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
20809–20832 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 18, 2020
Mixing and Delivery System
K192674 · FMF
Bone Solutions, Inc.
General & Plastic Surgery · 145d
Cleared Feb 18, 2020
Safety Insulin Pen Needle
K192677 · FMI
Jiangsu Caina Medical Co.,Ltd
General Hospital · 145d
Cleared Feb 18, 2020
Vita Flex CR System with LLI
K192894 · MQB
Carestream Health, Inc.
Radiology · 130d
Cleared Feb 18, 2020
MOJAVE Expandable Interbody System
K193203 · MAX
K2m, Inc.
Orthopedic · 90d
Cleared Feb 18, 2020
Ashvins
K200132 · LLZ
Medicalcommunications GmbH
Radiology · 28d
Cleared Feb 18, 2020
Collaboration Live
K200179 · LLZ
Philips Health Care
Radiology · 25d
Cleared Feb 16, 2020
Swan-Ganz Catheters
K193466 · DYG
Edwards Lifesciences, LLC
Cardiovascular · 62d
Cleared Feb 16, 2020
APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 System
K193554 · HRS
Medartis AG
Orthopedic · 58d
Cleared Feb 14, 2020
Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids)
K191346 · GYC
Blackrock Microsystems
Neurology · 270d
Cleared Feb 14, 2020
i-STAT CHEM8+ cartridge with the i-STAT 1 System
K191360 · JFP
Abbott Point of Care, Inc.
Chemistry · 269d
Cleared CT Feb 14, 2020
T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for...
K191364 · JOZ
Fujimori Kogyo, Co., Ltd.
Hematology · 268d
Cleared Feb 14, 2020
The Graft Bone Substitute
K191737 · NPM
Purgo Biologics, Inc.
Dental · 231d
Cleared Feb 14, 2020
Orion LifeSpan MEG
K191785 · OLY
Compumedics Limited
Neurology · 226d
Cleared Feb 14, 2020
Venner PneuX™ ETT (Endotracheal Tube) 6 mm, Venner PneuX™ ETT (Endotracheal...
K192120 · BTR
Venner Medical (Singapore) Pte, Ltd.
Anesthesiology · 192d
Cleared Feb 14, 2020
Maximus System
K192143 · NHJ
Hill-Rom Services Pte, Ltd.
Anesthesiology · 190d
Cleared Feb 14, 2020
CardIQ Flow
K192277 · KPS
GE Medical Systems SCS
Radiology · 176d
Cleared Feb 14, 2020
ASCEND Image Viewer
K192372 · LLZ
Ascend Hit
Radiology · 168d
Cleared Feb 14, 2020
CapsoCam Plus (SV-3) Capsule Endoscopy System
K192662 · NEZ
CapsoVision, Inc.
Gastroenterology & Urology · 142d
Cleared Feb 14, 2020
Vitrea Software Package
K192923 · LLZ
Canon Medical Systems Corporation
Radiology · 121d
Cleared Feb 14, 2020
Real Intelligence Cori
K193120 · OLO
Blue Belt Technologies, Inc.
Orthopedic · 94d
Cleared Feb 14, 2020
Affinity
K193152 · KPS
Hermes Medical Solutions AB
Radiology · 93d
Cleared Feb 14, 2020
Dunamis PunchTac Suture Anchors
K193245 · MBI
Dunamis, LLC
Orthopedic · 81d
Cleared Feb 14, 2020
Biograph Vision, Biograph mCT Family of PET/CTs
K193248 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 81d
Cleared CT Feb 14, 2020
OneTouch Verio Reflect Blood Glucose Monitoring System
K193475 · NBW
Lifescan Europe GmbH
Chemistry · 60d