FDA releases its latest batch of Warning Letters that include Integra LifeSciences, Mentor Worldwide and Acclarent, Nutra Pharma, Sientra, and United ...
Stokes Healthcare recalls one lot of veterinary-use pilocarpine 0.1% ophthalmic solution because it has been found to contain a higher level of the pr...
FDA clears a Via Surgical 510(k) for the FasTouch Absorbable Fixation System, which features automated lockable surgical mesh fixation.
FDA accepts for review an Aimmune Therapeutics BLA for AR101 as a treatment to reduce the risk of anaphylaxis following accidental exposure to peanuts...
FDA clears an Intuitive 510(k) for the da Vinci SP robotic surgical system for use in certain transoral otolaryngology procedures in adults.
An opinion piece by former FDA associate commissioner Wayne Pines predicts that most initiatives undertaken by commissioner Scott Gottlieb will contin...
Cook Medical recalls one lot of the Transseptal Needle due to a manufacturing error that resulted in some needle tips missing the back bevel that crea...
Hospira recalls three lots of sodium bicarbonate injection USP, 50 mEq/50 mL (1 mEq/mL) due to the presence of particulate matter, which has been conf...