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FDA clears an OssDsign 510(k) to market its Cranial PSI Accessories, which are a set of 3D-printed, patient-specific accessory dev...[ Price : $8.95]
A public interest group says FDA has missed a self-imposed six-month deadline to assess levels of the carcinogen nitrosamine that ...[ Price : $8.95]
FDA clears a Wontech 510(k) for its low level laser therapy hair loss treatment device, HairBoom Air.[ Price : $8.95]
Federal Register notice: FDA announces its Web site address where CDRH will post two lists of guidance documents that the Center i...[ Price : $8.95]
Federal Register notice: FDA submits to OMB an information collection extension for 510(k) Third-Party Review Program.[ Price : $8.95]
Innoveix Pharmaceuticals recalls all sterile compounded drug products due to sterility assurance concerns.[ Price : $8.95]
Federal Register notice: FDA sends to OMB an information collection extension for a guidance on cvms electronic submission system....[ Price : $8.95]
FDA issues a highly redacted 38-page Form-483 following a recent inspection at drug manufacturer Cipla in Goa, India.