Data is captured first-hand from the FDA / USPTO / EPO / JPO / TIPO official databases, then desensitized and synced to this page.
The same monitoring capability is split into two sub-systems: the Patent Monitoring System — automatically tracking patent status across Taiwan / US / EU / Japan; and the Intelligence Gathering System — automatically comparing the public US FDA records of major competitors. Every incumbent innovation and every public filing is first-hand intelligence for strengthening our product roadmap and white-space markets.
This system is not "patent news" — it is a live operations console directly tied to Maxima's operational risk and growth headroom. Three things matter most for investment judgment:
Bottom line: the "cleaner" the monitoring result (no WARNING / CRITICAL), the more stable Maxima's freedom to operate and competitive position. Once a high-severity alert appears, it signals that timelines, roadmap, or risk need re-assessment. The two sub-systems below handle "patent status" and "competitor FDA public records" respectively.
This list applies to both the Patent Monitoring System and the Intelligence Gathering System below — two views of the same set of parties: patent status and blocking vs. public FDA records.
The market is defined as the union of FDA (510(k) population) + CE-mark holders + NMPA China registrants. Key named rivals (the rest appear in the alert table and citation network below):
Keywords are defined first — Taiwan searches ultrasonic scalpel / transducer / handle / cutting / coagulation / bone blade / instrument / surgical; the US searches ultrasonic scalpel / blade / cautery / surgical / effector plus classifications A61B17/32 and A61B18/14. A record counts only if its title hits too. Caught does not mean relevant — reference only.
A monitored entity is a party we track (21 in total, merged across FDA·CE·NMPA tracks); an entity-layer target is the number of patents under those parties. Different things.
We look at who cites the incumbents' early patents: citing early = established rival; filing after those patents published and then citing = a new entrant coming in. This step only answers "who showed up" — not a blocking list; actual blocking requires a separate item-by-item comparison (see "blocking us now").
Automatically tracks patent status across Taiwan / US / EU / Japan: detects status changes, upcoming expiries, reinstatement windows and blocking events in real time. The figures below are synced from official patent databases; every record links back to the official page via "Verify".
Data is pulled automatically from the public databases of the Taiwan, US, European and Japanese patent offices and re-compared each cycle. This page connects to no internal database.
| Level | Time | Event | Patent | Patent holder | Title | Description | Verify |
|---|---|---|---|---|---|---|---|
| BLOCK | 2026-10-12 | Blocking patent | EP3263055B1 | Syntheon/Covidien(Medtronic) | — | Markets: DE, FR, GB; rights expiry: 2028-12-01 | Google Patents ↗ |
| BLOCK | 2026-10-12 | Blocking patent | US10799913B2 | COVIDIEN AG | — | Markets: US; rights expiry: 2032-01-13 | Google Patents ↗ |
| BLOCK | 2026-10-12 | Blocking patent | US8403949B2 | COVIDIEN AG | — | Markets: US; rights expiry: 2030-09-04 | Google Patents ↗ |
| BLOCK | 2026-10-12 | Blocking patent | US8461744B2 | CILAG GMBH INTERNATIONAL | — | Markets: US; rights expiry: 2029-09-11 | Google Patents ↗ |
| BLOCK | 2026-10-12 | Blocking patent | US11478820B2 | COVIDIEN AG | — | Markets: US; rights expiry: 2028-12-09 | Google Patents ↗ |
| BLOCK | 2026-10-12 | Blocking patent | EP2510891B1 | Covidien(Medtronic) | — | Markets: GB, DE, FR; rights expiry: 2032-04-15 | Google Patents ↗ |
| BLOCK | 2026-10-12 | Blocking patent | EP2422721B1 | Covidien(Medtronic) | — | Markets: GB, DE, FR, AT; rights expiry: 2031-08-25 | Google Patents ↗ |
