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5,064 devices

The Acumed Wrist Fixation System – 2.4mm Screws (K252356)

Class Class II K252356 HRS
2025-08-21

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 (K252244)

Class Class I K252244 LZA
2025-08-21

LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910) (K251588)

Class Class II K251588 OHS
2025-08-21

MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+ Implant System, MIS Lance+ Conical Connection System (K251647)

Class Class II K251647 DZE
2025-08-21

VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL) (K251579)

Class Class II K251579 LON
2025-08-21

InSee (K241152)

Class Class II K241152 BWF
2025-08-21

EnDrive (EnDriveUS) (K243692)

Class Class I K243692 EKX
2025-08-22

Monoject™ 1mL Tuberculin Syringe Luer-Lock Tip (1180100777); Monoject™ 3mL Syringe, Luer-Lock Tip (1180300777); Monoject™ 6mL Syringe, Luer-Lock Tip (1180600777); Monoject™ 12mL Syringe, Luer-Lock Tip (1181200777); Monoject™ 20mL Syringe, Luer-Lock Tip (1182000777); Monoject™ 35mL Syringe, Luer-Lock Tip (1183500777); Monoject™ 60mL Syringe, Luer-Lock Tip (1186000777); Monoject™ 3mL Syringe, Luer-Lock Tip (8881513934); Monoject™ 6mL Syringe , Luer-Lock Tip (8881516937); Monojec (K243660)

Class Class II K243660 FMF
2025-08-22

CPS Locator 3D Delivery Catheter (K250147)

Class Class II K250147 DQY
2025-08-22

One-Fil Putty Injectable (K251884)

Class Class II K251884 KIF
2025-08-22
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