FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
18361–18384 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 18, 2020
Infrared Thermometer
K201980 · FLL
Contec Medical Systems Co.,Ltd
General Hospital · 155d
Cleared Dec 18, 2020
ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf ENT...
K202006 · GEI
ArthroCare Corporation
General & Plastic Surgery · 150d
Cleared Dec 18, 2020
Blue Sky Bio CAD-CAM Abutments
K202026 · NHA
Blue Sky Bio, LLC
Dental · 149d
Cleared Dec 18, 2020
FlowTriever Retrieval/Aspiration System
K202345 · QEW
Inari Medical
Cardiovascular · 122d
Cleared Dec 18, 2020
UltraSlim Digital, UltraSmooth Digital
K202361 · OLI
Ward Photonics, LLC
General & Plastic Surgery · 121d
Cleared Dec 18, 2020
ClearRT Helical kVCT for the Radixact Treatment Delivery System
K202412 · IYE
Accuray Incorporated
Radiology · 116d
Cleared Dec 18, 2020
ADAPT for Gamma3
K202749 · OLO
Stryker GmbH
Orthopedic · 88d
Cleared Dec 18, 2020
IdentiTi Cervical Standalone Interbody System
K202812 · OVE
Alphatec Spine, Inc.
Orthopedic · 85d
Cleared Dec 18, 2020
Invictus™ OCT Spinal Fixation System
K203125 · NKG
Alphatec Spine, Inc.
Orthopedic · 60d
Cleared Dec 18, 2020
S10 Kirra
K203126 · BZD
Resmed Pty , Ltd.
Anesthesiology · 60d
Cleared Dec 18, 2020
Advanix Biliary Stent with NaviFlex RX Delivery System
K203162 · FGE
Boston Scientific Corporation
Gastroenterology & Urology · 56d
Cleared Dec 18, 2020
MOSAIQ Oncology Information System
K203172 · IYE
Elekta Solutions AB
Radiology · 53d
Cleared Dec 18, 2020
Aesculap Caiman 12 Seal and Cut Technology System
K203461 · GEI
Aesculap, Inc.
General & Plastic Surgery · 24d
Cleared Dec 18, 2020
Alphenix, INFX-8000V/B, /S, V9.1
K203551 · OWB
Canon Medical Systems Corporation
Radiology · 14d
Cleared Dec 17, 2020
Aidite PMMA
K190217 · EBG
Aidite (Qinhuangdao) Technology Co.,...
Dental · 682d
Cleared Dec 17, 2020
S dispensing line
K192770 · FMF
Aea Srl
General Hospital · 444d
Cleared Dec 17, 2020
Exofin High Viscosity Topical Skin Adhesive
K200264 · MPN
Chemence Medical, Inc.
General & Plastic Surgery · 318d
Cleared Dec 17, 2020
Single Use Grasping Forceps FG-214P, Single Use Grasping Forceps FG-220P,...
K200342 · EOQ
Olympus Medical Systems Corp.
Ear, Nose, Throat · 310d
Cleared Dec 17, 2020
Wrist Type Blood Pressure Monitor
K200346 · DXN
Avita Corporation
Cardiovascular · 310d
Cleared Dec 17, 2020
pjur WOMAN Nude pjur med SENSITIVE glide
K200730 · NUC
Pjur Group Luxembourg S.A.
Obstetrics & Gynecology · 272d
Cleared Dec 17, 2020
Electric wheelchair (Model: S7012)
K200857 · ITI
Dongguan Prestige Sporting Goods Co.,...
Physical Medicine · 260d
Cleared Dec 17, 2020
AltaTrack equipment, AltaTrack Guidewire, AltaTrack Catheter
K201081 · DQK
Philips Medical System Nederland B.V.
Cardiovascular · 239d
Cleared Dec 17, 2020
In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath
K201165 · LJE
Coloplast Corp.
Gastroenterology & Urology · 230d
Cleared Dec 17, 2020
Primelase Excellence
K201594 · GEX
High Technology Products S.L.U
General & Plastic Surgery · 188d