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FDA hits Renovo with warning letter over reprocessed medical devices
MedTech Dive via Yahoo Finance· 3 months agoDive Brief: Renovo received a warning letter in October for supplying reprocessed medical devices...
Cardinal Health recalls procedure kits over plastic syringes made in China
MedTech Dive via Yahoo Finance· 9 hours agoDive Brief: Cardinal Health has recalled procedure kits that contain plastic syringes made by...
FDA warning letter accuses Wavi of selling unapproved neurological device
MedTech Dive via Yahoo Finance· 8 months agoDive Brief: The Food and Drug Administration has sent a warning letter to Wavi, accusing the company...
Philips failed to report corrections of CT machines, FDA says in warning letter
MedTech Dive via Yahoo Finance· 2 months agoDive Brief: The Food and Drug Administration identified problems with a Royal Philips facility that...
FDA warns Soulaire to stop selling device outside authorized uses
MedTech Dive via Yahoo Finance· 2 months agoSoulaire marketed its external counterpulsation system to grow new arteries, repair organ...
Philips (PHG) Receives FDA Warning Letter Regarding CT Systems
Zacks via Yahoo Finance· 2 months agoKoninklijke Philips PHG recently received a warning letter from the FDA that outlines issues...
US FDA sends warning letter to Cardinal Health for marketing unapproved devices
Reuters via Yahoo News· 2 months agoThe U.S. Food and Drug Administration in 2023 recommended against the use of some China-made...
FDA warns Japan's Olympus units over testing violations
Reuters via Yahoo News· 1 year agoWarning letters pertain to a category of devices known as endoscopes, which allow doctors to see and...
FDA looks into dental device after KHN-CBS News investigation of patient harm
CBS News via Yahoo News· 1 year agoLawsuits allege grievous harm to patients' teeth. The FDA's interest in the AGGA dental device...
Cardinal receives FDA warning letter over unapproved syringes
MedTech Dive via Yahoo Finance· 2 months agoThe agency has recently increased scrutiny of plastic syringes made in China because of safety...
