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
20065–20088 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 14, 2020
Distal Humerus Plating System
K200367 · HRS
Skeletal Dynamics, Inc.
Orthopedic · 90d
Cleared May 14, 2020
Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal...
K200700 · LIT
Creagh Medical, Ltd.
Cardiovascular · 58d
Cleared May 14, 2020
Skeletal Dynamics Midshaft Humerus Plating System
K200701 · HRS
Skeletal Dynamics, Inc.
Orthopedic · 57d
Cleared May 14, 2020
Reliance Endoscope Processing System
K200989 · NZA
STERIS Corporation
General Hospital · 29d
Cleared May 14, 2020
Lumipulse G CA19-9-N
K200997 · NIG
Fujirebio Diagnostics,Inc.
Immunology · 28d
Cleared May 14, 2020
Syngo.CT CaScoring
K201034 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 24d
Cleared May 14, 2020
PercuNav Image Fusion and Interventional Navigation
K201053 · JAK
Philips Ultrasound, Inc.
Radiology · 23d
Cleared May 13, 2020
Dr-Ho's Foot Pad Electrode (Models: DHFRE-I, CP-I, CP-II, CP-III)
K190118 · GXY
Guangzhou Xinbo Electronic Co., Ltd.
Neurology · 475d
Cleared May 13, 2020
308nm Excimer System
K192642 · FTC
Chongqing Peninsula Medical...
General & Plastic Surgery · 232d
Cleared May 13, 2020
Purzir Dental Zirconia
K193055 · EIH
3DBiocad
Dental · 194d
Cleared May 13, 2020
InCore MPJ System
K200124 · HWC
Nextremity Solutions, Inc.
Orthopedic · 113d
Cleared May 13, 2020
Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled
K200205 · NLH
Stryker Sustainability Solutions
Cardiovascular · 106d
Cleared May 13, 2020
Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite,...
K200782 · MBH
Howmedica Osteonics Corp.
Orthopedic · 48d
Cleared May 13, 2020
EVOL Spinal Interbody System
K200991 · MAX
Cutting Edge Spine, LLC
Orthopedic · 28d
Cleared May 13, 2020
Medtronic Model 5392 External Pulse Generator (EPG)
K201011 · DTE
Medtronic, Inc.
Cardiovascular · 26d
Cleared May 12, 2020
EZ-Inject Single use Needle
K192222 · FMI
Poonglim Pharmatech, Inc.
General Hospital · 270d
Cleared May 12, 2020
HealthVCF
K192901 · QFM
Zebra Medical Vision, Ltd.
Radiology · 210d
Cleared May 12, 2020
Dymaxeon Spine System
K192930 · NKB
Back 2 Basics Direct, LLC
Orthopedic · 208d
Cleared May 12, 2020
AUDERE Lumbar Spacer System
K193457 · MAX
Met One Technologies
Orthopedic · 148d
Cleared May 12, 2020
Disposable ECG Cable
K200026 · DSA
Shenzhen Changke Connect Electronics...
Cardiovascular · 127d
Cleared May 12, 2020
Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W)
K201043 · MQB
Iray Technology Taicang , Ltd.
Radiology · 22d
Cleared May 12, 2020
Cure™ Lumbar Plate System
K201136 · KWQ
Meditech Spine, LLC
Orthopedic · 14d
Cleared May 11, 2020
Thunderbeat Open Fine Jaw Type X Hand Instrument
K192103 · GEI
Olympus Medical Systems Corp.
Ear, Nose, Throat · 280d
Cleared May 11, 2020
Arcad SmileStudio and Aligner System
K192244 · NXC
Arcadlab
Dental · 266d