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Browse 313 FDA-cleared medical devices

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313 devices

PM2 System and ECGuide Connector (K240486)

Class Class II K240486 LJS
2024-09-08

Latex Examination Glove Powder Free (Ocean Blue and Natural White) (K240266)

Class Class I K240266 LYY
2024-09-09

Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with 46 Chemotherapy Drugs, the Opioid Fentanyl citrate, simulated Gastric Acid, Fentanyl in Gastric Acid, the tranquilizer Xylazine, and Xylazine in Fentanyl citrate (Blue) (K241745)

Class Class I K241745 LZA
2024-09-11

3M™ Attest™ Super Rapid Readout Biological Indicator 1492V; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490M (K241710)

Class Class II K241710 FRC
2024-09-12

HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization Wrap, HALYARD® SEQUENTIAL Sterilization Wrap and HALYARD® SMART-FOLD® Sterilization Wrap (K234050)

Class Class II K234050 FRG
2024-09-16

Medline Reusable Sterilization Wrappers (K234132)

Class Class II K234132 FRG
2024-09-17

LOWTEM Crystal 120 (K231893)

Class Class II K231893 MLR
2024-09-18

Perpak™ Sterilization Tyvek Pouch (K241123)

Class Class II K241123 FRG
2024-09-18

Terragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene® Bionova® Self-Contained Biological Indicator (BT96), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40) (K231383)

Class Class II K231383 FRC
2024-09-18

Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer Lock Syringe with Blunt Fill Needle (K241821)

Class Class II K241821 FMF
2024-09-20
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