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
41425–41448 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 25, 2013
VARIANT II HEMOGLOBIN A1C PROGRAM (NEW), VARIANT II HEMOGLOBIN TESTING SYSTEM...
K130860 · LCP
Bio-Rad Laboratories, Inc., Clinical...
Chemistry · 28d
Cleared Apr 25, 2013
GLOOKO DEVICE SYSTEM FOR GLOOKO LOGBOOK+ APPLICATION
K130886 · NBW
Glooko, Inc.
Chemistry · 27d
Cleared Apr 24, 2013
TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRIX PROFESSIONAL...
K120989 · NBW
Nipro Diagnostics, Inc.
Chemistry · 387d
Cleared Apr 24, 2013
PREVIEW FORWARD-LOOKING IVUS CATHETER AND LAPTOP SYSTEM
K122826 · DQY
Volcano Corporation
Cardiovascular · 222d
Cleared Apr 24, 2013
RHYTHM VIEW
K123295 · DQK
Topera, Inc.
Cardiovascular · 184d
Cleared Apr 24, 2013
BIOMODULE 3-M1
K123658 · DRX
Zephyr Technology Corporation
Cardiovascular · 147d
Cleared Apr 24, 2013
DE48-PLUS
K123915 · GXY
Grass Technologies, an Astro-Med,...
Neurology · 126d
Cleared Apr 24, 2013
SURGISEAL TOPICAL SKIN ADHESIVE
K123936 · MPN
Adhezion Biomedical, LLC
General & Plastic Surgery · 125d
Cleared Apr 24, 2013
VASCULAR PROBE, VASCULAR PROBE ES
K130896 · DWP
Synovis Life Technologies, Inc.
Cardiovascular · 23d
Cleared Apr 23, 2013
NXSTAGE SYSTEM ONE
K122051 · KDI
Nxstage Medical, Inc.
Gastroenterology & Urology · 285d
Cleared Apr 23, 2013
ENCIRCLE COMPRESSION THERAPY STOCKING
K122485 · DWL
Encircle Medical Devices , Ltd.
General Hospital · 252d
Cleared Apr 23, 2013
ACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, ACE ION SELECTIVE...
K123018 · CFR
Alfa Wassermann Diagnostic...
Chemistry · 207d
Cleared Apr 23, 2013
NUVASIVE NVM5 SYSTEM
K123307 · PDQ
Nuvasive, Inc.
Neurology · 181d
Cleared Apr 23, 2013
AQUAMAX (POLYMACON) DISPOSABLE SOFT (HYDROPHILIC) CONTACT LENSES
K123973 · LPL
Pegavision Corporation
Ophthalmic · 118d
Cleared Apr 23, 2013
PASSEO-35
K130161 · LIT
Biotronik, Inc.
Cardiovascular · 90d
Cleared Apr 23, 2013
MAYFIELD INFINITY XR2 SKULL CLAMP
K130389 · HBL
Integra LifeSciences Corporation
Neurology · 67d
Cleared Apr 23, 2013
ACCELEDENT AURA
K130643 · OYH
Orthoaccel Technologies, Inc.
Dental · 43d
Cleared Apr 23, 2013
ERCHONIA PL5000
K130741 · NHN
Erchonia Medical, Inc.
Physical Medicine · 35d
Cleared Apr 22, 2013
XHIBIT CENTRAL STATION, MODEL 96102
K122146 · MHX
Spacelabs Healthcare
Cardiovascular · 277d
Cleared Apr 22, 2013
NEXXIS OR
K122167 · DXJ
Barco N.V.
Cardiovascular · 273d
Cleared Apr 22, 2013
NEXFIN MODEL 2
K122381 · DXN
Edwards Lifesciences, LLC
Cardiovascular · 259d
Cleared Apr 22, 2013
STAYHEALTHY HEALTH KIOSK, STAYHEALTHY HEALTHCENTER KIOSK
K123539 · DXN
Stayhealthy, Inc.
Cardiovascular · 157d
Cleared Apr 22, 2013
NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM (WITH PAXSCAN 4343CB)
K130318 · JAA
Varian Medical Systems, X-Ray...
Radiology · 73d
Cleared Apr 22, 2013
AAP CANNULATED SCREW 2.0
K130590 · HWC
Aap Implantate AG
Orthopedic · 46d