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
20857–20880 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 13, 2020
ClearPoint System and Accessories
K200079 · HAW
Mri Interventions, Inc.
Neurology · 30d
Cleared Feb 12, 2020
Leltek Ultrasound Imaging System
K191235 · IYN
Leltek, Inc.
Radiology · 280d
Cleared Feb 12, 2020
Biograph Horizon
K193178 · KPS
Siemens Medical Solution USA, Inc.
Radiology · 86d
Cleared Feb 11, 2020
CAPENERGY - C100, C200, C300, C400, C50
K191202 · PBX
Capenergy Medical S.L.
General & Plastic Surgery · 281d
Cleared Feb 11, 2020
Cervitec F
K191453 · LBH
Ivoclar Vivadent, AG
Dental · 256d
Cleared Feb 11, 2020
Acteon Imaging Suite
K192165 · LLZ
De Gotzen S.R.L.
Radiology · 186d
Cleared Feb 11, 2020
ULab Systems Dental Aligner Kit
K192596 · NXC
Ulab Systems, Inc.
Dental · 144d
Cleared Feb 11, 2020
AcQMap High Resolution Imaging and Mapping System
K193013 · DQK
Acutus Medical, Inc.
Cardiovascular · 105d
Cleared Feb 11, 2020
EzRay Air Portable (Model: VEX-P300)
K200182 · EHD
VATECH Co., Ltd.
Radiology · 18d
Cleared Feb 10, 2020
K3Pro Konus New Abutments and Implants
K190192 · DZE
Argon Med. Productions Vertriebs...
Dental · 371d
Cleared Feb 10, 2020
Elos Accurate Hybrid Base
K191919 · NHA
Elos Medtech Pinol A/S
Dental · 207d
Cleared Feb 10, 2020
JO for Him H2O Gel Original Personal Lubricant
K192203 · NUC
United Consortium
Obstetrics & Gynecology · 180d
Cleared Feb 10, 2020
Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy...
K192377 · IYE
Varian Medical Systems, Inc.
Radiology · 164d
Cleared Feb 10, 2020
Dermadry
K192749 · EGJ
Dermadry Laboratories, Inc.
Physical Medicine · 133d
Cleared Feb 10, 2020
InPen System
K192841 · NDC
Companion Medical, Inc.
General Hospital · 130d
Cleared Feb 10, 2020
Argen Clear Aligner, Argen Clear Aligner Premium
K192846 · NXC
Argen Corporation
Dental · 130d
Cleared Feb 10, 2020
Arthrex Mini Comprehensive Fixation System - 1.0mm Screws
K193156 · HWC
Arthrex, Inc.
Orthopedic · 88d
Cleared Feb 10, 2020
MectaFix CL Fixation Button with Continuous Loop
K193165 · MBI
Medacta International S.A.
Orthopedic · 87d
Cleared Feb 10, 2020
Sutter Swyng non-stick bipolar forceps, single-use
K193587 · GEI
Sutter Medizintechnik GmbH
General & Plastic Surgery · 49d
Cleared Feb 10, 2020
cobas Influenza A/B Nucleic acid test for use on the cobas Liat System, cobas...
K200065 · OCC
Roche Molecular Systems, Inc.
Microbiology · 28d
Cleared Feb 10, 2020
M.U.S.T. MINI Posterior Cervical Screws System
K200130 · NKG
Medacta International S.A.
Orthopedic · 20d
Cleared Feb 07, 2020
Pulmonary Cytology Brush
K182927 · BTG
Hobbs Medical, Inc.
Anesthesiology · 473d
Cleared Feb 07, 2020
i-STAT CHEM8+ cartridge with the i-STAT 1 System
K183678 · CGA
Abbott Point of Care, Inc.
Chemistry · 406d
Cleared Feb 07, 2020
i-STAT CHEM8+ cartridge with the i-STAT 1 System
K183688 · JGS
Abbott Point of Care, Inc.
Chemistry · 406d