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device 510k
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Avita Corporation — AViTA Arm Type Blood Pressure Monitor Cuff (510k cleared)

September 3, 2025updated 4mo ago
community read0 votes

Product code: DXQ. Advisory committee: Cardiovascular. Type: Traditional

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fda device 510k
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same company · ±60 days · 6

  • device 510kEver Global (Vietnam) Enterprise Corporation — Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, Xylazine, Gastric acid, Fentanyl in Gastric acid and Xylazine in Gastric acid (510k cleared)Aug 21, 2025
  • device 510kO&M Halyard, Inc. — Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric Acid (510k cleared)Aug 18, 2025
  • approvalPOMALIDOMIDE — FDA approvalAug 5, 2025
  • device 510kHartalega NGC Sdn. Bhd. — Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) – Extended Cuff (510k cleared)Jul 30, 2025
  • recallAmerisource Health Services LLC recall (Cls II)Oct 8, 2025
  • approvalMORPHINE SULFATE — FDA approvalOct 9, 2025

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