FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
14233–14256 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 21, 2021
CardiaMend Pericardial and Epicardial Reconstruction Matrix
K210331 · PSQ
Helios Cardio, Inc.
Cardiovascular · 319d
Cleared Dec 21, 2021
BU-CAD
K210670 · QDQ
Taihao Medical, Inc.
Radiology · 291d
Cleared Dec 21, 2021
reVive Light Therapy Essentials
K210968 · OLP
Led Technologies, Inc.
General & Plastic Surgery · 265d
Cleared Dec 21, 2021
Progreat Lambda
K211078 · DQO
Terumo Clinical Supply Co., Ltd.
Cardiovascular · 253d
Cleared Dec 21, 2021
The Progen™ Trochanteric Nail System
K211086 · HSB
Ortho Development Corporation
Orthopedic · 253d
Cleared Dec 21, 2021
N1 TiUltra TCC Implant System
K211109 · DZE
Nobel Biocare Services AG
Dental · 251d
Cleared Dec 21, 2021
iCOquit® Smokerlyzer®
K211918 · CCJ
Bedfont Scientific, Ltd.
Toxicology · 183d
Cleared Dec 21, 2021
TheraFace LED
K212155 · OHS
Theragun, Inc.
General & Plastic Surgery · 162d
Cleared Dec 21, 2021
FIX-C PEEK Anterior Cervical Interbody System
K212266 · ODP
Jeil Medical Corporation
Orthopedic · 154d
Cleared Dec 21, 2021
Powder Free Nitrile Examination Gloves, Non-sterile,Tested For Use with...
K212613 · LZA
Koon Seng Sdn Bhd
General Hospital · 125d
Cleared Dec 21, 2021
qXR-BT
K212690 · QIH
Qure.Ai Technologies
Radiology · 118d
Cleared Dec 21, 2021
BellaTek Encode Emergence Healing Abutments
K212730 · NHA
Biomet 3i, LLC
Dental · 113d
Cleared Dec 21, 2021
Vision
K212770 · PNN
Softsmile, Inc.
Dental · 112d
Cleared Dec 21, 2021
CT3000Pro
K212830 · FEN
Srs Medical
Gastroenterology & Urology · 105d
Cleared Dec 21, 2021
Vinyl Examination Gloves
K213006 · LYZ
Taian Hengchang Medical Technology...
General Hospital · 92d
Cleared Dec 21, 2021
TearCare System
K213045 · ORZ
Sight Sciences, Inc.
Ophthalmic · 90d
Cleared Dec 21, 2021
Restoration Modular 115mm Conical Distal Stem
K213129 · LZO
Howmedica Osteonics Corp., Dba...
Orthopedic · 85d
Cleared Dec 21, 2021
SURGmatic S15 L Pro
K213139 · EGS
Kavo Dental GmbH
Dental · 85d
Cleared Dec 21, 2021
InCore Subtalar System
K213301 · HWC
Nextremity Solutions, Inc.
Orthopedic · 81d
Cleared Dec 21, 2021
Xenco Medical Multilevel CerviKit
K213456 · KWQ
Xenco Medical, LLC
Orthopedic · 56d
Cleared Dec 21, 2021
OSSIOfiber Compression Screw, 3.5mm
K213596 · HWC
OSSIO , Ltd.
Orthopedic · 39d
Cleared Dec 21, 2021
DRSplus
K213705 · MYC
Centervue S.P.A.
Ophthalmic · 27d
Cleared Dec 20, 2021
Mpact® 3D Metal Implants - DMLS Technology
K202568 · LPH
Medacta International S.A.
Orthopedic · 472d
Cleared Dec 20, 2021
TCAT TKA Instrument Tray
K203468 · KCT
THINK Surgical, Inc.
General Hospital · 390d