Data / Medical devices / Taiwan / New Deantronics Taiwan Ltd.
New Deantronics Taiwan Ltd.: FDA-registered device maker in New Taipei City, Taiwan, 11 510(k) clearances
New Deantronics Taiwan Ltd. is registered with the FDA (registration 9681191) in New Taipei City, Taiwan. It lists 14 device types. The FDA files 11 510(k) clearances under its listings, the newest dated October 1, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9681191
- FEI number
- 3008207730
- Address
- 12F. No.51, Sec. 4, Zhongyang Rd. Tucheng Dist., New Taipei City, Taiwan, 236
- Owner or operator
- NEW DEANTRONICS TAIWAN LTD. (9020358)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- December 20, 2007
- Registered through
- 2027
- Brand names listed
- Claria BTR, Clearmind Axonpen, Clearmind ClearPath, Coated Electrodes, Dist Rib Clear cannula with oburator, ESU Grounding pad - Adult Pad, Hawkeye Control Unit with Eyas Endoscope, Infant Return Pad and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 1, 2025 | K251899 | E Blator | GEI | Substantially Equivalent | New Deantronics Taiwan , Ltd. | accessdata.fda.gov |
| November 20, 2020 | K202962 | Smoke Evacuation Button Switch Pencil, Non-Ext., 10ft, D1, Smoke Evacuation Button Switch Pencil, Non-Ext., 15ft, D1, Smoke Evacuation Button Switch Pencil, Non-Ext., 10ft, D2, Smoke Evacuation Button Switch Pencil, Non-Ext., 15ft, D2, Telescopic Smoke Evacuation Button Switch Pencil, 10ft, Telescopic Smoke Evacuation Button Switch Pencil, 15ft, Telescopic Smoke Evacuation Button Switch Pencil, 15ft, Telescopic Smoke Evacuation Button Switch Pencil, Lock, 15ft | GEI | Substantially Equivalent | New Deantronics Taiwan , Ltd. | accessdata.fda.gov |
| September 28, 2020 | K201221 | Electrosurgical Generator | GEI | Substantially Equivalent | New Deantronics Taiwan , Ltd. | accessdata.fda.gov |
| October 24, 2006 | K061878 | ELECTRODE COATED BALL, MODEL AB302C; NEEDLE, MODEL AN301C; BLADE, MODEL AE301HC | GEI | Substantially Equivalent | E Surgical, LLC | accessdata.fda.gov |
| March 31, 2006 | K060255 | E SURGICAL ELECTROSURGICAL PATIENT RETURN ELECTRODE, DUAL PLATE WITH CORD AND ELECTROSURGICAL PATIENT RETURN ELECTRODE | GEI | Substantially Equivalent | E Surgical, LLC | accessdata.fda.gov |
| November 3, 1998 | K982748 | BI-POLAR CORD SET 1.88 TR, BI-POLAR CORD SET 1.83 TR, MODEL #'S SB223, SB 224 | GEI | Substantially Equivalent | New Deantronics Taiwan , Ltd. | accessdata.fda.gov |
| September 14, 1998 | K982884 | DISPOSABLE HAND SWITCHING PENCIL, ROCKER SWITCH TWO PIECE, SB 312RS, TWO DISPOSABLE HAND SWITCHING PENCIL, ROCKER SWITCH | GEI | Substantially Equivalent | New Deantronics, Ltd. | accessdata.fda.gov |
| September 14, 1998 | K982746 | MONOPOLAR SUCTION COAGULATOR, MODEL # SB 110-1 | GEI | Substantially Equivalent | New Deantronics Taiwan , Ltd. | accessdata.fda.gov |
| September 14, 1998 | K982742 | DISPOSABLE HAND SWITCHING PENCIL, ROCKER SWITCH, ONE PIECE AND ONE PIECE HOLSTER MODELS SB 313 RS, SB 313 RSH | GEI | Substantially Equivalent | New Deantronics Taiwan , Ltd. | accessdata.fda.gov |
| September 11, 1998 | K982744 | DISPOSABLE HAND SWITCHING PENCIL, PUSH BUTTON, 2 PIECE WITH AND WITHOUT HOLSTER, MODELS SB 312PB, SB 312 PBH | GEI | Substantially Equivalent | New Deantronics Taiwan , Ltd. | accessdata.fda.gov |
| August 7, 1998 | K982130 | RETURN ELECTRODE CLAMP SHELL CORD MODEL RC 201 | GEI | Substantially Equivalent | New Deantronics, Ltd. | accessdata.fda.gov |
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Updated October 1, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.