FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
13105–13128 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 01, 2022
NovaCore Semi-Automatic Biopsy Instrument
K213232 · KNW
Argon Medical Devices
General & Plastic Surgery · 274d
Cleared Jul 01, 2022
CROSSLEAD Peripheral Guide Wire
K213315 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 270d
Cleared Jul 01, 2022
GEM
K213385 · KRD
Obsidio, Inc.
Cardiovascular · 261d
Cleared Jul 01, 2022
Bladder Scanner, Model Name:M5
K213488 · IYO
Suzhou Peaksonic Medical Technology...
Radiology · 242d
Cleared Jul 01, 2022
Nihon Kohden NKV-330 Ventilator System
K213521 · MNT
Nihon Kohden Orangemed, Inc.
Anesthesiology · 240d
Cleared Jul 01, 2022
Ennovate Cervical Spinal and Occiput System
K213871 · NKG
Aesculap Implant Systems, LLC
Orthopedic · 200d
Cleared Jul 01, 2022
ENT Nasopharyngoscope and Accessories
K214050 · EOB
Medimaging Integrated Solution, Inc...
Ear, Nose, Throat · 186d
Cleared Jul 01, 2022
NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter
K220171 · QTF
Northeast Scientific, Inc.
Cardiovascular · 161d
Cleared Jul 01, 2022
Home use hair removal device
K220248 · OHT
Shenzhen Mareal Tech Co., Ltd.
General & Plastic Surgery · 151d
Cleared Jul 01, 2022
CerroZone Mobile
K220298 · FRF
Cerrozone
General Hospital · 149d
Cleared Jul 01, 2022
PuraPly Micronized Wound Matrix (PuraPly MZ)
K220317 · KGN
Organogenesis, Inc.
General & Plastic Surgery · 148d
Cleared Jul 01, 2022
Ergoline Vitality Total Light 3, Planet Fitness 50/4 TLT by Ergoline, Planet...
K220500 · LEJ
Jk Holding GmbH
General & Plastic Surgery · 129d
Cleared Jul 01, 2022
Prevena Restor Adapti-Form Dressing
K220660 · OMP
3M Healthcare Business Group
General & Plastic Surgery · 116d
Cleared Jul 01, 2022
AcQMap High Resolution Imaging and Mapping System
K220784 · DQK
Acutus Medical, Inc.
Cardiovascular · 106d
Cleared Jul 01, 2022
i_ Field 1.5T Superconducting Magnetic Resonance Imaging System
K221025 · LNH
Mri Division,Beijing Wandong Medical...
Radiology · 86d
Cleared Jul 01, 2022
Power Wheelchair
K221026 · ITI
Zhejiang Innuovo Rehabilitation...
Physical Medicine · 86d
Cleared Jul 01, 2022
Astroglide Warming
K221036 · NUC
Biofilm, Inc.
Obstetrics & Gynecology · 85d
Cleared Jul 01, 2022
Insulin Pen Needle
K221176 · FMI
Tianjin Huahong Technology Co., Ltd.
General Hospital · 67d
Cleared Jul 01, 2022
Footmotion Plating System
K221395 · HRS
Newclip Technics
Orthopedic · 49d
Cleared Jul 01, 2022
2-Way 100% Silicone ClearTract Catheter
K221625 · EZL
Silq Technologies Corporation
Gastroenterology & Urology · 25d
Cleared Jul 01, 2022
J-Temp
K221909 · EBF
Ultradent Products, Inc.
Dental · 1d
Cleared Jun 30, 2022
Cholesterol2
K203597 · CHH
Abbott Ireland Diagnostics Division
Chemistry · 568d
Cleared Jun 30, 2022
hCG One Step Pregnancy Test
K212418 · LCX
Healstone Biotech, Inc.
Chemistry · 331d
Cleared Jun 30, 2022
Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue...
K212785 · DZE
Blue Sky Bio, LLC
Dental · 302d