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FDA warns Japans Nidek Co. about Quality System violations in its manufacturing of non-sterile laser devices.[ Price : $8.95]
Boston Scientific says a clinical trial of its OffRoad Re-entry catheter system performed better than pre-specified trial goals.[ Price : $8.95]
FDA says it is working with CDC and the Hawaii Health Department to investigate cases of acute non-viral hepatitis in Hawaii that ...[ Price : $8.95]
In its latest batch of Warning Letters, FDA cites Anji Zheng Bang Medical Instruments, Batrik Medical Mfg., and Nidek Co.[ Price : $8.95]
Ventripoint Diagnostics files FDA-requested clinical data to support an earlier 510(k) for the Ventripoint Medical System for use ...[ Price : $8.95]
A Washington Post article examines increased scrutiny by FDA of contract testing labs because they have played a large role in all...[ Price : $8.95]
Atossa Genetics recalls its ForeCYTE Breast Health Test and the Mammary Aspiration Specimen Cytology Test device from the market.[ Price : $8.95]
FDA clears a Binder Biomedical 510(k) for its Logic System, a stand-alone intervertebral body fusion device.