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: Cleared only ×
174,955 results
7513–7536 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 26, 2024
Stone Extraction Balloon...
K232752 · GCA
Jiangsu Vedkang Medical Science and...
Gastroenterology & Urology · 171d
Cleared Feb 26, 2024
VADER® Pedicle System
K232628 · NKB
Icotec AG
Orthopedic · 181d
Cleared Feb 26, 2024
Stellaris Elite vision enhancement system
K232084 · HQC
Bausch and Lomb
Ophthalmic · 228d
Cleared Feb 26, 2024
GOLFF Sterile Anti-Fog Solution
K231822 · OCT
Batrik Medical Manufacturing, Inc.
Gastroenterology & Urology · 250d
Cleared Feb 26, 2024
TENS device-HeadaTerm 2 (Model: YF-HT2)
K230782 · PCC
Wat Medical Technology, Inc.
Neurology · 341d
Cleared Feb 26, 2024
BIS™ Advance Monitoring System
K230693 · OLW
Covidien, LLC
Anesthesiology · 350d
Cleared Feb 23, 2024
Iconix Knotless Anchor
K240213 · MBI
Riverpoint Medical
Orthopedic · 29d
Cleared Feb 23, 2024
COGNiTiON™ Staple System
K240212 · JDR
Ortho Solutions UK , Ltd.
Orthopedic · 29d
Cleared Feb 23, 2024
PathLoc SI Joint Fusion System
K240201 · OUR
L & K Biomed Co., Ltd.
Orthopedic · 29d
Cleared Feb 23, 2024
MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface,...
K240190 · DTR
Medtronic
Cardiovascular · 30d
Cleared Feb 23, 2024
Lymphedema Compression
K240011 · JOW
Jkh Health Co., Ltd.
Cardiovascular · 52d
Cleared Feb 23, 2024
Ivotion Base Print
K233995 · EBI
Ivoclar Vivadent, Inc.
Dental · 67d
Cleared Feb 23, 2024
ENSO (Model 2)
K233784 · NUH
Hinge Health, Inc.
Neurology · 88d
Cleared Feb 23, 2024
AIO Breathe
K233754 · LQZ
Aiomega, LLC
Dental · 93d
Cleared Feb 23, 2024
RADspeed Pro
K233722 · KPR
Shimadzu Corporation
Radiology · 94d
Cleared Feb 23, 2024
Exceed Unlimited
K233709 · QAI
Mt. Derm GmbH
General & Plastic Surgery · 95d
Cleared Feb 23, 2024
Overjet Charting Assist
K233590 · QIH
Overjet, Inc.
Radiology · 107d
Cleared Feb 23, 2024
Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504,...
K233576 · KPI
Shenzhen Konmed Technology Co., Ltd.
Gastroenterology & Urology · 108d
Cleared Feb 23, 2024
Navigation Tracking Instruments
K232800 · OLO
SI-BONE, Inc.
Orthopedic · 164d
Cleared Feb 23, 2024
Soldier Microcatheter
K232536 · DQO
Embolx, Inc.
Cardiovascular · 186d
Cleared Feb 23, 2024
Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature...
K232228 · DJG
Shanghai Accurature Diagnostics Co.,...
Toxicology · 211d
Cleared Feb 23, 2024
rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono
K232174 · EIH
Genoss Co., Ltd.
Dental · 217d
Cleared Feb 23, 2024
StatStrip Glucose Hospital Meter System
K232075 · PZI
Nova Biomedical Corporation
Chemistry · 226d
Cleared Feb 23, 2024
CONTOUR® PLUS BLUE Blood Glucose Monitoring System
K231679 · NBW
Ascensia Diabetes Care
Chemistry · 259d