SEATTLE--(BUSINESS WIRE)--Tasso, Inc., the leading provider of convenient, clinical-grade blood collection solutions, today announced that the U.S. Food and Drug Administration (FDA) has cleared its ...
Vestagen Protective Technologies, a developer of healthcare worker uniforms and scrubs, received FDA clearance as a Class II medical device for its Vestex apparel — the first daily-wear scrubs to ...
Opternative, a Chicago-based purveyor of online and mobile refractive eye exams, received a warning letter from the FDA last fall. The October 30 warning letter was only recently made public by the ...
AUSTIN, Texas, Feb. 8, 2023 /PRNewswire/ -- Recens, Inc. dba CoolHealth ("CoolHealth"), a venture-backed medical device company developing innovative cooling technologies, is entering the U.S. market ...
SAN FRANCISCO, Oct. 30, 2025 /PRNewswire/ -- Sirona Medical today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Sirona Advanced Imaging Suite, marking ...
Starting in September, class II medical devices will be required to be equipped with a unique device identifier to be in compliance with UDI regulations. The U.S. Food and Drug Administration passed ...
The U.S. Food and Drug Administration should replace its 35-year-old 510(k) clearance process for medical devices, says a new report issued by the Institute of Medicine. “The committee found that the ...
Sun Pharmaceutical Industries has launched a nationwide recall of ADHD medication pills after laboratory tests revealed the capsules failed to dissolve properly, raising concerns for thousands of ...
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