Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
42481–42504 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 19, 2012
IND ONE STEP OCCULT BLOOD (FOB) TEST
K113506 · KHE
Ind Diagnostics, Inc.
Hematology · 387d
Cleared Dec 19, 2012
HELIO
K120628 · IOR
Motion Composites
Physical Medicine · 293d
Cleared Dec 19, 2012
KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING
K120985 · BTR
Kimberly-Clark Corp.
Anesthesiology · 261d
Cleared Dec 19, 2012
NEURODYN RUBY MUSCLE STIMULATOR, NEURODYN AUSSIE MUSCLE STIMULATOR
K121369 · GZJ
Ibramed Equipamentos Medicos
Neurology · 226d
Cleared Dec 19, 2012
INTRAVASCULAR ADMINISTRATION SET
K121803 · FPA
Acta Medical, LLC
General Hospital · 183d
Cleared Dec 19, 2012
CERTUS 140 2.45GHZ ABLATION SYSTEM
K122217 · NEY
Neuwave Medical, Inc.
General & Plastic Surgery · 147d
Cleared Dec 19, 2012
BASIXCONPAK ANALOG INFLATION SYRINGE
K122321 · MAV
Merit Medical Ireland, Ltd.
Cardiovascular · 140d
Cleared Dec 19, 2012
PMT TRUSCAN SURFACE ELECTRODE
K122376 · GXY
Pmt Corp.
Neurology · 135d
Cleared Dec 19, 2012
ONTEX AND OTHER PROPRIETARY NAMES
K122603 · HEB
Ontex Bvba
Obstetrics & Gynecology · 114d
Cleared Dec 19, 2012
MOBICATH TRANSSEPTAL NEEDLE
K122832 · DRC
Great Batch Medical
Cardiovascular · 93d
Cleared Dec 19, 2012
CINCHER-2.6 SUTURE ANCHOR MODEL FG-001
K122954 · MBI
Foundry Newcoxi, Inc.
Orthopedic · 85d
Cleared Dec 19, 2012
FINN CHAMBERS AQUA
K123184 · KXF
Smartpractice
General Hospital · 70d
Cleared Dec 19, 2012
OVS1 VIDEO SYSTEM
K123359 · FCW
Olive Medical Corp.
Gastroenterology & Urology · 49d
Cleared Dec 18, 2012
EVOLUTION 3E VENTILATOR
K113743 · CBK
Event Medical, Inc.
Anesthesiology · 364d
Cleared Dec 18, 2012
NUTRISAFE 2 FEEDING TUBE
K121105 · FPD
Vygon Corp.
Gastroenterology & Urology · 250d
Cleared Dec 18, 2012
HERMES MEDICAL IMAGING SUITE V5.2
K121278 · KPS
Hermes Medical Solutions AB
Radiology · 232d
Cleared Dec 18, 2012
AESCULAP NOVOSYN ABSORBABLE SUTURE
K122734 · GAM
Aesculap, Inc.
General & Plastic Surgery · 103d
Cleared Dec 18, 2012
UPSYLON Y MESH
K122794 · OTO
Boston Scientific Corp
Obstetrics & Gynecology · 97d
Cleared Dec 18, 2012
HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM
K122813 · DWC
Cincinnati Sub-Zero Products, Inc.
Cardiovascular · 96d
Cleared Dec 18, 2012
ORICARE L2700
K122875 · FSY
Oricare, Inc.
General & Plastic Surgery · 90d
Cleared Dec 18, 2012
NOVASILK MESH QTY 1 MODEL 93-6014, NOVASILK MESH QTY 3 MODEL 93-6015
K122968 · OTO
Coloplast Corp.
Obstetrics & Gynecology · 84d
Cleared Dec 18, 2012
IDRIVE ULTRA POWERED HANDLE AND ENDO GIA ADAPTER
K123318 · GDW
Covidien, Formerly US Surgical A...
General & Plastic Surgery · 54d
Cleared Dec 18, 2012
DR. SCHOLL'S COMPRESSION SOCKS
K123398 · DWL
Renfro Corporation
General Hospital · 43d
Cleared Dec 18, 2012
ELVAREX/ELVAREX SOFT/ELVAREX SOFT SEAMLESS
K123561 · DWL
Bsn Medical, Inc.
General Hospital · 29d