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
13393–13416 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 06, 2022
Extended Reservoir
K210714 · LZG
Medtronic Minimed, Inc.
Chemistry · 392d
Cleared Apr 06, 2022
NB 1 SA Implant System
K213506 · DZE
Arum Dentistry Co., Ltd.
Dental · 156d
Cleared Apr 06, 2022
Balloon Dilatation Catheter
K213578 · FDF
Hangzhou AGS MedTech Co., Ltd.
Gastroenterology & Urology · 147d
Cleared Apr 06, 2022
3M Attest Super Rapid Steam Biological Indicator, 3M Attest Super Rapid...
K213809 · FRC
3M Company
General Hospital · 121d
Cleared Apr 06, 2022
Disposable Medical Mask
K214085 · FXX
Hubei Wanli Protective Products Co.,...
General Hospital · 100d
Cleared Apr 06, 2022
Prodigy Thrombectomy System
K214114 · QEW
Truvic Medical, Inc.
Cardiovascular · 97d
Cleared Apr 06, 2022
ALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy System
K220625 · OBP
Remed Co., Ltd.
Neurology · 34d
Cleared Apr 06, 2022
ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire
K220654 · NTE
Cordis Corporation
Cardiovascular · 30d
Cleared Apr 05, 2022
Clever Forehead Thermometer / Clever Medical Forehead Thermometer (Model...
K200946 · FLL
Taidoc Technology Corporation
General Hospital · 727d
Cleared Apr 05, 2022
Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed,...
K212463 · NPL
Geistlich Pharma AG
Dental · 242d
Cleared Apr 05, 2022
DRPx Locking Distal Radius Plate System
K212601 · HRS
Orthopaedic Implant Company
Orthopedic · 231d
Cleared Apr 05, 2022
Infrared Thermometer (model: E201)
K213011 · FLL
Bioland Technology, Ltd.
General Hospital · 197d
Cleared Apr 05, 2022
Medical surgical mask (Black mask, Level 1 and Level 3)
K213450 · FXX
Guangdong Kingfa Sci. & Tech.Co., Ltd.
General Hospital · 161d
Cleared Apr 05, 2022
Verifine Safety Syringe with Fixed Needle
K213560 · FMF
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 147d
Cleared Apr 05, 2022
Digital thermometer, Model DT101, DT102
K213746 · FLL
Guangzhou Berrcom Medical Device Co.,...
General Hospital · 127d
Cleared Apr 05, 2022
Apyx
K213783 · PBQ
Escala Medical
Obstetrics & Gynecology · 123d
Cleared Apr 05, 2022
Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip,...
K213808 · LCX
Co-Innovation Biotech Co., Ltd.
Chemistry · 120d
Cleared Apr 05, 2022
MRCAT Head & Neck
K214081 · MUJ
Philips OY
Radiology · 99d
Cleared Apr 05, 2022
HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound System
K220043 · IYN
Samsung Medison Co., Ltd.
Radiology · 90d
Cleared Apr 05, 2022
Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction...
K220335 · LNH
Canon Medical Systems Corporation
Radiology · 57d
Cleared Apr 05, 2022
Accu-Chek Safe-T-Pro Uno Lancing Device
K220364 · FMK
Roche Diabetes Care, Inc.
General & Plastic Surgery · 56d
Cleared Apr 04, 2022
MediExpand Cervical Expandable VBR System
K212126 · PLR
Cmf Medicon Surgical, Inc.
Orthopedic · 271d
Cleared Apr 04, 2022
EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System
K212624 · QIH
Ever Fortune.Ai, Co., Ltd.
Radiology · 229d
Cleared Apr 04, 2022
ERI Handheld Dental X-ray System (Model AG100)
K213282 · EHD
Energy Resources International Co.,...
Radiology · 185d