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Wavelength

National Therapy Products Inc · Model NTPF900X · UDI-DI 00628108100240

MUI

510(k) clearances

Adverse events

Recalls

Facilities

Description

Wavelength HV Transmission Gel 210L

Recalls

Date	Firm	Reason
2023-07-07	Advance Medical Designs, Inc.	Ultrasound gel mislabeled with inappropriate use.
2023-07-07	Advance Medical Designs, Inc.	Ultrasound gel mislabeled with inappropriate use.
2023-06-09	Turkuaz Saglik Hizmetleri Medikal Temizlik Kim. Ur. San. ve Tic. A.S.	Sterility of Ultrasound gel can not be guaranteed.
2020-08-13	Pharmaceutical Innovations, Inc.	The firm registered the product as a Class I device, but has since been informed by FDA that the device is not Class I and requires a 510(k) submission.
2012-03-02	Pharmaceutical Innovations, Inc.	Other-Sonic GENERIC ULTRASOUND TRANSMISSION GEL is being recalled due to possible microbial contamination. An FDA Safety Communication was issued for this product on April 18, 2012
2012-03-02	Pharmaceutical Innovations, Inc.	Other-Sonic GENERIC ULTRASOUND TRANSMISSION GEL is being recalled due to possible microbial contamination. An FDA Safety Communication was issued for this product on April 18, 2012

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.