| BLOCK | 2026-10-12 | Blocking patent | EP2453813B1 | Covidien(Medtronic) | — | Markets: GB, DE, FR; rights expiry: 2030-07-10 | Google Patents ↗ |
| BLOCK | 2026-10-12 | Blocking patent | EP3263054B1 | Covidien(Medtronic) | — | Markets: GB, DE, FR; rights expiry: 2030-07-10 | Google Patents ↗ |
| BLOCK | 2026-10-12 | Blocking patent | EP3524189B1 | Covidien(Medtronic) | — | Markets: GB, DE, FR; rights expiry: 2030-07-10 | Google Patents ↗ |
| BLOCK | 2026-10-12 | Blocking patent | EP2229104B1 | Syntheon/Covidien(Medtronic) | — | Markets: GB, DE, FR, AT; rights expiry: 2028-12-01 | Google Patents ↗ |
| BLOCK | 2026-10-12 | Blocking patent | EP2433577B1 | Syntheon/Covidien(Medtronic) | — | Markets: GB, DE, FR; rights expiry: 2028-12-01 | Google Patents ↗ |
| BLOCK | 2026-10-12 | Blocking patent | EP2433578B1 | Syntheon/Covidien(Medtronic) | — | Markets: GB, DE, FR; rights expiry: 2028-12-01 | Google Patents ↗ |
| BLOCK | 2026-10-12 | Blocking patent | EP3398540B1 | Covidien(Medtronic) | — | Markets: DE, FR, AT; rights expiry: 2031-08-25 | Google Patents ↗ |
| BLOCK | 2026-10-12 | Blocking patent | AU2008334050B2 | Syntheon/Covidien(Medtronic) | — | Markets: AU; rights expiry: 2028-12-01 | Google Patents ↗ |
| BLOCK | 2026-10-12 | Blocking patent | AU2013207564B2 | Covidien(Medtronic) | — | Markets: AU; rights expiry: 2028-12-01 | Google Patents ↗ |
| BLOCK | 2026-10-12 | Blocking patent | AU2017203336B2 | Covidien(Medtronic) | — | Markets: AU; rights expiry: 2031-08-24 | Google Patents ↗ |
| BLOCK | 2026-10-12 | Blocking patent | JP6081561B2 | Ethicon(J&J) | — | Markets: JP; rights expiry: To be verified | Google Patents ↗ |
| BLOCK | 2026-10-12 | Blocking patent | US9414853 | ETHICON ENDO-SURGERY, INC. | — | Markets: US; rights expiry: To be verified | Google Patents ↗ |
| BLOCK | 2026-10-12 | Blocking patent | US9168055 | Ethicon Endo-Surgery, Inc. | — | Markets: US; rights expiry: To be verified | Google Patents ↗ |
| BLOCK | 2026-10-12 | Blocking patent | US9724120 | Ethicon Endo-Surgery, Inc. | — | Markets: US; rights expiry: To be verified | Google Patents ↗ |
Major competitors' public records at the US FDA — MAUDE adverse events, recalls, 510(k) clearances, GUDID listings / delistings, establishment registrations & device listings, enforcement reports and warning letters — compared automatically each cycle.
The panel below is the intelligence system at a glance: current record counts per source, the alerts surfaced in the latest comparison, and known limits; every alert links to the official query for verification.
Rows are the latest official record in each source, limited to ultrasonic-scalpel products (brands HARMONIC / SONICISION / THUNDERBEAT, product codes LFL / GEI / NLQ, or an ultrasonic-description match for enforcement reports); records that cannot be confirmed as ultrasonic-scalpel are omitted. Rows after those are the alerts surfaced in the latest intelligence comparison (event types shown as plain-language names). Levels are a display convention (Warning letter = WARNING; recall / enforcement / GUDID withdrawn / alert = NOTICE; others = INFO), not our assessment. Click a row's link to open the official query and verify. This table contains no assessment or interpretation by us. Retrieved at 2026-10-22T09:27:11.
| Level | Event type | Content |
|---|---|---|
| INFO | MAUDE events | J&J/Ethicon(Harmonic) · HARMONIC · 2026-09-30 · 編號 3005075853-2026-08108 official query ↗ |
| NOTICE | Recalls | J&J/Ethicon(Harmonic) · LFL · 2021-07-20 · 編號 Z-2355-2021 official query ↗ |
| INFO | 510(k) clearance | J&J/Ethicon(Harmonic) · GEI · 2026-09-17 · 編號 K254196 official query ↗ |
| INFO | GUDID listed | J&J/Ethicon(Harmonic) · Harmonic · 2024-03-01 · 編號 HAR745 official query ↗ |
| NOTICE | GUDID withdrawn | J&J/Ethicon(Harmonic) · Harmonic · 2023-04-04 · 編號 HST01 official query ↗ |
