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
26569–26592 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 02, 2018
Footmotion HammerToe
K172485 · HTY
Newclip Technics
Orthopedic · 197d
Cleared Mar 02, 2018
Spectra Optia Apheresis System
K172590 · LKN
Terumobct, Inc.
Gastroenterology & Urology · 185d
Cleared Mar 02, 2018
Next Generation iBOT
K172601 · IMK
Deka Research & Development Corp.
Physical Medicine · 184d
Cleared Mar 02, 2018
Wrist Type Automatic Blood Pressure Monitor
K172972 · DXN
Shenzhen Jiacom Technology CO ., Ltd.
Cardiovascular · 157d
Cleared Mar 02, 2018
ologen Collagen Matrix
K173223 · KGN
Aeon Astron Europe B.V.
General & Plastic Surgery · 150d
Cleared Mar 02, 2018
System 1 endo Liquid Chemical Sterilant Processing System
K173256 · MED
STERIS Corporation
General Hospital · 143d
Cleared Mar 02, 2018
LigaSure Exact Dissector, Nano-coated
K173281 · GEI
Covidien
General & Plastic Surgery · 137d
Cleared Mar 02, 2018
ProBx Software
K173312 · LLZ
Harmonus, Inc.
Radiology · 134d
Cleared Mar 02, 2018
LENSAR Laser System - fs 3D (LLS-fs 3D)
K173346 · OOE
Lensar, Inc.
Ophthalmic · 128d
Cleared Mar 02, 2018
VERIFY Chemical Indicator for S40 Sterilant
K173428 · JOJ
STERIS Corporation
General Hospital · 120d
Cleared Mar 02, 2018
V.A.C.VIA 7 Day Therapy System Kit, V.A.C.VIA Therapy Starter Kit, V.A.C.VIA...
K173447 · OMP
Kci USA, Inc.
General & Plastic Surgery · 116d
Cleared Mar 02, 2018
Phoenix Wound Matrix
K173544 · QSZ
Nanofiber Solutions, Inc.
General & Plastic Surgery · 106d
Cleared Mar 02, 2018
ORIGIO® Handling™ without phenol red (Cat. No. 8310), ORIGIO® Handling™ with...
K173624 · MQL
Origio A/S
Obstetrics & Gynecology · 98d
Cleared Mar 02, 2018
ImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP Tryptase Curve...
K173704 · OYL
Phadia AB
Immunology · 88d
Cleared Mar 02, 2018
SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming...
K173731 · MQL
CooperSurgical, Inc.
Obstetrics & Gynecology · 86d
Cleared Mar 02, 2018
COMPACT TOUCH Ophthalmic Ultrasound System
K180265 · IYO
Quantel Medical
Radiology · 30d
Cleared Mar 01, 2018
PUMA System
K171703 · HTN
Panther Orthopedics, Inc.
Orthopedic · 266d
Cleared Mar 01, 2018
Nathanson Transcystic Bile Duct Stone Exploration Pack
K171915 · LQR
Cook Incorporated
Gastroenterology & Urology · 248d
Cleared Mar 01, 2018
Technoweb Surgical Mask
K172500 · FXX
Yts Global, Inc.
General Hospital · 195d
Cleared Mar 01, 2018
Microscope Navigation Software
K172820 · HAW
Brainlab AG
Neurology · 164d
Cleared Mar 01, 2018
FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and...
K172916 · FDS
Fujifilm Corporation
Gastroenterology & Urology · 157d
Cleared Mar 01, 2018
CELERITY 20 HP Challenge Pack
K173488 · FRC
STERIS Corporation
General Hospital · 108d
Cleared CT Mar 01, 2018
Sapphire II PRO
K173680 · LOX
Orbusneich Medical Trading, Inc.
Cardiovascular · 90d
Cleared Mar 01, 2018
Arthrex Corkscrew FT
K173788 · MAI
Arthrex, Inc.
Orthopedic · 77d