FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: 2026–2026 ×
1,642 results
505–528 of 1,642
Search insights Median review: 137d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared May 12, 2026
CorVision® (91-205-Z0014)
K260051 · MOD
Corvent Medical, Inc.
Anesthesiology · 124d
Cleared May 12, 2026
Senhance Ultrasonic System
K254192 · NAY
Asensus Surgical
General & Plastic Surgery · 140d
Cleared May 12, 2026
Promimic ZrP Surface Dental Implant
K252731 · DZE
Promimic AB
Dental · 257d
Cleared May 11, 2026
PICO SHINING (PICO-K
K261214 · GEX
Speclipse, Inc.
General & Plastic Surgery · 27d
Cleared May 11, 2026
Diagnostic Ultrasound System (MU9)
K260846 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 56d
Cleared May 11, 2026
HardyDisk AST Gepotidacin 10µg (GEP10)
K260842 · JTN
Hardy Diagnostics
Microbiology · 56d
Cleared May 11, 2026
Dual Core
K260805 · EBF
Vericom Co., Ltd.
Dental · 60d
Cleared May 11, 2026
ETHICON™ Circular Stapler (CDH21mm)
K260196 · GDW
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 109d
Cleared May 11, 2026
KARL STORZ Trocars with Valve Seals
K254228 · GCJ
Karl Storz SE & CO. KG
General & Plastic Surgery · 136d
Cleared May 11, 2026
SAYA 86 Radial Access Guide Catheter
K254178 · QJP
Asahi Intecc Co., Ltd.
Neurology · 139d
Cleared May 11, 2026
CFlex Cystoscope - Standard Deflection (0570-0455)
K253696 · FAJ
Verathon Medical (Canada) Ulc
Gastroenterology & Urology · 171d
Cleared May 11, 2026
Velmeni for Dentists (V4D) Endo-Perio
K252953 · MYN
Velmeni, Inc.
Radiology · 237d
Cleared May 11, 2026
Pytheas Your Guided Trajectory
K252880 · OLO
Pytheas Navigation Sas
Orthopedic · 243d
Cleared May 11, 2026
Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO,...
K252655 · DQA
Shenzhen Imdk Medical Technology Co.,...
Anesthesiology · 262d
Cleared May 11, 2026
Protable Phlegm Suction Unit (JMA D01)
K250964 · JCX
Jiangsu Jumao X-Care Medical...
General & Plastic Surgery · 406d
Cleared May 09, 2026
Avanti Distal Elbow ORIF System
K261145 · HRS
Avanti Orthopaedics, LLC
Orthopedic · 32d
Cleared May 09, 2026
aprevo® anterior and lateral lumbar interbody system
K260385 · MAX
Carlsmed, Inc.
Orthopedic · 92d
Cleared May 08, 2026
AerFrame Patient Immobilization System (AFPIS)
K260792 · IYE
Stabilix, LLC
Radiology · 58d
Cleared May 08, 2026
Smylio Aligners
K260788 · NXC
Smylio, Inc.
Dental · 59d
Cleared May 08, 2026
LingOral Dental Design System
K260419 · PNN
Hangzhou ChohoTech Co., Ltd.
Dental · 88d
Cleared May 08, 2026
HipGuide (V 1.0.0.0)
K260321 · LLZ
Orthopedic Driven Imaging, LLC
Radiology · 98d
Cleared May 08, 2026
Arthrex Beaming System
K254215 · HWC
Arthrex, Inc.
Orthopedic · 130d
Cleared May 08, 2026
Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA
K253991 · HSB
Orthofix Srl
Orthopedic · 147d
Cleared May 08, 2026
Hydro Irrigation System
K253679 · GWG
Stryker Instruments
Neurology · 168d