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
28537–28560 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jul 18, 2017
20G x 5/8 Pro-Lock CT Safety Infusion Set
K171333 · PTI
Medcomp (Dba Medical Components, Inc.)
General Hospital · 71d
Cleared Jul 18, 2017
Arterys Viewer
K171544 · LLZ
Arterys, Inc.
Radiology · 53d
Cleared Jul 18, 2017
ES2 Neuromonitoring Accessory Instruments
K171807 · PDQ
Stryker Corporation
Neurology · 29d
Cleared Jul 18, 2017
Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound...
K171824 · IYO
Edan Instruments, Inc.
Radiology · 29d
Cleared Jul 18, 2017
Inspire ICE aka Inspire ICE Clear Brackets
K171844 · NJM
Ormco Corporation
Dental · 28d
Cleared Jul 17, 2017
U2 Femoral Head
K162957 · LPH
United Orthopedic Corporation
Orthopedic · 266d
Cleared Jul 17, 2017
BD ChloraShield IV Dressing with CHG Antimicrobial
K170407 · FRO
Avery Dennison Belgie Bvba
General & Plastic Surgery · 157d
Cleared Jul 17, 2017
!M1
K170607 · IZL
Solutions For Tomorrow AB
Radiology · 138d
Cleared Jul 17, 2017
Genius Total Knee System
K170613 · JWH
Signature Orthopaedics Pty, Ltd.
Orthopedic · 138d
Cleared Jul 17, 2017
3D Endo Software
K171115 · LLZ
Dentsply Sirona
Radiology · 94d