510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

Unimax Medical Systems Inc.

New Taipei City, TW

UNIMAX MEDICAL SYSTEMS INC. appears in FDA device records in New Taipei City, TW. FDA records list 7 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
7
PMA records
0
Recall records
1
Registered establishments
2

510(k) clearance history

FDA records hold 7 510(k) clearances for Unimax Medical Systems Inc. between 2011 and 2021. The busiest year on record is 2011, with 6. The most recent is 2021, with 1.

Clearances by year, as a table
510(k) clearance decisions for Unimax Medical Systems Inc., by decision year
YearClearances
20116
20211
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K211577SoftFix Balloon TrocarGCJSubstantially Equivalent
K103508UNMIAX LAPAROSCOPIC INSTRUMENTGEISubstantially Equivalent
K112358UNIMAX TROCAR SYSTEMGCJSubstantially Equivalent
K111622UNIMAX ANTI-FOG SOLUTIONOCTSubstantially Equivalent
K111441UNIMAX VERESS NEEDLEHIFSubstantially Equivalent
K103509UNIMAX SUCTION IRRIGATION SETGCJSubstantially Equivalent
K103510UNIMAX SPECIMEN RETRIEVAL SYSTEMGCJSubstantially Equivalent

Registered establishments

FDA registered establishments for Unimax Medical Systems Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30077915953007791595UNIMAX MEDICAL SYSTEMS INC.8F-2, No. 127, Lane 235, Pao Chiao Rd, New Taipei City 231 TW2026and 3 more, listed in full below
30154974243015497424UNIMAX MEDICAL SYSTEMS INC.No. 37, Sec. 2, Ligong 1st Rd., Wujie Township, Yilan County 26841 TW2026and 3 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-3164-20241. 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. Detachable Endo Retrieval Pouch, REF TM2002, 8" x 10", sterile; 4. UNIMAX Detachable endo pocket, REF FEP936116, 3" x 6", sterile; 5. UNIMAX Detachable endo pocket, REF FEP979000, 8" x 10", sterile; 6. ConMed Corporation Detachable endo pocket, REF SB936, 3" x 6", sterile; 7. ConMed Corporation Detachable endo pocket, REF SB957, 5" x 7", sterile; 8. ConMed Corporation Detachable endo pocket, REF SB979, 7.5" x 9", sterile; 9. ConMed Corporation Detachable endo pocket, REF SB979-CA, 7.5 x 9", sterile; 10. ConMed Corporation Detachable endo pocket, REF SB936-CA, 3" x 6", sterile;The tube may fall into the surgical site during the grasping process.Class IIOpen, Classified

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

MDM coverage of this company lists here, newest first. Submit news.

Is this your company?

This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.

Claiming lets Unimax Medical Systems Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

Claim this page

Data as of , FDA export datePage updated Source: openFDA, public domain