FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
19873–19896 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 26, 2020
Konan Specular Microscope XVII
K191558 · NQE
Konan Medical, Inc.
Ophthalmic · 288d
Cleared Mar 26, 2020
TIGR Matrix Surgical Mesh, TIGR Surgical Mesh
K191749 · OWT
Novus Scientific AB
General & Plastic Surgery · 269d
Cleared Mar 26, 2020
gammaCore Sapphire
K191830 · PKR
Electrocore, Inc.
Neurology · 261d
Cleared Mar 26, 2020
Propeller Sensor for Symbicort
K192724 · CAF
Reciprocal Labs Corporation
Anesthesiology · 181d
Cleared Mar 26, 2020
BodyGuardian Remote Monitoring System
K192732 · DSI
Preventice Technologies, Inc.
Cardiovascular · 181d
Cleared Mar 26, 2020
OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide...
K192886 · DQX
Volcano Corporation
Cardiovascular · 168d
Cleared Mar 26, 2020
Ellipse Frax 1940 for Ellipse Nordlys and Ellipse Ydun
K192951 · GEX
Ellipse A/S
General & Plastic Surgery · 157d
Cleared Mar 26, 2020
Aina HbA1c Monitoring System 2
K192987 · LCP
Jana Care, Inc.
Chemistry · 153d
Cleared Mar 26, 2020
Tina-quant Hemoglobin A1cDx Gen.3
K193053 · PDJ
Roche Diagnostics Operations (Rdo)
Chemistry · 146d
Cleared Mar 26, 2020
Bonecam Suture Anchor
K193108 · MBI
Valeris Medical, Inc.
Orthopedic · 139d
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