Search FDA 510(k) Devices

5,373 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: 2025–2025 ×
3,225 results
25–48 of 3,225
Cleared Dec 23, 2025
TENS&EMS (HZ9151B, HZ9151C, HZ9151D)
K253740 · NUH
Hong Qiangxing (Shenzhen) Electronics...
Neurology · 29d
Cleared Dec 23, 2025
OsteoRemedies Hip Spacer System
K253675 · KWL
Osteoremedies, LLC
Orthopedic · 32d
Cleared Dec 23, 2025
Healgen Accurate Urine Drug Screen Dip Card
K253567 · NGL
Healgen Scientific, LLC
Toxicology · 36d
Cleared Dec 23, 2025
Custom Abutments AS
K253341 · NHA
Medentika GmbH
Dental · 84d
Cleared Dec 23, 2025
OrangeCAD Med Abutments
K253312 · NHA
Orangecad Med GmbH
Dental · 84d
Cleared Dec 23, 2025
UpDoc
K253281 · NDC
Updoc, Inc.
Chemistry · 85d
Cleared Dec 23, 2025
Active-V Total Knee System
K253239 · MBH
Signature Orthopaedics Pty, Ltd.
Orthopedic · 85d
Cleared Dec 23, 2025
MiiS Horus Arthroscope (EJA 100)
K253217 · HRX
Medimaging Integrated Solution, Inc...
Orthopedic · 85d
Cleared Dec 23, 2025
LED Light Therapy Device...
K253135 · OHS
Dongguan Yijiaming Technology Co., Ltd.
General & Plastic Surgery · 89d
Cleared Dec 23, 2025
Sim&Size
K253122 · PZO
Sim&Cure
Neurology · 89d
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