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
20185–20208 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 28, 2020
VITEK 2 AST-Gram Positive Delafloxacin (<=0.015 - >=1 µg/mL)
K200590 · LON
bioMerieux, Inc.
Microbiology · 53d
Cleared Apr 28, 2020
Affixus(R) Natural Nail(R) System Humeral Nail
K200814 · HSB
Zimmer GmbH
Orthopedic · 29d
Cleared Apr 28, 2020
Tiger® Occipital-Cervical-Thoracic Spinal Fixation System
K200863 · NKG
Corelink, LLC
Orthopedic · 27d
Cleared Apr 28, 2020
Implantswiss Dental Implant System and Implantswiss Dental Abutment System
K200867 · DZE
Novodent SA
Dental · 27d
Cleared Apr 28, 2020
Solstice CCI
K200896 · NKG
Life Spine, Inc.
Orthopedic · 25d
Cleared Apr 27, 2020
Leadtek Fingertip Pulse Oximeter
K193350 · DQA
Leadtek Research, Inc.
Anesthesiology · 146d
Cleared Apr 27, 2020
GlassLok Kits, GlassLok Powder, GlassLok Liquid
K193388 · DYH
Reliance Orthodontic Products, Inc.
Dental · 143d
Cleared Apr 27, 2020
Panther Stereotactic
K193459 · MUJ
Prowess, Inc.
Radiology · 133d
Cleared Apr 27, 2020
WOLF Thrombectomy V System
K200101 · QEW
Devoro Medical, Inc.
Cardiovascular · 101d
Cleared Apr 27, 2020
Oxi-W System
K200141 · MWI
Ld Technology, LLC
Anesthesiology · 97d
Cleared Apr 27, 2020
Agape Warming Personal Lubricant
K200208 · NUC
CC Wellness, LLC
Obstetrics & Gynecology · 90d
Cleared Apr 27, 2020
Mydriatic Hyperspectral Retinal Camera (MHRC-C1)
K200254 · HKI
Optina Diagnostics
Ophthalmic · 84d
Cleared CT Apr 27, 2020
binx io CT/NG Assay and binx io CT/NG System
K200533 · QEP
Binx Health, Inc.
Microbiology · 56d
Cleared Apr 27, 2020
Capnostream 35 Portable Respiratory Monitor
K200594 · CCK
Oridion Medical 1987 , Ltd.
Anesthesiology · 52d
Cleared Apr 27, 2020
Percutaneous Introducer
K200624 · BSO
Epimed International, Inc.
Anesthesiology · 48d
Cleared Apr 26, 2020
MECTA Sigma
K192834 · QGH
Mecta Corporation
Neurology · 207d
Cleared Apr 26, 2020
ControlRad Sterile Cover
K200238 · KKX
Controlrad, Inc.
General Hospital · 86d
Cleared Apr 25, 2020
i-ED COIL
K192068 · HCG
Kaneka Pharma America, LLC
Neurology · 268d
Cleared Apr 25, 2020
Gatekeeper Balloon Catheter
K192786 · MJN
Arch Catheter, LLC
Cardiovascular · 208d
Cleared Apr 25, 2020
PROFEMUR GLADIATOR Thin HA Classic Hip Stem with Collar
K200007 · LZO
Microport Orthopedics, Inc.
Orthopedic · 114d
Cleared Apr 25, 2020
Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with...
K200581 · LZA
Hartalega NGC Sdn. Bhd.
General Hospital · 51d
Cleared Apr 24, 2020
Zircos-Com
K190139 · EBF
Bioden Co., Ltd.
Dental · 451d
Cleared Apr 24, 2020
Maxxi Position Sensor
K191492 · GWQ
Neurovirtual USA, Inc.
Neurology · 324d
Cleared Apr 24, 2020
Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate
K192017 · KPO
Fresenius Medical Care Renal...
Gastroenterology & Urology · 270d