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
16681–16704 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 27, 2021
Rist 071 Radial Access Guide Catheter
K211990 · DQY
Micro Therapeutics, Inc. d/b/a ev3...
Neurology · 29d
Cleared Jul 27, 2021
ClariCT.AI
K212074 · LLZ
Claripi, Inc.
Radiology · 25d
Cleared Jul 26, 2021
OncoMate MSI Dx Analysis System
K200129 · PZJ
Promega Corporation
Pathology · 552d
Cleared Jul 26, 2021
Pac-Dent Ceramic Nanohybrid Resin
K210412 · EBF
Pac-Dent, Inc.
Dental · 165d
Cleared Jul 26, 2021
AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE
K210477 · OCL
AtriCure, Inc.
Cardiovascular · 157d
Cleared Jul 26, 2021
Vision Monitor - MonpackONE
K211643 · GWE
Metrovision
Ophthalmic · 60d
Cleared Jul 25, 2021
MASC Surgical Mask
K211984 · FXX
Mid-America Safety Corp.
General Hospital · 30d
Cleared Jul 24, 2021
Disposable Vinyl Nitrile Synthetic Gloves Powder Free
K211262 · LYZ
Tangshan Hongyun Healthcare Products...
General Hospital · 89d
Cleared Jul 24, 2021
Medical Face Mask
K211363 · FXX
Hubei Kangning Protective Products...
General Hospital · 82d
Cleared Jul 23, 2021
HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)
K201160 · ESW
M.I. Tech Co., Ltd.
Gastroenterology & Urology · 449d
Cleared Jul 23, 2021
Disposable Microwave Therapeutic Antennas
K201265 · NEY
Nanjing Eco Microwave System Co., Ltd.
General & Plastic Surgery · 438d
Cleared Jul 23, 2021
VS Newborn Heart Rate Monitor
K201887 · DQA
Surepulse Medical Limited
Cardiovascular · 380d
Cleared Jul 23, 2021
Disposable IV catheter
K202060 · FOZ
Shinva Ande Healthcare Apparatus Co.,...
General Hospital · 361d
Cleared Jul 23, 2021
Infrared Forehead Thermometer, Model BSX976
K202296 · FLL
Shenzhen Bsx Technology Electronics...
General Hospital · 344d
Cleared Jul 23, 2021
Sensititre 20-24 hour Haemophilus influenzae /Streptococcus pneumoniae MIC or...
K202612 · JWY
Thermo Fisher Scientific
Microbiology · 317d
Cleared Jul 23, 2021
Peregrine Endoscopy System
K202727 · EOB
3nt Medical , Ltd.
Ear, Nose, Throat · 309d
Cleared Jul 23, 2021
IntraLock System
K210159 · HWC
Fusion Orthopedics, LLC
Orthopedic · 183d
Cleared Jul 23, 2021
CardioCurve Steerable Sheath
K210185 · DYB
Talon Surgical
Cardiovascular · 179d
Cleared Jul 23, 2021
Home Use IPL Beauty Device, Model(s): MS-208B, MS-212B, MS-216B, MS-218B,...
K210311 · OHT
Shenzhen Mismon Technology Co., Ltd.
General & Plastic Surgery · 170d
Cleared Jul 23, 2021
Blustone Synergy Diamond SA Cervical System
K210382 · OVE
Blustone Synergy, LLC
Orthopedic · 164d
Cleared Jul 23, 2021
SC1 Handheld Ultrasound Imaging System (Model: SC1)
K210468 · IYO
Fcu Co., Ltd.
Radiology · 157d
Cleared Jul 23, 2021
IS Multi Unit Abutment System
K210903 · NHA
Neobiotech Co., Ltd.
Dental · 119d
Cleared Jul 23, 2021
Nitrile Patient Examination Gloves
K211012 · LZA
Huayuan Medical Technology(Shangqiu)...
General Hospital · 109d
Cleared Jul 23, 2021
Altor Safety 3-Ply Surgical Mask (Model:62222)
K211249 · FXX
Altor Safety, LLC
General Hospital · 88d