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
20473–20496 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 26, 2020
Stryker Customized Mandible Recon Plate Kit
K193136 · JEY
Stryker
Dental · 134d
Cleared Mar 26, 2020
Stryker Facial iD Plating System
K193143 · JEY
Stryker
Dental · 134d
Cleared Mar 26, 2020
KOSMOS
K193518 · IYN
EchoNous, Inc.
Radiology · 98d
Cleared Mar 26, 2020
APTUS® Ankle Trauma System 2.8/3.5
K193633 · HRS
Medartis AG
Orthopedic · 90d
Cleared Mar 26, 2020
APTUS® Foot 2.8-3.5 System
K193639 · HRS
Medartis AG
Orthopedic · 90d
Cleared Mar 26, 2020
AbClose - Port Site Closure Device
K193652 · OCW
Medeon Biodesign, Inc.
General & Plastic Surgery · 87d
Cleared Mar 26, 2020
GEO 1st MTP Joint Arthrodesis Plating System
K200108 · HRS
Gramercy Extremity Orthopedics, LLC
Orthopedic · 69d
Cleared Mar 26, 2020
Becker External Drainage and Monitoring System
K200456 · GWM
Medtronic, Inc.
Neurology · 30d
Cleared Mar 25, 2020
LaserShot M, NaviLase
K192008 · MRX
Vitrolife GmbH
Obstetrics & Gynecology · 240d
Cleared Mar 25, 2020
STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device
K192144 · NEW
Ethicon, Inc.
General & Plastic Surgery · 230d
Cleared Mar 25, 2020
DiaFil Flow
K192284 · EBF
DiaDent Group International
Dental · 216d
Cleared Mar 25, 2020
Arterys MICA
K192437 · QIH
Arterys, Inc.
Radiology · 201d
Cleared Mar 25, 2020
CrossBay Endometrial Tissue Sampler (ETS)
K192534 · HHK
Crossbay Medical
Obstetrics & Gynecology · 191d
Cleared Mar 25, 2020
MammoScreen
K192854 · QDQ
Therapixel
Radiology · 173d
Cleared Mar 25, 2020
Medacta Shoulder System
K192967 · PHX
Medacta International S.A.
Orthopedic · 154d
Cleared Mar 25, 2020
MIS CONNECT Conical Connection System
K193078 · NHA
Dentsply Sirona
Dental · 141d
Cleared Mar 25, 2020
Aluna
K193311 · BZH
Knox Medical Diagnostics, Inc.
Anesthesiology · 117d
Cleared Mar 25, 2020
IPL + Diode Laser Machine
K193328 · ONF
Beijing Globalipl Development Co., Ltd.
General & Plastic Surgery · 114d
Cleared Mar 25, 2020
NuVasive 3DP Interfixated ALIF System
K193593 · OVD
Nu Vasive, Incorporated
Orthopedic · 93d
Cleared Mar 25, 2020
FINE Osteotomy around the knee
K193614 · HRS
Bodycad Laboratories, Inc.
Orthopedic · 90d
Cleared Mar 25, 2020
NorthStar™ OCT Spinal System
K193615 · NKG
SeaSpine Orthopedics Corporation
Orthopedic · 90d
Cleared Mar 25, 2020
Cry-Ac®, Cry-Ac-3®, Cry-Baby
K193619 · GEH
Brymill Cryogenic Systems
General & Plastic Surgery · 90d
Cleared Mar 25, 2020
Disposable NIBP Cuff
K193629 · DXQ
Shenzhen Changke Connect Electronics...
Cardiovascular · 90d
Cleared Mar 25, 2020
LightWalker Laser System Family
K193661 · GEX
Fotona D.O.O.
General & Plastic Surgery · 86d