FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
553–576 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 03, 2026
VITA Multi-Function Head Brush (TB-2343F, TB-2442F)
K260179 · NFO
Touchbeauty Beauty & Health...
Neurology · 133d
Cleared Jun 03, 2026
CustoMED Viewer
K260116 · LLZ
CustoMED , Ltd.
Radiology · 140d
Cleared Jun 03, 2026
Roosin Collagen Powder
K254034 · KGN
Roosin Medical Co., Ltd.
General & Plastic Surgery · 169d
Cleared Jun 03, 2026
Roosin Collagen Dressing
K253974 · KGN
Roosin Medical Co., Ltd.
General & Plastic Surgery · 174d
Cleared Jun 03, 2026
Scooter (YD-03)
K253600 · INI
Yurob Rehabilitation Medical Co., Ltd.
Physical Medicine · 197d
Cleared Jun 03, 2026
Upper arm electronic blood pressure monitor (XB-01)
K253124 · DXN
Shenzhen Ziqing Medical Equipment...
Cardiovascular · 251d
Cleared Jun 03, 2026
SIC Abutments including CAD/CAM Solutions
K252904 · NHA
Sic Invent AG
Dental · 265d
Cleared Jun 03, 2026
SteriTite Container System with MediTray Products
K252854 · KCT
Case Medical, Inc.
General Hospital · 268d
Cleared Jun 03, 2026
KARL STORZ Endoscopic Accessories for Urology
K252800 · OCZ
Karl Storz SE & CO. KG
Gastroenterology & Urology · 273d
Cleared Jun 02, 2026
Cube 4D Navigation System, VirtuEye Pro
K261540 · PGW
Fiagon GmbH
Ear, Nose, Throat · 25d
Cleared Jun 02, 2026
DIAFIL
K261093 · EBF
DiaDent Group International
Dental · 61d
Cleared Jun 02, 2026
Pectus Blu System
K261002 · HRS
Biomet Microfixation
Orthopedic · 68d
Cleared Jun 02, 2026
Manual Wheelchair (LW01108)
K260642 · IOR
Anhui Longway Medical Technology Co.,...
Physical Medicine · 95d
Cleared Jun 02, 2026
SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments
K260571 · OLO
Life Spine, Inc.
Orthopedic · 103d
Cleared Jun 02, 2026
DB 4000 High Impact Denture Base
K260569 · EBI
Carbon, Inc.
Dental · 103d
Cleared Jun 02, 2026
Device 300419 Strip
K260364 · MQV
Geistlich Pharma AG
Orthopedic · 118d
Cleared Jun 02, 2026
FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)
K260270 · CAF
FindAir Sp. z o.o.
Anesthesiology · 125d
Cleared Jun 02, 2026
Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St)
K253918 · GEI
F Care Systems USA, LLC
General & Plastic Surgery · 176d
Cleared Jun 02, 2026
MILAN System
K253803 · GEI
Lumenis Be, Ltd.
General & Plastic Surgery · 186d
Cleared Jun 02, 2026
Packaged Assembly, Reusable Navigation Unit
K253507 · ONN
Orthalign, Inc.
Orthopedic · 211d
Cleared Jun 02, 2026
Hemospray Endoscopic Hemostat (HEMO-[X])
K253302 · QAU
Wilson-Cook Medical, Inc.
General & Plastic Surgery · 246d
Cleared Jun 02, 2026
TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems
K253195 · NKG
ZheJiang Decans Medical Devices Co.,...
Orthopedic · 249d
Cleared Jun 02, 2026
Female Culture Device
K252899 · JKA
Zhejiang Kindly Medical Device Co., Ltd.
General Hospital · 264d
Cleared Jun 02, 2026
Tyto Insights for Wheeze Detection (with PCCP)
K252844 · PHZ
Tyto Care , Ltd.
Anesthesiology · 267d