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
18457–18480 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 09, 2020
Disposable Surgical Mask
K201893 · FXX
Xiamen Probtain Medical Techology...
General Hospital · 154d
Cleared Dec 09, 2020
V30 system, V20 system, V10 system, V-VR Hand piece
K202247 · PBX
Viora , Ltd.
General & Plastic Surgery · 121d
Cleared Dec 09, 2020
ClearPetra Suction-Evacuation Sheath
K203119 · FED
Well Lead Medical Co., Ltd.
Gastroenterology & Urology · 54d
Cleared Dec 09, 2020
Cystoject Syringe Lever
K203321 · QBL
Urogen Pharma, Ltd.
Gastroenterology & Urology · 27d
Cleared Dec 08, 2020
Taperloc® Complete Hip Stems
K200196 · LZO
Biomet Orthopedics
Orthopedic · 316d
Cleared Dec 08, 2020
Accu-Joint Hemi Implant
K200951 · KWD
Accufix Surgical, Inc.
Orthopedic · 243d
Cleared Dec 08, 2020
Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator,...
K201253 · KTT
Smith & Nephew
Orthopedic · 211d
Cleared Dec 08, 2020
CARES Screw - Retained Bars and Bridges (SRBB)
K201711 · NHA
Medentika GmbH
Dental · 168d
Cleared Dec 08, 2020
Biomonitor III, Biomonitor IIIm
K201865 · MXD
Biotronik, Inc.
Cardiovascular · 155d
Cleared Dec 08, 2020
Graffiti
K202189 · DQK
Ge Medical Systems Information...
Cardiovascular · 126d
Cleared Dec 08, 2020
Novapak Nasal Sinus Packing and Stent
K202623 · LYA
Medtronic Xomed
Ear, Nose, Throat · 89d
Cleared Dec 08, 2020
iHelmet Laser Comb
K202631 · OAP
Slinph Technologies Co., Ltd.
General & Plastic Surgery · 88d
Cleared Dec 08, 2020
Biofeedback Nerve and Muscle Stimulator
K202648 · IPF
Shenzhen Konmed Technology Co., Ltd.
Physical Medicine · 88d
Cleared Dec 08, 2020
Evis Exera III Duodenovideoscope Olympus TJF-Q190V
K202661 · FDT
Olympus Medical Systems Corp.
General Hospital · 85d
Cleared Dec 08, 2020
easy Hairfull
K202983 · OAP
Y & J Bio Co., Ltd.
General & Plastic Surgery · 69d
Cleared Dec 08, 2020
CD Horizon Spinal System Instruments
K203291 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 29d
Cleared Dec 07, 2020
HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens
K200618 · LPL
Visco Vision, Inc.
Ophthalmic · 273d
Cleared Dec 07, 2020
B-Secur HeartKey Software Library
K200884 · DPS
B-Secur , Ltd.
Cardiovascular · 249d
Cleared Dec 07, 2020
Callaly Tampliner
K201003 · HEB
Calla Lily Personal Care, Ltd.
Obstetrics & Gynecology · 235d
Cleared Dec 07, 2020
HepaFat-AI
K201039 · LNH
Resonance Health Analysis Services...
Radiology · 231d
Cleared Dec 07, 2020
Vortex Radial Spray Catheter
K201183 · GEH
CSA Medical, Inc.
General & Plastic Surgery · 220d
Cleared Dec 07, 2020
Pulse Oximeter
K201384 · DQA
Shenzhen Raysintone Technology Co., Ltd.
Anesthesiology · 195d
Cleared Dec 07, 2020
YUWELL Infrared Thermometer
K201864 · FLL
Jiangsu Yuyue Medical Equipment&...
General Hospital · 154d
Cleared Dec 07, 2020
Pulse Oximeter
K202173 · DQA
Shenzhen AOJ Medical Technology Co.,...
Anesthesiology · 126d