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Data / Medical devices / United States / NEXT Medical Products Company

NEXT Medical Products Company: FDA-registered device maker in Branchburg, NJ, United States, 2 510(k) clearances

NEXT Medical Products Company is registered with the FDA (registration 2523891) in Branchburg, NJ, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated September 29, 1994. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
2523891
Address
45 Columbia RD, Branchburg, NJ, United States, 08876
Owner or operator
NEXT Medical Products Company (10041610)
Roles
Contract manufacturer, Manufacturer
First device listed
August 13, 2012
Registered through
2026
Brand names listed
Clear Image Singles®, Clear Image Sterile, Clear Image®Ultrasound Gel, Delgado Inflatable Post; Pelvic-Tilt; Shoulder-Float, Goppli Gel, Lithoclear®Gel for Lithotripsy

Devices it lists

DeviceProduct codeClassRoleSource
Cream For X-Ray AttenuationPDK2Contract manufactureraccessdata.fda.gov
Support, Patient PositionCCX1Manufactureraccessdata.fda.gov
System, Imaging, Pulsed Echo, UltrasonicIYO2Contract manufacturer, Manufactureraccessdata.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
September 29, 1994K931909CLEAR IMAGE STERILE DIAGNOSTIC ULTRSOUND GELIYOSubstantially EquivalentSonomed Technology, Inc.accessdata.fda.gov
March 31, 1989K883917NATURAL IMAGE ULTRASOUND TRANSMISSION COUPLANTIYOSubstantially EquivalentSonomed Technology, Inc.accessdata.fda.gov

Compare with other makers

Updated September 29, 1994. 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.