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
24241–24264 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 10, 2018
SabreLine and SabreGuard Laser Fibers
K182831 · GEX
Coloplast Corp.
General & Plastic Surgery · 62d
Cleared Dec 10, 2018
Mega Plus Spine System
K183080 · NKB
Bk Meditech, Co., Ltd.
Orthopedic · 35d
Cleared Dec 07, 2018
Neck Care Therapy, Model: SYK 509B
K172897 · NUH
Shenzhen Osto Technology Co., Ltd.
Neurology · 441d
Cleared Dec 07, 2018
SignalMark Lung Biopsy Site Marker
K180175 · GDW
View Point Medical, Inc.
General & Plastic Surgery · 319d
Cleared Dec 07, 2018
Resin for Temporary Crown & Bridge
K180657 · EBG
Dentis Co., Ltd.
Dental · 269d
Cleared Dec 07, 2018
ICONN Campbell Interference Screw
K180670 · HWC
Iconn Orthopedics, LLC
Orthopedic · 268d
Cleared Dec 07, 2018
CitriCon Liquid and Powder (Acid Concentrate acidified with Citric Acid),...
K180679 · KPO
Global Scientific Technologies, LLC
Gastroenterology & Urology · 267d
Cleared Dec 07, 2018
C-Zero Pedicle Screw System, Freedom Pedicle Screw System
K180754 · NKB
Signature Orthopaedics Pty, Ltd.
Orthopedic · 260d
Cleared Dec 07, 2018
Tractus Crossing Support Catheter
K180889 · DQY
Tractus Vascular, LLC
Cardiovascular · 247d
Cleared Dec 07, 2018
Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use...
K181583 · BTM
Flexicare Medical Limited.
Anesthesiology · 175d
Cleared Dec 07, 2018
Nihon Kohden NKV-550 Series Ventilator System
K181695 · CBK
Nihon Kohden Orangemed, Inc.
Anesthesiology · 163d
Cleared Dec 07, 2018
Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System
K182007 · OVD
Renovis Surgical Technologies
Orthopedic · 133d
Cleared Dec 07, 2018
Avenir Complete Hip System
K182048 · LZO
Zimmer, Inc.
Orthopedic · 129d
Cleared Dec 07, 2018
GC70, GU60A, GU60A-65, GF50, GR50A
K182183 · KPR
Samsung Electronics Co., Ltd.
Radiology · 116d
Cleared Dec 07, 2018
FiXcision
K182664 · KOA
Agency For Medical Innovations GmbH
Gastroenterology & Urology · 73d
Cleared Dec 07, 2018
CUSA Clarity Ultrasonic Surgical Aspirator System
K182809 · LFL
Integra LifeSciences Corporation
General & Plastic Surgery · 65d
Cleared Dec 07, 2018
Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen...
K183100 · MYA
Leica Biosystems Newcastle, Limited
Pathology · 30d
Cleared Dec 07, 2018
BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) ,...
K183102 · MXZ
Leica Biosystems Newcastle, Limited
Pathology · 30d
Cleared Dec 07, 2018
Contour 24
K183111 · MOS
Quality Electrodynamics, LLC
Radiology · 29d
Cleared Dec 07, 2018
Nexus DR Digital X-ray Imaging System with stitching
K183212 · MQB
Varex Imaging Corporation
Radiology · 18d
Cleared Dec 07, 2018
17HK701G-W
K183286 · MQB
Lg Electronics.Inc
Radiology · 11d
Cleared Dec 06, 2018
RII Smart IR Thermometer
K163601 · FLL
Radiant Innovation, Inc.
General Hospital · 715d
Cleared Dec 06, 2018
No-contact Forehead Thermometer
K173048 · FLL
Dongguan Simzo Electronic Technology...
General Hospital · 434d
Cleared Dec 06, 2018
AMRA Profiler
K173749 · LNH
Amra Medical AB
Radiology · 363d