FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Multiple Violations at ELITech Netherlands Facility

[ Price : $8.95]

FDA warns ELITech Group about QS and MDR violations at its manufacturing facility in The Netherlands.

Mass Spectrometer for Microorganism Detection into Class 2

[ Price : $8.95]

Federal Register notice: FDA classifies the mass spectrometer system for clinical use for identifying microorganisms into Class II...

QS Violations at Germanys DRG Instruments

[ Price : $8.95]

FDA warns Germanys DRG Instruments about QS and MDR violations in its manufacturing of several ELISA devices.

Class 2 for Non-microbial Analyte Detectors for Sepsis

[ Price : $8.95]

Federal Register notice: FDA classifies as Class 2 devices that detect and measure non-microbial analytes in human clinical specim...

54 ANDAs Withdrawn by Watson and Barr Labs

[ Price : $8.95]

Federal Register notice: FDA withdraws the marketing of 54 ANDAs requested by Watson Laboratories and Barr Laboratories.

Latest FDA Warning Letters

[ Price : $8.95]

FDA releases its latest batch of Warning Letters that includes DRG Instruments, ELITech Group SAS, Pelvic Therapies, Sohail M. Kha...

FDA Steps to Promote Medical Device Innovation and Access

[ Price : $8.95]

FDA commissioner Scott Gottlieb outlines agency steps to promote medical device innovation, including one draft and two finalized ...

FDA Clears Ortek Dental Cavity Detector

[ Price : $8.95]

FDA clears an Ortek Therapeutics 510(k) for the Ortek ECD, a lightweight tabletop device designed as an aid for dental professiona...

FDA Supports WHO Drug Dictionary

[ Price : $8.95]

Federal Register notice: FDA announces support for the most current B3-format annual version of the World Health Organization Drug...

FDA Debars Nguyen over Misdemeanor Conviction

[ Price : $8.95]

Federal Register notice: FDA denies a request for a hearing and issues an order debarring Trang Doan Nguyen for five years from pr...