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Browse 517 FDA-cleared medical devices

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517 devices

SpineAR SNAP (SyncAR Spine) (K252054)

Class Class II K252054 SBF
2025-09-29

SMART PCFD (K250023)

Class Class II K250023 QIH
2025-09-29

Shear Wave Quantificational Ultrasound Diagnostic System (FH9000/FH7000/FH6000/FH5000/FH3000/FH1000) (K250026)

Class Class II K250026 IYN
2025-10-01

Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (name not finalized) Sleeved IC 3 Plus (name not finalized) Sleeved IC 3 Plus Pocket (name not finalized) (N/A) (K251468)

Class Class II K251468 EZD
2025-10-03

Shiley™ Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley™ Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley™ Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley™ Oral RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (115-XXOR) Shiley™ Nasal RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (119-XXNR) (K250173)

Class Class II K250173 BTR
2025-10-06

Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens (K250364)

Class Class II K250364 LPL
2025-10-07

SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002) (K250645)

Class Class II K250645 FER
2025-10-09

Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U) (K250351)

Class Class II K250351 KNS
2025-10-10

SoClean 3+ (K243815)

Class Class II K243815 QXQ
2025-10-10

syngo.CT Dual Energy (K251805)

Class Class II K251805 JAK
2025-10-15
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