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
13705–13728 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 02, 2022
Medline UNITE Calcaneal Fracture Plating System
K213567 · HRS
Medline Industries, LP
Orthopedic · 113d
Cleared Mar 02, 2022
Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph
K213579 · OAS
Fona S.R.L
Radiology · 112d
Cleared Mar 02, 2022
A-dec 300, A-dec 500
K213932 · EIA
A-Dec, Inc.
Dental · 76d
Cleared Mar 02, 2022
Dental Image Plate Scanner, Model DFC-4T-SMART
K214091 · MUH
Hefei Dentafilm Medical Equipment...
Radiology · 64d
Cleared Mar 02, 2022
angioLOCK Polymer Ligating Clip
K220006 · FZP
A2 Medical Systems, LLC
General & Plastic Surgery · 57d
Cleared Mar 01, 2022
LOTA SLA Dental Implant System and LOTA HA Dental Implant System
K202046 · DZE
Kj Meditech Co., Ltd.
Dental · 586d
Cleared Mar 01, 2022
Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines...
K210073 · FRN
Fresenius Kabi AG
General Hospital · 413d
Cleared Mar 01, 2022
Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link,...
K210074 · FRN
Fresenius Kabi AG
General Hospital · 413d
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