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
10705–10728 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 06, 2023
BD Vaginal Panel
K223653 · PQA
Becton, Dickinson and Company
Microbiology · 90d
Cleared Mar 06, 2023
A1417MCW/A1717MCW/F1417MCW
K223930 · MQB
H&abyz Co., Ltd.
Radiology · 66d
Cleared Mar 06, 2023
Materialise Shoulder System™ Materialise Shoulder Guide and Models SurgiCase...
K230315 · QHE
Materialise NV
Orthopedic · 28d
Cleared Mar 06, 2023
Savvy Surgical Mask - Level 3
K230383 · FXX
Alg Health, LLC
General Hospital · 21d
Cleared Mar 05, 2023
Nitronox Scavenger Plus
K223452 · CBN
Parker Hannifin Corporation
Anesthesiology · 110d
Cleared Mar 03, 2023
Aspira Pleural Drainage System
K212696 · DWM
Merit Medical Systems, Inc.
Anesthesiology · 555d
Cleared Mar 03, 2023
Dyna Locking Trochanteric Nail™
K221084 · HSB
Innosys
Orthopedic · 324d
Cleared Mar 03, 2023
DHX-70H, XTG-70H
K221587 · EHD
Digimed Co., Ltd.
Radiology · 275d
Cleared Mar 03, 2023
NIKKICART
K221652 · KPO
Renal Care Dialysis Solutions, S.A....
Gastroenterology & Urology · 269d
Cleared Mar 03, 2023
Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)
K221661 · DXC
Compression Works, Inc.
Cardiovascular · 268d
Cleared Mar 03, 2023
INJECTION PIN (KIP(02031-02061) (03031-03061))
K221697 · NDN
Slk Ortho, LLC
Orthopedic · 266d
Cleared Mar 03, 2023
Polypectomy Snare
K221713 · FDI
Hangzhou AGS MedTech Co., Ltd.
Gastroenterology & Urology · 263d
Cleared Mar 03, 2023
Alinity m STI Assay
K222379 · QEP
Abbott Molecular, Inc.
Microbiology · 210d
Cleared Mar 03, 2023
Electronic Sphygmomanometers
K222394 · DXN
Qingdao Yasee Medical Device Co., Ltd.
Cardiovascular · 207d
Cleared Mar 03, 2023
FreeStyle Libre 2 Flash Glucose Monitoring System
K222447 · QBJ
Abbott Diabetes Care, Inc.
Chemistry · 200d
Cleared Mar 03, 2023
imani i2Plus Breast Pump
K222573 · HGX
Imani Co.
Obstetrics & Gynecology · 190d
Cleared Mar 03, 2023
Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i
K222819 · JAK
Canon Medical Systems Corporation
Radiology · 165d
Cleared Mar 03, 2023
Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie)
K222880 · KNT
Endolumik, Inc.
Gastroenterology & Urology · 162d
Cleared Mar 03, 2023
Grappler Suture Anchor R3FLEX IOL System
K223589 · MBI
Paragon 28, Inc.
Orthopedic · 92d
Cleared Mar 03, 2023
PEEK Spinal Infusion Cage
K223776 · MAX
Changzhou Geasure Medical Apparatus...
Orthopedic · 77d
Cleared Mar 03, 2023
EZ Bond Universal
K230009 · KLE
Meta Biomed Co., Ltd.
Dental · 59d
Cleared Mar 03, 2023
Light Based Hair Removal Device GP592
K230060 · OHT
Shenzhen Gsd Tech Co., Ltd.
General & Plastic Surgery · 53d
Cleared Mar 03, 2023
Lyra Influenza A+B Assay
K230236 · OZE
Quidel Corporation
Microbiology · 32d
Cleared Mar 03, 2023
Rebellion, Phantom Multi-Bite Kerrison Rongeur
K230256 · HAE
Morpheus AG
Neurology · 31d