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
26953–26976 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 16, 2018
ACCLARENT AERA Eustachian Tube Balloon Dilation System
K171761 · PNZ
Acclarent, Inc.
Ear, Nose, Throat · 216d
Cleared Jan 16, 2018
Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial Arzzt, Ins Hilden...
K172189 · HSB
Truemed Group, LLC
Orthopedic · 180d
Cleared Jan 16, 2018
Quickie(r) Q700-UP M
K172384 · IPL
Sunrise Medical (Us), LLC
Physical Medicine · 161d
Cleared Jan 16, 2018
Yamahachi Pink CAD/CAM Disk
K172683 · EBI
YAMAHACHI DENTAL MFG., Co.
Dental · 132d
Cleared Jan 16, 2018
Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel
K172977 · KLE
Nanova Biomaterials, Inc.
Dental · 111d
Cleared Jan 16, 2018
Navigo Workstation Version 2.0
K173054 · LLZ
UC-CARE , Ltd.
Radiology · 110d
Cleared Jan 16, 2018
Arthrex PushLock
K173240 · MAI
Arthrex, Inc.
Orthopedic · 103d
Cleared Jan 16, 2018
CS Imaging
K173622 · LLZ
Trophy
Radiology · 53d
Cleared Jan 16, 2018
Activ Ankle
K173641 · HRS
Newclip Technics
Orthopedic · 53d
Cleared Jan 15, 2018
Elos Accurate Customized Abutment, Elos Prosthetic Screw
K171799 · NHA
Elos Medtech Pinol A/S
Dental · 213d
Cleared CT Jan 13, 2018
MR4 Laser
K171354 · NHN
Multi Radiance Medical
Physical Medicine · 249d
Cleared Jan 12, 2018
Action Trackstander models TR1816, TR1820, TR2016, and TR2020
K163451 · IPL
Action Manufacturing, Inc.
Physical Medicine · 400d
Cleared Jan 12, 2018
Aleo BME Liquid Bandage
K171148 · KMF
Aleo Bme, Inc.
General & Plastic Surgery · 268d
Cleared Jan 12, 2018
One Touch Condom with Benzocaine
K171213 · HIS
Thai Nippon Rubber Industry Public...
Obstetrics & Gynecology · 262d
Cleared Jan 12, 2018
A7 Anesthesia System
K171292 · BSZ
Shenzhen Mindray Bio-Medical...
Anesthesiology · 255d
Cleared Jan 12, 2018
A5 Anesthesia System
K171311 · BSZ
Shenzhen Mindray Bio-Medical...
Anesthesiology · 255d
Cleared Jan 12, 2018
IRRIS (Infra-Red-Red Intubation System)
K171411 · BTR
A.R Guide IN Medical , Ltd.
Anesthesiology · 242d
Cleared Jan 12, 2018
MSD CRP Assay Kit and MESO SECTOR S 700 Instrument
K171498 · DCN
Meso Scale Diagnostics, LLC
Immunology · 234d
Cleared Jan 12, 2018
Single Lumen Ovum Aspiration Needles
K171625 · MQE
Willian A. Cook Australia Pty, Ltd.
Obstetrics & Gynecology · 224d
Cleared Jan 12, 2018
HBS2 Headless Bone Screw
K171628 · HWC
Stuckenbrock Medizintechnik GmbH
Orthopedic · 224d
Cleared Jan 12, 2018
PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE
K171958 · DZI
Mectron S.P.A.
Dental · 197d
Cleared Jan 12, 2018
ipsogen JAK2 RGQ PCR Kit
K172287 · PSU
Qiagen, Inc.
Pathology · 168d
Cleared Jan 12, 2018
ARBOR External Fixation System
K172438 · KTT
Globus Medical, Inc.
Orthopedic · 154d
Cleared Jan 12, 2018
Wiltrom Spinal Fixation System
K172548 · NKB
Wiltrom Corporation Limited
Orthopedic · 142d