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Data / Medical devices / United States / RyMed Technologies, LLC

RyMed Technologies, LLC: FDA-registered device maker in Austin, TX, United States, 2 510(k) clearances

RyMed Technologies, LLC is registered with the FDA (registration 3005951712) in Austin, TX, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated July 29, 2010. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

FDA registration number
3005951712
Address
6000 W. William Cannon Drive Building B, Suite 300, Austin, TX, United States, 78749
Owner or operator
RyMed Technologies, LLC (10045258)
Roles
Specification developer
First device listed
October 31, 2013
Registered through
2026
Brand names listed
InVision-Plus® CS® with Neutral Advantage? technology IV Connector, InVision-Plus® Junior® with Neutral Advantage? technology IV Connector, InVision-Plus® RED? with Neutral Advantage? technology IV Connector, InVision-Plus® with Neutral Advantage? technology IV Connector

Devices it lists

DeviceProduct codeClassRoleSource
Set, Administration, IntravascularFPA2Specification 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 29, 2010K093489IN VISION-PLUS NANO WITH NEUTRAL ADVANTAGE TECHNOLOGYFPASubstantially EquivalentRymed Technologies, Inc.accessdata.fda.gov
June 24, 1999K991653INVISION-PLUS INJECTION PORT CONNECTOR SYSTEMFPASubstantially EquivalentRymed Technologies, Inc.accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
January 5, 201672997Class IITerminatedInVision-Plus and InVision-Plus Junior Needleless IV Connector, Disposable, Single Use Products are intended for single patient use in intravenous and blood administration sets without the need for needles, thus eliminatPotential for the female luer component of the InVision-Plus IV connector to crack during use.accessdata.fda.gov
May 25, 200636854Not yet classifiedTerminatedRYM-5000 InVision-Plus Neutral Displacement I.V. Connector, packaged 200 units per box, 5 boxes per case (1000 units/case); labeled as Sterile-Nonpyrogenic; assembled in Mexico for Rymed Technologies, Inc., Austin, TX.Weld failures on IV connector (area of female luer and spike body)accessdata.fda.gov

Compare with other makers

Updated January 21, 2016. 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.