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

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175,820 results
24889–24912 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 21, 2018
SOLOASSIST II
K171947 · NAY
Aktormed GmbH
General & Plastic Surgery · 449d
Cleared Sep 21, 2018
OpenSight
K172418 · LLZ
Novarad Corporation
Radiology · 407d
Cleared Sep 21, 2018
DePuy Corail AMT Hip Prosthesis
K173960 · LZO
Depuy France S.A.S.
Orthopedic · 267d
Cleared Sep 21, 2018
Malecot Nephrostomy Catheter/Stent Set
K180029 · FAD
Cook Incorporated
Gastroenterology & Urology · 261d
Cleared Sep 21, 2018
Agile Esophageal Stent System
K180144 · ESW
Boston Scientific Corporation
Gastroenterology & Urology · 246d
Cleared Sep 21, 2018
Cellulize
K180338 · OLI
Ward Photonics, LLC
General & Plastic Surgery · 226d
Cleared Sep 21, 2018
TEVADAPTOR Closed Drug Reconstitution and Transfer System
K180489 · ONB
Teva Medical Ltd., Migada Plant
General Hospital · 210d
Cleared Sep 21, 2018
BB-613 Watch Oximeter
K181006 · DQA
Bio-Beat Technologies , Ltd.
Anesthesiology · 158d
Cleared Sep 21, 2018
Pocket Colposcope System
K181034 · HEX
Hadleigh Health Technologies, LLC
Obstetrics & Gynecology · 156d
Cleared Sep 21, 2018
AEROmini Tracheobronchial Stent System
K181200 · JCT
Merit Medical Systems, Inc.
Anesthesiology · 137d
Cleared Sep 21, 2018
PSM 3-Way Silicone Foley Catheter
K181616 · EZL
Pathway, LLC
Gastroenterology & Urology · 94d
Cleared Sep 21, 2018
BD Phoenix Automated Microbiology System - BD Phoenix CPO detect - GN
K181665 · LON
Becton, Dickinson and Company
Microbiology · 88d
Cleared Sep 21, 2018
Tranquil-L Interbody System
K181702 · MAX
Nexus Spine, LLC
Orthopedic · 86d
Cleared Sep 21, 2018
Arthrex FiberTak Suture Anchor
K181769 · MBI
Arthrex, Inc.
Orthopedic · 80d
Cleared Sep 21, 2018
VeriSuite
K181789 · LHN
Medcom GmbH
Radiology · 78d
Cleared Sep 21, 2018
InVivo Web Viewer
K181926 · LLZ
Anatomage, Inc.
Radiology · 65d
Cleared Sep 21, 2018
Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored)
K182043 · LYZ
Hebei Titans Hongsen Medical...
General Hospital · 53d
Cleared Sep 21, 2018
AquaShield System CO2
K182258 · FEQ
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 31d
Cleared Sep 21, 2018
Volpara Imaging Software
K182310 · LLZ
Volpara Health Technologies Limited
Radiology · 28d
Cleared Sep 21, 2018
Spineology Navigation Instruments
K182345 · OLO
Spineology, Inc.
Orthopedic · 24d
Cleared Sep 20, 2018
MicroPort Orthopedics Total Hip Systems MR Labeling
K173898 · LZO
Microport Orthopedics Inc. (Mpo)
Orthopedic · 272d
Cleared Sep 20, 2018
EndoTool SubQ
K180366 · NDC
Al Pacheco and Associates
General Hospital · 220d
Cleared Sep 20, 2018
Katalyst Mark 1 Muscle Stimulation System Model 2
K181199 · NGX
Katalyst, Inc.
Physical Medicine · 136d
Cleared Sep 20, 2018
Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
K181205 · PBK
Centers For Disease Control and...
Microbiology · 136d