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
19849–19872 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 15, 2020
CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope...
K201313 · FTM
Aziyo Biologics, Inc.
General & Plastic Surgery · 28d
Cleared Jun 15, 2020
Centurion POCT System
K201481 · NKG
Orthofix, Inc.
Orthopedic · 11d
Cleared Jun 13, 2020
STERIS Patient Warming System
K200446 · DWJ
STERIS Corporation
Cardiovascular · 110d
Cleared Jun 12, 2020
Electrical Stimulator System
K192201 · NUH
Gymmax Technology Shenzen Co., Ltd.
Neurology · 304d
Cleared Jun 12, 2020
MAMMOMAT Revelation
K193166 · MUE
Siemens Medical Solutions USA, Inc.
Radiology · 210d
Cleared Jun 12, 2020
FreeStyle Libre 2 Flash Glucose Monitoring System
K193371 · QLG
Abbott Diabetes Care, Inc.
Chemistry · 190d
Cleared Jun 12, 2020
Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe
K193379 · DXE
Edwards Lifesciences, LLC
Cardiovascular · 190d
Cleared Jun 12, 2020
Full Automatic(NIBP) Blood Pressure Monitor
K200521 · DXN
Health & Life Co., Ltd.
Cardiovascular · 102d
Cleared Jun 12, 2020
INSPIRE 7FM Hollow fiber oxygenator with integrated arterial filter, INSPIRE...
K200683 · DTZ
Sorin Group Italia S.R.L.
Cardiovascular · 88d
Cleared Jun 12, 2020
Kubtec Mozart Supra
K200756 · MWP
Kub Technologies, Inc.
Radiology · 80d
Cleared Jun 12, 2020
Hemo Control (optional Add Pack Hemo Control DM)
K200909 · GKR
Ekf Diagnostic GmbH
Hematology · 67d
Cleared Jun 12, 2020
REAL INTELLIGENCE CORI (CORI)
K201022 · OLO
Blue Belt Technologies, Inc.
Orthopedic · 53d
Cleared Jun 12, 2020
ExpanSure Large Access Transseptal Dilator
K201288 · DRE
Baylis Medical Company, Inc.
Cardiovascular · 29d
Cleared Jun 11, 2020
uWS-MI
K192630 · LLZ
Shanghai United Imaging Healthcare...
Radiology · 262d
Cleared Jun 11, 2020
physIQ Heart Rhythm and Respiration Module
K193415 · DPS
Physiq, Inc.
Cardiovascular · 185d
Cleared Jun 11, 2020
MEDO ARIA
K200356 · QIH
Medo.Ai
Radiology · 119d
Cleared Jun 11, 2020
E>EyeC
K200616 · ONF
E-Swin
General & Plastic Surgery · 94d
Cleared Jun 11, 2020
RIGEL 3DR Anterior Cervical Interbody Fusion System
K200685 · ODP
MiRus, LLC
Orthopedic · 87d
Cleared Jun 11, 2020
Auto 3D Bladder Volume Tool
K200980 · IYO
Butterfly Network, Inc.
Radiology · 58d
Cleared Jun 11, 2020
Versana Active
K200998 · IYN
GE Medical Systems Ultrasound and...
Radiology · 56d
Cleared Jun 11, 2020
In-Ka Ureteral Balloon Dilatation Catheter
K201007 · EZN
Coloplast Corp.
Gastroenterology & Urology · 55d
Cleared Jun 11, 2020
Gold Anchor
K201117 · IYE
Naslund Medical AB
Radiology · 45d
Cleared Jun 11, 2020
Benchmark BMX96 Access System
K201271 · DQY
Penumbra, Inc.
Neurology · 30d
Cleared Jun 10, 2020
Auxein Nailing System
K192003 · JDS
Auxein Medical Private Limited
Orthopedic · 320d