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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
13513–13536 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 24, 2022
Mobility Scooter, Model W3468
K220207 · INI
Zhejiang Innuovo Rehabilitation...
Physical Medicine · 58d
Cleared Mar 24, 2022
Disposable Medical Synthetic Nitrile Examination Gloves
K220354 · LZA
Niujian Technology Co., Ltd.
General Hospital · 44d
Cleared Mar 24, 2022
FlareHawk Interbody Fusion System
K220453 · MAX
Integrity Implants, Inc.
Orthopedic · 35d
Cleared Mar 24, 2022
Erchonia Zerona Z-Bed
K220519 · OLI
Erchonia Corporation
General & Plastic Surgery · 29d
Cleared Mar 24, 2022
Emerge Monorail PTCA Dilatation Catheter
K220629 · LOX
Boston Scientific
Cardiovascular · 20d
Cleared Mar 24, 2022
X-Pac Expandable Lumbar Cage System
K220655 · MAX
Expanding Innovations, Inc.
Orthopedic · 17d
Cleared Mar 23, 2022
LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial...
K210718 · FRO
Huizhou Foryou Medical Devices Co., Ltd.
General & Plastic Surgery · 378d
Cleared Mar 23, 2022
PathBuilder Transseptal Needle
K212625 · DRC
Shanghai Microport EP Medtech Co., Ltd.
Cardiovascular · 217d
Cleared Mar 23, 2022
PathBuilder Transseptal Guiding Introducer
K212626 · DYB
Shanghai Microport EP Medtech Co., Ltd.
Cardiovascular · 217d
Cleared Mar 23, 2022
Disposable Medical Surgical Mask
K212726 · FXX
Hubei Huaqiang High-Tech Co., Ltd.
General Hospital · 208d
Cleared Mar 23, 2022
DRX-Rise Mobile X-ray System
K213568 · IZL
Carestream Health
Radiology · 134d
Cleared Mar 23, 2022
Iridex 810 Laser
K213592 · HQF
Iridex Corporation
Ophthalmic · 131d
Cleared Mar 23, 2022
BD Surgiphor Antimicrobial Irrigation System
K213616 · FQH
Becton, Dickinson and Company
General & Plastic Surgery · 128d
Cleared Mar 23, 2022
ArthroFree Wireless Surgical Camera System
K213860 · GCJ
Lazurite Holdings, LLC
General & Plastic Surgery · 103d
Cleared Mar 23, 2022
Project E Beauty LED Light Therapy Mask (Model: PE730)
K214101 · OHS
Duplex International Trading Limited
General & Plastic Surgery · 84d
Cleared Mar 23, 2022
Total Immunoglobulin E (IgE)
K220178 · DGC
Beckman Coulter, Inc.
Immunology · 61d
Cleared Mar 23, 2022
COPAL exchange G hip spacer
K220492 · KWY
Heraeus Medical GmbH
Orthopedic · 29d
Cleared Mar 23, 2022
Pounce Thrombectomy System
K220501 · QEW
Surmodics,Inc.
Cardiovascular · 29d
Cleared Mar 22, 2022
Athelas Home
K200828 · GKZ
Athelas, Inc.
Hematology · 722d
Cleared Mar 22, 2022
Creatinine2
K210452 · CGX
Abbott Ireland Diagnostics Division
Chemistry · 399d
Cleared Mar 22, 2022
PLEXR PLUS
K210693 · GEI
Gmv S.R.L.
General & Plastic Surgery · 379d
Cleared Mar 22, 2022
Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5
K212960 · IYN
Canon Medical Systems Corporation
Radiology · 187d
Cleared Mar 22, 2022
AMSafe Pre-Filled Normal Saline Flush Syringe
K213522 · NGT
Amsino International, Inc.
General Hospital · 139d
Cleared Mar 22, 2022
Powder Free Blue Nitrile Examination Gloves
K213678 · LZA
Lienteh Technology Sdn Bhd
General Hospital · 120d