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
26425–26448 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 19, 2018
CapLOX II® / TowerLOX® MIS Pedicle Screw System
K180475 · NKB
Captiva Spine, Inc.
Orthopedic · 25d
Cleared Mar 19, 2018
Ezee Retrieval
K180579 · GCJ
Genicon, Inc.
General & Plastic Surgery · 14d
Cleared Mar 18, 2018
AXS Catalyst Distal Access Catheter 058 x 115cm
K173841 · NRY
Stryker
Neurology · 90d
Cleared Mar 16, 2018
TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges
K171542 · LFD
Dr. Harold Katz, LLC (Dba Therabreath
Dental · 294d
Cleared Mar 16, 2018
SOFTXIL
K171851 · MIB
Bistool
General & Plastic Surgery · 268d
Cleared Mar 16, 2018
Microlife Upper Arm Automatic Digital Blood Pressure Monitor
K171937 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 261d
Cleared Mar 16, 2018
Wrist Pulse Oximeter
K172366 · DQA
Beijing Choice Electronic Technology...
Anesthesiology · 224d
Cleared Mar 16, 2018
SurgiQuest AIRSEAL iFS System
K172516 · HIF
Conmed Corporation
Obstetrics & Gynecology · 207d
Cleared Mar 16, 2018
XCelliStem Wound Powder
K172593 · KGN
Stemsys
General & Plastic Surgery · 199d
Cleared Mar 16, 2018
Portable X-ray System
K172928 · EHD
Rolence Enterprise, Inc.
Radiology · 172d
Cleared Mar 16, 2018
CCM Abutment System
K173120 · NHA
Innobiosurg Co., Ltd.
Dental · 168d
Cleared CT Mar 16, 2018
ExSpiron 1Xi
K173181 · BZK
Respiratory Motion, Inc.
Anesthesiology · 168d
Cleared Mar 16, 2018
MIS CONNECT Conical Connection Abutment
K173326 · NHA
Mis Implants Technologies , Ltd.
Dental · 147d
Cleared CT Mar 16, 2018
ARTAS System
K173358 · ONA
Restoration Robotics, Inc.
General & Plastic Surgery · 142d
Cleared Mar 16, 2018
syngo Application Software
K173611 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 114d
Cleared Mar 16, 2018
SI Screw System
K173752 · OUR
Zavation Medical Products, LLC
Orthopedic · 98d
Cleared Mar 16, 2018
Xpert CT/NG
K173840 · LSL
Cepheid
Microbiology · 88d
Cleared Mar 16, 2018
BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins...
K173873 · MDB
Becton, Dickinson and Company
Microbiology · 86d
Cleared Mar 16, 2018
Imbio Segmentation Editing Tool software
K180129 · LLZ
Imbio, LLC
Radiology · 58d
Cleared Mar 16, 2018
FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible...
K180172 · HQD
Paragon Vision Sciences
Ophthalmic · 53d
Cleared Mar 16, 2018
Frigitronics adapter
K180195 · HRN
Phakos
Ophthalmic · 51d
Cleared Mar 16, 2018
3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System
K180404 · NJM
3M Healthcare
Dental · 30d
Cleared Mar 16, 2018
MEMO 4D
K180411 · KRH
Sorin Group Italia S.R.L.
Cardiovascular · 29d
Cleared Mar 16, 2018
Empower H35
K180426 · GEX
Quanta System Spa
General & Plastic Surgery · 28d