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Browse 5,064 FDA-cleared medical devices

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5,064 devices

Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator) (K252412)

Class Class II K252412 GEI
2025-10-31

Kii Structural Balloon Access System (K252442)

Class Class II K252442 GCJ
2025-10-31

Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15)) (K252160)

Class Class II K252160 OMB
2025-10-31

Diode Laser Hair Removal Machine (GLD01) (K252427)

Class Class II K252427 GEX
2025-10-31

Freedom Metaphyseal Cone Implants (Metaphyseal Cones) (K252777)

Class Class II K252777 MBH
2025-10-31

Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System (K252074)

Class Class II K252074 IYN
2025-10-31

GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100 (K251041)

Class Class II K251041 FDS
2025-10-31

Flexible Ureterorenoscope system (Electronic Endoscope Image Processor, model: SP-TXCLQ12.1, Flexible Ureterorenoscope, model: SP-SNGSYJ 2.0, SP-SNGSYJ 2.2, SP-SNGSYJ 2.5, SP-SNGSYJ 2.8) (K250917)

Class Class II K250917 FGB
2025-10-31

Pulsenmore ES (DEN240074)

Class Class II DEN240074 SGJ
2025-10-31

Hydro Print Premium Fast Set – 454g (1lb) (052037); Hydro Print Premium Regular Set – 454g (1lb) (052327); Chroma Print Premium Fast Set – 454g (1lb) (052457); Chroma Print Premium Regular Set – 454g (1lb) (051460); Perfil Pro – 454g (1lb) (056213); Perfil Pro+ – 454g (1lb) (056121); Perfil Pro Chroma – 454g (1lb) (056122); Hydro Print Premium Fast Set – Multi Pack (056205); Hydro Print Premium Regular Set – Multi Pack (056208); Hydro Print Premium Fast Set – 9,07Kg (20lb) (056204); (K253501)

Class Class II K253501 ELW
2025-10-31
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