Data / Medical devices / Taiwan / Unimax Medical Systems Inc.
Unimax Medical Systems Inc.: FDA-registered device maker in New Taipei City, Taiwan, 6 510(k) clearances
Unimax Medical Systems Inc. is registered with the FDA (registration 3007791595) in New Taipei City, Taiwan. It lists 13 device types. The FDA files 6 510(k) clearances under its listings, the newest dated December 20, 2011. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3007791595
- Address
- 8F-2, No. 127, Lane 235, Pao Chiao Rd Xindian District, New Taipei City, Taiwan, 231
- Owner or operator
- Unimax Medical Systems Inc. (10028682)
- Roles
- Exporter to the US, Specification developer
- First device listed
- July 13, 2009
- Registered through
- 2027
- Brand names listed
- Insufflation Tubing Set, Irrigation Pump, Smoke Evacuation Tubing, Suction Irrigation Set, Suction Liner, Veress Needle, Wound Retractor, Yankauer suction probe
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 |
|---|---|---|---|---|---|---|
| December 20, 2011 | K103508 | UNMIAX LAPAROSCOPIC INSTRUMENT | GEI | Substantially Equivalent | Unimax Medical Systems, Inc. | accessdata.fda.gov |
| October 17, 2011 | K112358 | UNIMAX TROCAR SYSTEM | GCJ | Substantially Equivalent | Unimax Medical Systems, Inc. | accessdata.fda.gov |
| September 9, 2011 | K111622 | UNIMAX ANTI-FOG SOLUTION | OCT | Substantially Equivalent | Unimax Medical Systems, Inc. | accessdata.fda.gov |
| August 19, 2011 | K111441 | UNIMAX VERESS NEEDLE | HIF | Substantially Equivalent | Unimax Medical Systems, Inc. | accessdata.fda.gov |
| May 19, 2011 | K103509 | UNIMAX SUCTION IRRIGATION SET | GCJ | Substantially Equivalent | Unimax Medical Systems, Inc. | accessdata.fda.gov |
| May 6, 2011 | K103510 | UNIMAX SPECIMEN RETRIEVAL SYSTEM | GCJ | Substantially Equivalent | Unimax Medical Systems, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 25, 2024 | 95133 | Class II | Ongoing | 1. Tech Medical Services Inc. Detachable Endo Retrieval Pouch, REF TM2001, 3" x 6", sterile; 2. Tech Medical Services Inc. Detachable Endo Retrieval Pouch, REF TM2000, 5" x 7", sterile; 3. Tech Medical Services, Inc. Det | The tube may fall into the surgical site during the grasping process. | accessdata.fda.gov |
Compare with other makers
- All makers of Tubing/Tubing With Filter, Insufflation, Laparoscopic
- All makers of Guide, Needle, Surgical
- All makers of Bottle, Collection, Vacuum
- All makers of Laparoscope, General & Plastic Surgery
- All makers of Ring (Wound Protector), Drape Retention, Internal
- All makers of Pneumoperitoneum Needle
Updated September 17, 2024. 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.