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
19321–19344 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 20, 2020
Electronic Blood Pressure Monitor
K200939 · DXN
Jiangsu Yuyue Medical Equipment&...
Cardiovascular · 134d
Cleared Aug 20, 2020
Hercules Suture Anchor System
K201636 · MBI
In2bones USA, LLC
Orthopedic · 65d
Cleared Aug 20, 2020
FUJIFILM Video Laparoscope
K202130 · GCJ
Fujifilm Corporation
General & Plastic Surgery · 20d
Cleared CT Aug 19, 2020
invisa-RED ELITE
K192275 · OLI
IR Technology, LLC
General & Plastic Surgery · 363d
Cleared Aug 19, 2020
VariLymph 12 pro
K193476 · JOW
Slk Medical GmbH
Cardiovascular · 247d
Cleared Aug 19, 2020
Omnichroma Flow
K193537 · EBF
Tokuyama Dental Corporation
Dental · 243d
Cleared Aug 19, 2020
Medline ReNewal Reprocessed Harmonic ACE+7 Shears
K193563 · NLQ
Surgical Instrument Service and...
General & Plastic Surgery · 240d
Cleared Aug 19, 2020
Indigo Aspiration System - Aspiration Catheter 7 and Separator 7
K193595 · QEW
Penumbra, Inc.
Cardiovascular · 240d
Cleared Aug 19, 2020
HemosIL von Willebrand Factor Antigen
K200033 · GGP
Instrumentation Laboratory CO
Hematology · 225d
Cleared Aug 19, 2020
Sirona Dental CAD/CAM System with InLab Software
K200191 · PNP
Dentsply Sirona
Dental · 205d
Cleared Aug 19, 2020
Straumann BLX Gold Abutments
K200597 · NHA
Straumann USA, LLC (On Behalf of...
Dental · 163d
Cleared Aug 19, 2020
Asept Surgical Face Mask
K201137 · FXX
Pfm Medical, Inc.
General Hospital · 113d
Cleared Aug 19, 2020
Reusable and Disposable SpO2 Sensors
K201360 · DQA
Xinkang Medical Instrument Co. , Ltd.
Anesthesiology · 90d
Cleared Aug 19, 2020
CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™...
K201362 · PML
Medtronic
Orthopedic · 89d
Cleared Aug 19, 2020
CUBEScan BioCon-1100
K201995 · IYO
Mcube Technology Co., Ltd.
Radiology · 30d
Cleared Aug 19, 2020
Cranial 4Pi Immobilization
K202050 · IYE
Brainlab AG
Radiology · 26d
Cleared Aug 18, 2020
ORION Spinal System
K190600 · NKB
Orion Biotech, Inc.
Orthopedic · 529d
Cleared Aug 18, 2020
BB Base 3D printing resin for denture base
K191591 · EBI
Enlighten Materials Co., Ltd.
Dental · 431d
Cleared Aug 18, 2020
Coloring Liquid
K192723 · EIH
Aidite (Qinhuangdao) Technology Co.,...
Dental · 326d
Cleared Aug 18, 2020
Keystone Dental XL Dental Implant System
K201334 · DZE
Keystone Dental, Inc.
Dental · 90d
Cleared Aug 18, 2020
Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System
K202012 · KNW
Devicor Medical Products, Inc.
General & Plastic Surgery · 28d
Cleared Aug 17, 2020
Cytrans Granules
K192597 · LYC
GC America, Inc.
Dental · 332d
Cleared Aug 17, 2020
Sperm Freeze, Sperm Fridge
K192845 · MQL
Kitazato Corporation
Obstetrics & Gynecology · 319d
Cleared Aug 17, 2020
Universal Cylinder Applicator Family
K193240 · JAQ
Varian Medical Systems, Inc.
Radiology · 266d