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Data / Medical devices / Singapore / Venner Medical (singapore) Pte Ltd

Venner Medical (singapore) Pte Ltd: FDA-registered device maker in Singapore Central Singapore, Singapore, 3 510(k) clearances

Venner Medical (singapore) Pte Ltd is registered with the FDA (registration 3007740622) in Singapore Central Singapore, Singapore. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated July 28, 2011. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3007740622
Address
35 Joo Koon Circle, Singapore Central Singapore, Singapore, 629110
Owner or operator
Venner Medical (Singapore) Pte Ltd (10029896)
Roles
Specification developer
First device listed
May 13, 2010
Registered through
2026

Devices it lists

DeviceProduct codeClassRoleSource
Cuff, Tracheal Tube, InflatableBSK2Specification developeraccessdata.fda.gov
Tube, Tracheal (W/Wo Connector)BTR2Specification developeraccessdata.fda.gov
Tube, Tracheostomy (W/Wo Connector)BTO2Specification developeraccessdata.fda.gov
Tubing, Pressure And AccessoriesBYX1Specification developeraccessdata.fda.gov

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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
July 28, 2011K110631VENNER TRACHEAL SEAL MONITORBSKSubstantially EquivalentVenner Medical (Singapore) Pte, Ltd.accessdata.fda.gov
July 13, 2010K100950VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBEBTOSubstantially EquivalentVenner Medical (Singapore) Pte, Ltd.accessdata.fda.gov
April 2, 2010K093135VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE AND ENDO TRACHEAL TUBEBTRSubstantially EquivalentVenner Medical (Singapore) Pte, Ltd.accessdata.fda.gov

Compare with other makers

Updated July 28, 2011. 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.