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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
73873–73896 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 13, 2003
MEDS-3 NEUROMUSCULAR STIMULATOR
K023443 · GZJ
Medical Equipment Device Specialists
Neurology · 90d
Cleared Jan 13, 2003
MEDS-3 NEUROMUSCULAR STIMULATOR
K023446 · IPF
Medical Equipment Device Specialists
Physical Medicine · 90d
Cleared Jan 13, 2003
NON-INVASIVE PATIENT FIXATION SYSTEM
K023449 · IYE
Stryker Leibinger
Radiology · 90d
Cleared Jan 13, 2003
DATEX-OHMEDA S/5 ENTROPY MODULE, M-ENTROPY AND ACCESSORIES
K023459 · OLW
Datex-Ohmeda
Neurology · 90d
Cleared Jan 13, 2003
IMPULSE-ADJUSTING INSTRUMENT, CBP ADJUSTING INSTRUMENT, NEUROMECHANICAL...
K023462 · LXM
Neuromechanical Innovations, LLC
Physical Medicine · 90d
Cleared Jan 13, 2003
VIRIDIS TWIN OPHTHALMIC PHOTOCOAGULATOR
K023464 · GEX
Quantel Medical
General & Plastic Surgery · 90d
Cleared Jan 13, 2003
GOLD CORE PLUS
K023499 · EJH
Pentron Laboratory Technologies
Dental · 87d
Cleared Jan 13, 2003
LOMA LINDA UNIVERSITY MEDICAL CENTER (LLUMC) CRANIAL REMOLDING HELMET
K023572 · MVA
Rehabilitation Institute,Loma Linda...
Neurology · 81d
Cleared Jan 13, 2003
RANDOX FRUCTOSAMINE, FRUCTOSAMINE CALIBRATOR, FRUCTOSAMINE CONTROLS
K023763 · LCP
Randox Laboratories, Ltd.
Chemistry · 66d
Cleared Jan 13, 2003
LIQUICHEK ANTI-RNP CONTROL, POSITIVE, CATALOG #116
K024223 · LKJ
Bio-Rad
Immunology · 21d
Cleared Jan 13, 2003
LIQUICHEK ANTI-MITOTIC SPINDLE PATTERN CONTROL, POSITIVE, CATALOG #118
K024231 · DHN
Bio-Rad
Immunology · 21d
Cleared Jan 13, 2003
CHEMO DISPENSING PIN, MODEL 12495
K024239 · LHI
Abbott Laboratories
General Hospital · 21d
Cleared Jan 10, 2003
LIMERICK POWERED ELECTRIC BREAST PUMP MODEL 1002
K021739 · HGX
Limerick, Inc.
Obstetrics & Gynecology · 227d
Cleared Jan 10, 2003
SOLA, COUNTER-PULSATION, MODEL SECP-S
K022078 · DRN
Sola Medical Devices, LLC
Cardiovascular · 198d
Cleared Jan 10, 2003
MEDRAD STELLANT CT INJECTOR SYSTEM
K023183 · DXT
Medrad, Inc.
Cardiovascular · 108d
Cleared Jan 10, 2003
BONART ART-L2 LIGHT CURING UNIT
K023721 · EBZ
Bonart Co., Ltd.
Dental · 66d
Cleared Jan 10, 2003
NUSOFT SPHERICAL, TORIC, ASPHERIC AND BIFOCAL (OCUFILCON B) SOFT CONTACT...
K023791 · LPL
Softfocal Company, Inc.
Ophthalmic · 58d
Cleared Jan 10, 2003
GREEN POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES WITH PEPPERMINT FLAVOR
K024083 · LZA
Supermax Glove Manufacturing Sdn Bhd
General Hospital · 30d
Cleared Jan 10, 2003
A-SCAN 100
K024114 · IYO
Ophthalmic Technologies, Inc.
Radiology · 28d
Cleared Jan 10, 2003
DUAL-LUMEN CATHETER
K024165 · EOQ
Bistech, Inc.
Ear, Nose, Throat · 24d
Cleared Jan 10, 2003
LIQUICHEK ANTI-SCL-70 CONTROL, POSITIVE, CATALOG #116
K024226 · LKJ
Bio-Rad
Immunology · 18d
Cleared Jan 09, 2003
JOSTRA SINGLE STAGE VENOUS RETURN CATHETERS
K020784 · DWF
Jostra AG
Cardiovascular · 304d
Cleared Jan 09, 2003
CARTO XP AND QWIKMAP EP NAVIGATION SYSTEM
K020863 · DQK
Biosense Webster, Inc.
Cardiovascular · 297d
Cleared Jan 09, 2003
KING LT, MODELS # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105
K021634 · CAE
King Systems Corp.
Anesthesiology · 237d