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
14809–14832 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 01, 2022
Vigilant Software Suite – Vigilant Master Med
K210075 · PHC
Fresenius Kabi AG
General Hospital · 413d
Cleared Mar 01, 2022
Digimamo D
K210151 · MUE
Vmi Tecnologias Ltda
Radiology · 404d
Cleared Mar 01, 2022
Dynamyx Digital Pathology Software
K210811 · QKQ
Inspirata, Inc.
Pathology · 349d
Cleared Mar 01, 2022
Sure-Fine Insulin Syringes
K210848 · FMF
Shina Med Corporation
General Hospital · 344d
Cleared Mar 01, 2022
Disposable Sterile Syringe with Safety Needle
K211484 · MEG
Shinva Ande Healthcare Apparatus Co.,...
General Hospital · 293d
Cleared Mar 01, 2022
Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT)
K211776 · FLL
Microlife Intellectual Property GmbH
General Hospital · 265d
Cleared Mar 01, 2022
GoBack Crossing Catheter
K211802 · PDU
Upstream Peripheral Technologies, Ltd.
Cardiovascular · 264d
Cleared Mar 01, 2022
MYAH
K211868 · MXK
Visia Imaging S.R.L.
Ophthalmic · 258d
Cleared Mar 01, 2022
Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOS
K212057 · KRD
Artventive Medical Group, Inc.
Cardiovascular · 243d
Cleared Mar 01, 2022
Restoration® Modular Hip System
K212187 · LPH
Howmedica Osteonics Corp., Dba...
Orthopedic · 231d
Cleared Mar 01, 2022
BoneView
K212365 · QBS
Gleamer
Radiology · 214d
Cleared Mar 01, 2022
Sterile Latex Surgical Gloves Powder Free
K212596 · KGO
Amazing Rubber Products Pvt, Ltd.
General Hospital · 197d
Cleared Mar 01, 2022
Sterile Disposable Temperature Probe
K212945 · FLL
Shenzhen Envisen Industry Co., Ltd.
General Hospital · 167d
Cleared Mar 01, 2022
Wrist-type Fully Automatic Digital Blood Pressure Monitor
K213189 · DXN
Joytech Healthcare Co. , Ltd.
Cardiovascular · 153d
Cleared Mar 01, 2022
Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry,...
K213400 · NUC
Rb Health (Us)
Obstetrics & Gynecology · 134d
Cleared Mar 01, 2022
Blue Topaz Sacroiliac Screw System
K213590 · OUR
Osseus Fusion Systems, LLC
Orthopedic · 109d
Cleared Mar 01, 2022
DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360...
K220109 · MCW
Cardiovascular Systems, Inc.
Cardiovascular · 47d
Cleared Feb 28, 2022
ENFit enteral syringes (NUTRIFIT)
K211661 · PNR
Pentaferte Italia S.R.L.
Gastroenterology & Urology · 272d
Cleared Feb 28, 2022
Disposable Nitrile Examination Gloves
K212833 · LZA
Chifeng Huawei Medical...
General Hospital · 174d
Cleared Feb 28, 2022
Vathin Video Bronchoscope System
K213635 · EOQ
Hunan Vathin Medical Instrument Co.,...
Ear, Nose, Throat · 103d
Cleared Feb 28, 2022
VyLink™ Spinal Screw System
K213750 · NKB
Vy Spine, LLC
Orthopedic · 90d
Cleared Feb 26, 2022
CardioChek Plus Test System
K193406 · NBW
Polymer Technology Systems, Inc....
Chemistry · 810d
Cleared Feb 25, 2022
Masimo SedLine Sedation Monitor and Accessories
K203113 · OLW
Masimo Corporation
Anesthesiology · 498d
Cleared Feb 25, 2022
Cool-tip RF Ablation System E Series
K203150 · GEI
Covidien, LLC
General & Plastic Surgery · 491d