 2020 | K202100 | Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS) Neocis, Inc. | PLV |
| Jul 28, 2020 | K200805 | Neocis Guidance System (NGS) with Patient Splints Neocis, Inc. | PLV |
| May 8, 2020 | K200348 | Neocis Guidance System (NGS) with Fiducial Array Splint (FAS) Neocis, Inc. | PLV |
| Oct 2, 2019 | K191363 | Neocis Planning Software Application (NPSA) for 3rd Party PCs Neocis, Inc. | PLV |
| Sep 11, 2019 | K191605 | Neocis Guidance System (NGS) Neocis, Inc. | PLV |
| Dec 21, 2018 | K182776 | Neocis Guidance System Neocis, Inc. | PLV |
| Feb 22, 2018 | K173402 | Neocis Guidance System (NGS) with Chairside Splint Neocis, Inc. | PLV |
| Dec 22, 2016 | K161399 | Neocis Guidance System Neocis, Inc. | PLV |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 30, 2020 | Neocis, Inc. DRW-0739-01:Gen 2 Anterior Chairside Splint LRUL (lower right-upper left); accessories to the parent system, the Neocis Guidance System (NGS) Terminated |
PLV | K173402 |
| May 14, 2020 | Neocis Inc. DRW-0742-01: Gen 2 Anterior Chairside Splint LLUR (lower left-upper right) - Product Usage: intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phase Terminated |
PLV | K173402 |
| May 14, 2020 | Neocis Inc. DRW-0739-02: Gen 2 Posterior Chairside Splint LRUL (lower right-upper left) - Product Usage: intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phas Terminated |
PLV | K173402 |
| May 14, 2020 | Neocis Inc. DRW-0739-01: Gen 2 Posterior Chairside Splint LLUR (lower left-upper right) - Product Usage: intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phas Terminated |
PLV | K173402 |
| Oct 4, 2019 | Neocis Inc. Neocis Guidance System Fiducial Array - Product Usage: The Neocis Guidance System (NGS) is a computerized navigational system intended to provide assistance in both the planning (pre-operative) and th Terminated |
PLV | K161399 |