Device Directory

Browse 313 FDA-cleared medical devices

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313 devices

Profoject™ Disposable Syringe, Profoject™ Disposable Syringe with Needle (K252033)

Class Class II K252033 FMF
2025-07-25

SIGMA Spectrum Infusion Pump with Master Drug Library (K251640)

Class Class II K251640 FRN
2025-07-28

Spectrum IQ Infusion System with Dose IQ Safety Software (3570009) (K251636)

Class Class II K251636 FRN
2025-07-28

BD Plastipak™ Syringe (K251350)

Class Class II K251350 FMF
2025-07-29

TSK Syringe (K250127)

Class Class II K250127 QNQ
2025-07-30

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 (K251319)

Class Class I K251319 LZA
2025-07-30

Intraosseous Infusion Needles (K250724)

Class Class II K250724 FMI
2025-07-30

HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire – Basic Kit (70001301); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire – Basic Kit (70001302); HydroPICC 4Fr Single Lumen Marked catheter – Maximal Barrier kit (70001304); HydroPICC 5Fr Dual Lumen Marked catheter, 130 cm guidewire – Basic Kit (70002301); HydroPICC 5Fr Dual Lumen Marked catheter, 70 cm guidewire – Basic Kit (70002302); HydroPICC 5Fr Dual Lumen Marked catheter – Maximal Barrier kit (70002304); Hydr (K243458)

Class Class II K243458 LJS
2025-08-01

Sparta Infusion Set for Insulin (K243841)

Class Class II K243841 FPA
2025-08-01

eZSURE™ Empty Fluid Container (K252094)

Class Class II K252094 KPE
2025-08-01
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