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
18481–18504 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 07, 2020
Impella XR Sheath Set
K202330 · DYB
Abiomed, Inc.
Cardiovascular · 112d
Cleared CT Dec 07, 2020
BNA Platform
K202588 · OLU
Elminda, Ltd.
Neurology · 90d
Cleared Dec 07, 2020
GIA Stapler with Tri-Staple Technology
K202701 · GDW
Covidien
General & Plastic Surgery · 82d
Cleared Dec 07, 2020
Ophthalmic Yag Laser System YC-200
K203130 · HQF
Nidek Co., Ltd.
Ophthalmic · 49d
Cleared Dec 07, 2020
3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator
K203284 · QKM
3M Company
General Hospital · 28d
Cleared Dec 06, 2020
Transtek Wrist Blood Pressure Monitor
K202599 · DXN
Guangdong Transtek Medical...
Cardiovascular · 89d
Cleared Dec 05, 2020
DVT-2600
K203016 · JOW
Daesung Maref Co., Ltd.
Cardiovascular · 65d
Cleared Dec 04, 2020
Vagisan MoistCream Cremolum
K193444 · NUC
Dr. August Wolff GmbH & Co. KG...
Obstetrics & Gynecology · 358d
Cleared Dec 04, 2020
Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20
K193508 · JTN
Oxoid Limited (Part of Thermo Fisher...
Microbiology · 352d
Cleared Dec 04, 2020
Dynamic Gas Scavenging System 2 (DGSS - 2)
K193646 · CBN
Anesthetic Gas Reclamation, Inc.
Anesthesiology · 340d
Cleared Dec 04, 2020
InBody
K200442 · DXN
Inbody Co., Ltd.
Cardiovascular · 284d
Cleared Dec 04, 2020
TubeClear System
K200646 · KNT
Actuated Medical, Inc.
Gastroenterology & Urology · 267d
Cleared Dec 04, 2020
Electronic Blood Pressure Monitor
K200716 · DXN
Shenzhen Pango Electronic Co., Ltd.
Cardiovascular · 261d
Cleared Dec 04, 2020
LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal System
K200789 · NKB
L & K Biomed Co., Ltd.
Orthopedic · 253d
Cleared Dec 04, 2020
Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program...
K200876 · QBJ
Dexcom, Inc.
Chemistry · 247d
Cleared Dec 04, 2020
TTBIO EVOCLEAN Ultrasonic Scaler
K201317 · ELC
Ttbio Corp.
Dental · 200d
Cleared Dec 04, 2020
FlowTriever Retrieval/Aspiration System
K201541 · QEW
Inari Medical
Cardiovascular · 178d
Cleared Dec 04, 2020
Neocis Guidance System (NGS) with Yomi Plan v2.0
K202264 · PLV
Neocis, Inc.
Dental · 115d
Cleared Dec 04, 2020
HealthJOINT
K202487 · LLZ
Zebra Medical Vision, Ltd.
Radiology · 95d
Cleared Dec 04, 2020
GoSpiro
K202837 · BZG
Monitored Therapeutics, Inc.
Anesthesiology · 70d
Cleared Dec 04, 2020
Nucleus.io
K203249 · LLZ
Nucleushealth, LLC
Radiology · 30d
Cleared Dec 03, 2020
Tricoglam Home Use
K193008 · OAP
Advihair S.R.L.
General & Plastic Surgery · 402d
Cleared Dec 03, 2020
ORISE ProKnife
K200404 · KNS
Boston Scientific Corporation
Gastroenterology & Urology · 288d
Cleared Dec 03, 2020
AireHealth NebulizerTM
K201167 · CAF
Airehealth, Inc.
Anesthesiology · 216d