FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
24721–24744 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 27, 2018
Stowe Pedicle Screw System
K181554 · NKB
Black Box Medical
Orthopedic · 44d
Cleared Jul 27, 2018
FlowTriever Retrieval/Aspiration System
K181694 · QEW
Inari Medical
Cardiovascular · 30d
Cleared Jul 27, 2018
FUJIFILM Ultrasonic Endoscope
K181763 · FDS
Fujifilm Corporation
Gastroenterology & Urology · 24d
Cleared Jul 26, 2018
Vios Central Station Monitor Software, Vios Central Server Software
K173107 · DXJ
Vios Medical, Inc.
Cardiovascular · 300d
Cleared Jul 26, 2018
Arthrex FibuLock Nail
K173656 · HSB
Arthrex, Inc.
Orthopedic · 239d
Cleared Jul 26, 2018
Saniclave 250
K180272 · FLE
Revolutionary Science
General Hospital · 176d
Cleared Jul 26, 2018
Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter,...
K180958 · PPN
Shockwave Medical, Inc.
Cardiovascular · 105d
Cleared Jul 26, 2018
PROLENE (Polypropylene) 3D Patch
K181268 · FTL
Ethicon, Inc.
General & Plastic Surgery · 73d
Cleared Jul 26, 2018
RxSight Insertion Device
K181401 · MSS
Rxsight, Inc.
Ophthalmic · 58d
Cleared Jul 26, 2018
eLens Rigid Gas Permeable Contact Lens for Daily Wear, eLens Rigid Gas...
K181579 · HQD
E&E Optics, Inc.
Ophthalmic · 41d
Cleared Jul 26, 2018
Avologi ENEO
K181659 · OHS
Premier North America, Inc.
General & Plastic Surgery · 31d
Cleared Jul 26, 2018
Level 1 Convective Warmer
K181699 · DWJ
Smiths Medical Asd, Inc.
Cardiovascular · 29d
Cleared Jul 26, 2018
neuromate Gen III
K181706 · HAW
Renishaw Mayfield Sarl
Neurology · 28d
Cleared Jul 26, 2018
San Antonio Stopcock
K181712 · ODC
Cook Incorporated
Gastroenterology & Urology · 28d
Cleared Jul 26, 2018
CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup
K181790 · NGL
Hangzhou Clongene Biotech Co., Ltd.
Toxicology · 21d
Cleared Jul 26, 2018
RadialSeal Introducer Kit
K181855 · DYB
Great Batch Medical
Cardiovascular · 15d
Cleared Jul 25, 2018
RHYTHMIA HDx Mapping System (with software Version 2.0)
K173837 · DQK
Boston Scientific Corporation
Cardiovascular · 219d
Cleared Jul 25, 2018
Lumbar Interbody Fusion System (OLLIF)
K173947 · MAX
Advanced Research Medical, LLC
Orthopedic · 210d
Cleared Jul 25, 2018
TREND II Spinal Fixation System- STEP Series
K180226 · NKB
Paonan Biotech Co., Ltd.
Orthopedic · 180d
Cleared Jul 25, 2018
Smartinhaler
K180407 · CAF
Adherium (Nz), Ltd.
Anesthesiology · 161d
Cleared Jul 25, 2018
Exactech Equinoxe Small Reverse Shoulder System
K180632 · PHX
Exactech, Inc.
Orthopedic · 135d
Cleared Jul 25, 2018
Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit,...
K180752 · HIH
Corinth Medtech, Inc.
Obstetrics & Gynecology · 125d
Cleared Jul 25, 2018
FIXIT / ComposiTCP Threaded Anchor System
K180960 · MAI
S.B.M. Sas Sciences For Bio Materials
Orthopedic · 104d
Cleared Jul 25, 2018
ATEC ALIF Spacer System
K181453 · MAX
Alphatec Spine, Inc.
Orthopedic · 54d