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Browse 344 FDA-cleared medical devices

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344 devices

Methinks CTA Stroke (K251590)

Class Class II K251590 QAS
2025-08-20

MTS Sulbactam-Durlobactam 0.004/4 – 64/4 µg/mL (SUD) (K251580)

Class Class II K251580 JWY
2025-08-20

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

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

MammoScreen BD (K243685)

Class Class II K243685 QIH
2025-08-22

Maxx Libertas Bipolar Hip Head (Bipolar Hip) (K243634)

Class Class II K243634 KWY
2025-08-25

Motor and Apex Module (MaAM) (K251811)

Class Class I K251811 EBW
2025-08-25

Medical Video Endoscope [Standard Deflection] (URS3005); Medical Video Endoscope [Reverse Deflection] (URS3005E); Medical Video Endoscope [Standard Deflection] (URS3006); Medical Video Endoscope [Reverse Deflection] (URS3006E); Medical Video Endoscope [Standard Deflection] (URS3016); Medical Video Endoscope [Reverse Deflection] (URS3016E); Image processor (DIS8000) (K250049)

Class Class II K250049 FGB
2025-08-26

Medical Gas Analyzer (AG200) (K250148)

Class Class II K250148 CCK
2025-08-28

Millipede70 Aspiration Catheter; Perfuze Aspiration Tube Set (K252392)

Class Class II K252392 NRY
2025-08-29
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