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
26833–26856 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 01, 2018
The Solstice OCT System
K173047 · NKG
Life Spine, Inc.
Orthopedic · 126d
Cleared Feb 01, 2018
AEON Endoscopic Stapler
K173443 · GDW
Lexington Medical, Inc.
General & Plastic Surgery · 87d
Cleared Feb 01, 2018
ACUSON NX3 Diagnostic Ultrasound System
K173957 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 35d
Cleared Feb 01, 2018
ACUSON P600 Diagnostic Ultrasound System
K180039 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 27d
Cleared Jan 31, 2018
AR_N Type Implant System
K171297 · DZE
Biotem Co., Ltd.
Dental · 274d
Cleared Jan 31, 2018
ODFS Pace XL
K171396 · GZI
Odstock Medical, Ltd.
Neurology · 265d
Cleared Jan 31, 2018
Ecosite Bulk Fill
K171772 · EBF
Dmg USA, Inc.
Dental · 231d
Cleared Jan 31, 2018
SPI Dental Implant System
K172240 · DZE
Msi France
Dental · 189d
Cleared Jan 31, 2018
GORE Molding and Occlusion Balloon Catheter
K172567 · MJN
W. L. Gore and Associates, Inc.
Cardiovascular · 159d
Cleared Jan 31, 2018
da Vinci Xi Surgical System
K172643 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 152d
Cleared Jan 31, 2018
Symetri Clear
K172845 · NJM
Ormco Corporation
Dental · 134d
Cleared Jan 31, 2018
Vitrea Software Toshiba Package VSTP-001A
K173088 · LLZ
Toshibamedical Systems Corporation
Radiology · 124d
Cleared CT Jan 31, 2018
Indego(R)
K173530 · PHL
Parker Hannifin Corporation
Neurology · 77d
Cleared Jan 31, 2018
Merit Syringe
K173601 · FMF
Merit Medical Systems, Inc.
General Hospital · 71d
Cleared Jan 31, 2018
AtriClip FLEX-V
K180010 · FZP
AtriCure, Inc.
General & Plastic Surgery · 29d
Cleared Jan 30, 2018
MiroCam Capsule Endoscope System
K170438 · NEZ
Intromedic Co., Ltd.
Gastroenterology & Urology · 351d
Cleared Jan 30, 2018
Uro-V Cystoscope
K171500 · FAJ
Uroviu Corporation
Gastroenterology & Urology · 252d
Cleared Jan 30, 2018
Irradiation Aesthetic Device
K171835 · OAP
Chongqing Peninsula Medical...
General & Plastic Surgery · 224d
Cleared Jan 30, 2018
Getinge GSS67N Series Steam Sterilizer
K172159 · FLE
Maquet GmbH
General Hospital · 196d
Cleared Jan 30, 2018
Rex Medical Aspiration Pump
K173389 · BTA
Rex Medical, L.P.
General & Plastic Surgery · 92d
Cleared Jan 30, 2018
Zimmer Persona Personalized Knee System
K173417 · MBH
Zimmer, Inc.
Orthopedic · 90d
Cleared Jan 30, 2018
Luma Light System
K173436 · FTC
Luma Therapeutics
General & Plastic Surgery · 88d
Cleared Jan 29, 2018
40-42mm BiPolar Head and 22mm Femoral Head
K163081 · KWY
Signature Orthopaedics Pty, Ltd.
Orthopedic · 452d
Cleared Jan 29, 2018
JOULE SYSTEM
K173285 · GEX
Sciton, Inc
General & Plastic Surgery · 105d