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The FDA sent devicemaker Vapotherm a June 12 warning letter for serious good manufacturing practices (GMP) and quality system regulation (QSR) deviations.
BIOLASE Technology, Inc., a medical technology company that develops, manufactures and markets lasers and related products focused on technologies for improved applications and procedures in dentistry and medicine, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) allowing it to market its OCULASE MD(TM) Laser System for general ophthalmic soft tissue surgical indications.
Tissue Technologies LLC, which makes bandages for non-healing wounds, had its first product approved by the U.S. Food and Drug Administration this month.
The Food and Drug Administration (FDA) is denying the petitions submitted by IM Systems to reclassify the SleepCheck, the ActiTrac, and PAM-RL devices from class II (special controls) to class I (general controls).
Disetronic Medical Systems, based in Fishers, Ind., July 13 announced a voluntary nationwide recall of its D-TRONplus power packs for D-TRONplus insulin pumps.