Search FDA 510(k) Devices

5,395 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
769–792 of 174,061
Cleared Dec 23, 2025
ART-Plan+ (v3.1.0)
K253091 · MUJ
Therapanacea Sas
Radiology · 91d
Cleared Dec 23, 2025
Paruu Wearable Breast pump (P16, P16-A, P16-B, P16-C, P16-D, P20, P9, P10,...
K253072 · HGX
Linhejiacheng (Shenzhen) E-Commerce...
Obstetrics & Gynecology · 91d
Cleared Dec 23, 2025
Electric Scooter (S202572J, S2060, M2089, S2050)
K252835 · INI
Guangdong Prestige Technology Co., Ltd.
Physical Medicine · 109d
Cleared Dec 23, 2025
UNITY DX (UDX)
K252633 · OBO
Cylite Pty. , Ltd.
Ophthalmic · 125d
Cleared Dec 23, 2025
NOVEOS Specific IgE (sIgE)
K252493 · DHB
Hycor Biomedical
Immunology · 137d
Cleared Dec 23, 2025
AIR Recon DL
K252379 · LNH
Ge Medical Systems, LLC
Radiology · 146d
Cleared Dec 23, 2025
Aura Glide (FC40)
K252187 · NFO
Aura Medical, LLC
Neurology · 162d
Cleared Dec 23, 2025
Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003...
K252146 · NFO
Shenzhen Siken 3D Technology...
Neurology · 167d
Cleared Dec 23, 2025
GEN5™ and GEN5+™ 3.3mmD Dental Implants
K252145 · DZE
Paragon Implant Mfg., LLC
Dental · 167d
Cleared Dec 23, 2025
SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016)
K251991 · JOJ
Shenzhen Safesecure Medical Infection...
General Hospital · 179d
Cleared Dec 23, 2025
LIAISON NES FLU A/B, RSV & COVID-19
K251978 · QOF
Diasorin Molecular, LLC
Microbiology · 179d
Cleared Dec 23, 2025
VEINOPLUS Back
K251958 · NUH
Dynapulse Medical
Neurology · 181d
Cleared Dec 23, 2025
Healgen® URS Test Strips
K251800 · JMT
Healgen Scientific, LLC
Chemistry · 194d
Cleared Dec 23, 2025
Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV...
K251683 · LPL
Bruno Vision Care, LLC
Ophthalmic · 207d
Cleared Dec 23, 2025
Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)
K251268 · IYN
Edan Instruments, Inc.
Radiology · 243d
Cleared Dec 23, 2025
NizPlant Dental Implant System
K250476 · DZE
Paragon Implant Mfg., LLC
Dental · 307d
Cleared Dec 22, 2025
InnoClip Disposable Clip Applier
K253903 · FZP
Taiwan Surgical Corporation
General & Plastic Surgery · 17d
Cleared Dec 22, 2025
HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)
K253876 · OVE
Globus Medical, Inc.
Orthopedic · 18d
Cleared Dec 22, 2025
InnoClip Clip Applier
K253781 · FZP
Taiwan Surgical Corporation
General & Plastic Surgery · 26d
Cleared Dec 22, 2025
Instylla Delivery Kit
K253769 · FMF
Instylla, Inc.
General Hospital · 27d
Cleared Dec 22, 2025
Syndesmosis TightRope PRO
K253727 · HTN
Arthrex, Inc.
Orthopedic · 28d
Cleared Dec 22, 2025
SKOUT system
K253664 · QNP
Iterative Health
Gastroenterology & Urology · 32d
Cleared Dec 22, 2025
TMINI Miniature Robotic System
K253661 · OLO
THINK Surgical, Inc.
Orthopedic · 32d
Cleared Dec 22, 2025
Theracor
K253339 · KGN
Stimlabs, LLC
General & Plastic Surgery · 83d