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
27937–27960 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 20, 2017
GelPOINT Path Transanal Access Platform
K171701 · FER
Applied Medical Resources Corp.
Gastroenterology & Urology · 42d
Cleared Jul 19, 2017
Dario Blood Glucose Monitoring System
K163159 · NBW
Labstyle Innovations, Ltd.
Chemistry · 251d
Cleared Jul 19, 2017
XPress BCD Breast Compression Device
K163388 · POY
Xpress Bcd, LLC
General & Plastic Surgery · 229d
Cleared Jul 19, 2017
OLINDA EXM
K163687 · IYX
Hermes Medical Solutions AB
Radiology · 203d
Cleared Jul 19, 2017
CARDIOVIT FT-1
K170182 · DPS
Schiller AG
Cardiovascular · 177d
Cleared Jul 19, 2017
Disposable Standard Clamp
K170379 · GCJ
Standard Bariatrics
General & Plastic Surgery · 162d
Cleared Jul 19, 2017
Graftgun Universal Graft Delivery System
K170675 · FMF
SurGenTec, LLC
General Hospital · 135d
Cleared Jul 19, 2017
Mini Stick ENVI Non-Vascular Introducer Kit
K170775 · DYB
AngioDynamics, Inc.
Cardiovascular · 127d
Cleared Jul 19, 2017
POD Packing Coil
K170852 · HCG
Penumbra, Inc.
Neurology · 119d
Cleared Jul 19, 2017
Embrace Neonatal MRI System
K170978 · LNH
Aspect Imaging, Ltd.
Radiology · 107d
Cleared Jul 19, 2017
STERILE NITRILE PATIENT EXAMINATION GLOVES, POWDERFREE
K171093 · LZA
Sanrea Healthcare Products Pvt, Ltd.
General Hospital · 98d
Cleared Jul 19, 2017
Vela RX PTA Balloon Dilatation Catheter
K171290 · LIT
Curatia Medical
Cardiovascular · 78d
Cleared Jul 19, 2017
Nio Color 2MP (MDNC-2123)
K171812 · PGY
Barco N.V.
Radiology · 30d
Cleared Jul 19, 2017
TiLock2 Spinal System
K171838 · NKB
Genesys Spine
Orthopedic · 29d
Cleared Jul 19, 2017
MaxZero Extension Sets with Needless Connector
K171957 · FPA
Carefusion 303, Inc.
General Hospital · 20d
Cleared Jul 18, 2017
Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue
K162510 · LZA
Ug Global Resources Sdn. Bhd.
General Hospital · 313d
Cleared Jul 18, 2017
Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE)
K162856 · EGS
Bonart Co., Ltd.
Dental · 279d
Cleared Jul 18, 2017
Demi Ultra
K163064 · EBZ
Kerr Corporation
Dental · 258d
Cleared Jul 18, 2017
OSSIX BONE
K163714 · NPM
Datum Dental, Ltd.
Dental · 200d
Cleared Jul 18, 2017
CreoDent Solidex Customized Abutment and Screw
K170100 · NHA
Creodent Prosthetics, Ltd.
Dental · 188d
Cleared Jul 18, 2017
Examion X-AQS
K170729 · LLZ
Examion GmbH
Radiology · 131d
Cleared Jul 18, 2017
Faxitron Bioptics Speciemen Radiography System
K170786 · MWP
Faxitron Bioptics, LLC
Radiology · 124d
Cleared Jul 18, 2017
JO Agapé Personal Lubricant
K171021 · NUC
United Consortium
Obstetrics & Gynecology · 104d
Cleared Jul 18, 2017
Altrix Temperature Management Wraps
K171149 · DWJ
Stryker Medical
Cardiovascular · 90d