Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
35209–35232 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 28, 2015
Compex Wireless USA
K143551 · NGX
Djo, LLC
Physical Medicine · 134d
Cleared Apr 28, 2015
S30/S40 Digital Color Doppler Ultraound System
K150045 · IYN
Sonoscape Company Limited
Radiology · 106d
Cleared Apr 28, 2015
BD FlowSmart Set
K150059 · FPA
Becton, Dickinson Company
General Hospital · 105d
Cleared Apr 28, 2015
Facet-Link Stabilization Platform
K150223 · MRW
Facet-Link, Inc.
Orthopedic · 88d
Cleared Apr 28, 2015
Streamline OCT Occipito-Cervico-Thoracic System
K150254 · KWP
Pioneer Surgical Technology, Inc....
Orthopedic · 84d
Cleared Apr 28, 2015
KYPHON (R) HV-R(R) Bone Cement
K150460 · NDN
Medtronic Sofamor Danck USA, Inc.
Orthopedic · 64d
Cleared Apr 28, 2015
JUSHA-M53 Medical Display
K150842 · PGY
Nanjing Jusha Display Technology Co.,...
Radiology · 29d
Cleared Apr 27, 2015
Medline Enteral Feeding Sets
K150286 · PIF
Medline Industries, Inc.
Gastroenterology & Urology · 81d
Cleared Apr 24, 2015
KI-20
K141482 · EBW
Saeyang Microtech Co., Ltd.
Dental · 324d
Cleared Apr 24, 2015
YARLAP
K141643 · KPI
International Trade Group, Inc.
Gastroenterology & Urology · 309d
Cleared Apr 24, 2015
SILHOUETTE INSTALIFT
K142061 · GAM
Silhouette Lift, Inc.
General & Plastic Surgery · 268d
Cleared Apr 24, 2015
Luminesse PMMA
K142371 · EBG
Talladium, Inc.
Dental · 242d
Cleared Apr 24, 2015
Neuromaster G1 MEE200
K142624 · GWF
Nihon Kohden Corporation
Neurology · 220d
Cleared Apr 24, 2015
Flexible 19G EBUS Needle
K142909 · EOQ
Spiration, Inc.
Ear, Nose, Throat · 200d
Cleared Apr 24, 2015
EndoTool SubQ
K142918 · NDC
Monarch Medical Technologies
General Hospital · 199d
Cleared Apr 24, 2015
C3 Wave
K143238 · LJS
Medcomp ( Medical Components)
General Hospital · 163d
Cleared Apr 24, 2015
Aespire View
K143530 · BSZ
Datex-Ohmeda, Inc.
Anesthesiology · 133d
Cleared CT Apr 24, 2015
Lipofina Laser System
K143741 · OLI
Yolo Medical, Inc.
General & Plastic Surgery · 114d
Cleared Apr 24, 2015
SpineFrontier SIJFuse Sacroiliac Joint Fusion Device System
K150017 · OUR
Spinefrontier, Inc.
Orthopedic · 109d
Cleared Apr 24, 2015
Artoura Breast Tissue Expander
K150777 · LCJ
Mentor Worldwide, LLC
General & Plastic Surgery · 30d
Cleared Apr 24, 2015
Healgen Secobarbital Test(Strip, Cassette, Cup, Dip Card), Healgen...
K150791 · DIS
Healgen Scientific, LLC
Toxicology · 30d
Cleared Apr 24, 2015
Codent Low Speed Dental Handpieces and Accessories
K150798 · EFB
Codent Technical Industry Co., Ltd.
Dental · 29d
Cleared Apr 24, 2015
syngo®.via (version VB10A)
K150843 · LLZ
Siemens AG
Radiology · 25d
Cleared Apr 23, 2015
INTERBODY CAGE
K140348 · MAX
Eisertech, LLC
Orthopedic · 436d