| NOTICE | Enforcement | J&J/Ethicon(Harmonic) · HARMONIC HD 1000i Shears (20cm Shaft Length) · 2021-09-01 · 編號 Z-2355-2021 official query ↗ |
| INFO | MAUDE events | Medtronic/Covidien(Sonicision) · SONICISION · 2026-09-30 · 編號 1717344-2026-01343 official query ↗ |
| NOTICE | Recalls | Medtronic/Covidien(Sonicision) · GEI · 2023-11-16 · 編號 Z-0631-2024 official query ↗ |
| INFO | 510(k) clearance | Medtronic/Covidien(Sonicision) · GEI · 2026-09-15 · 編號 K261070 official query ↗ |
| INFO | GUDID listed | Medtronic/Covidien(Sonicision) · Sonicision · 2022-09-22 · 編號 SCD391 official query ↗ |
| NOTICE | GUDID withdrawn | Medtronic/Covidien(Sonicision) · Sonicision · 2025-09-18 · 編號 SCT12 official query ↗ |
| NOTICE | Enforcement | Medtronic/Covidien(Sonicision) · Covidien Sonicision Battery Charger-intended · 2021-12-15 · 編號 Z-0332-2022 official query ↗ |
| WARNING | Warning letters | Medtronic/Covidien(Sonicision) · SONICISION · 2021-12-28 · 編號 12/28/2021 official query ↗ |
| INFO | MAUDE events | Olympus(Thunderbeat) · THUNDERBEAT · 2026-09-28 · 編號 9614641-2026-00962 official query ↗ |
| NOTICE | Recalls | Olympus(Thunderbeat) · GEI · 2026-08-18 · 編號 Z-3035-2026 official query ↗ |
| INFO | 510(k) clearance | Olympus(Thunderbeat) · GEI · 2026-07-01 · 編號 K254056 official query ↗ |
| INFO | GUDID listed | Olympus(Thunderbeat) · THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 45cm · 2025-12-04 · 編號 TB2-0545FC official query ↗ |
| NOTICE | GUDID withdrawn | Olympus(Thunderbeat) · THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip · 2025-11-24 · 編號 TB-0520FC official query ↗ |
| NOTICE | Enforcement | Olympus(Thunderbeat) · Olympus Thunderbeat II Shears w/Ultrasonic M · 2026-04-29 · 編號 Z-1854-2026 official query ↗ |
| WARNING | Warning letters | Olympus(Thunderbeat) · THUNDERBEAT · 2026-10-20 · 編號 10/20/2026 official query ↗ |
| NOTICE | Recalls | Stryker · GEI · 2026-06-08 · 編號 Z-2865-2026 official query ↗ |
| INFO | 510(k) clearance | Stryker · LFL · 2026-10-08 · 編號 K262244 official query ↗ |
| INFO | GUDID listed | Stryker · 超音波刀(描述命中) · 2024-03-04 · 編號 HAR1136 official query ↗ |
| NOTICE | GUDID withdrawn | Stryker · SonicFusion · 2024-12-16 · 編號 0019102000 official query ↗ |
| NOTICE | Enforcement | Stryker · HARMONIC FOCUS Shears + Adaptive Tissue Tech · 2025-11-19 · 編號 Z-0490-2026 official query ↗ |
| NOTICE | Recalls | Integra/Misonix(CUSA) · LFL · 2026-03-06 · 編號 Z-1828-2026 official query ↗ |
| INFO | 510(k) clearance | Integra/Misonix(CUSA) · LFL · 2026-07-30 · 編號 K261448 official query ↗ |
| INFO | GUDID listed | Integra/Misonix(CUSA) · neXus · 2020-02-24 · 編號 100-10-0000 official query ↗ |
| NOTICE | GUDID withdrawn | Integra/Misonix(CUSA) · CUSA® NXT · 2024-11-20 · 編號 NXT3219 official query ↗ |
| NOTICE | Enforcement | Integra/Misonix(CUSA) · CUSA Clarity C7000 Console, Software Version · 2026-04-29 · 編號 Z-1828-2026 official query ↗ |
| INFO | 510(k) clearance | SRA Developments(LOTUS) · LFL · 2022-12-15 · 編號 K221102 official query ↗ |
| NOTICE | Recalls | Tenex Health/Trice Medical · LFL · 2014-04-14 · 編號 Z-1552-2014 official query ↗ |
| INFO | 510(k) clearance | Tenex Health/Trice Medical · LFL · 2024-11-18 · 編號 K241700 official query ↗ |
| NOTICE | Enforcement | Tenex Health/Trice Medical · TX1 Tissue Removal System. TX1 Procedure Pa · 2014-05-14 · 編號 Z-1552-2014 official query ↗ |
| INFO | 510(k) clearance | Erbe · GEI · 2025-12-18 · 編號 K253915 official query ↗ |
| NOTICE | Clinical-pain keyword surge | [Harmonic (Ethicon)] 臨床痛點關鍵詞升溫:BROKEN TIP(刀頭斷裂) 近 12 個月(20250623~20260623)命中 19 件,前一期同長度窗口 7 件(比值 2.71)。⚠ MAUDE 多為原廠自通報(Harmonic 全期 OTHER 47,595 件 vs PHYSICIAN 1,961 件),此為競品自家客訴帳之變化,宜與失效模式碼併讀。 official query ↗ |
One-line explanations of the agencies and public-record terms appearing on this page.
The above are term definitions based on each agency's public information; this page does not judge the cause of any individual recall, report or letter.