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
45961–45984 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 14, 2011
ARGES IMAGING CONTRAST SPRAY
K113263 · ELW
Arges Imaging, Inc.
Dental · 10d
Cleared Nov 14, 2011
IDENTIUM HEAVY, IDENTIUM MEDIUM, IDENTIUM SCAN HEAVY, IDENTIUM SCAN MEDIUM,...
K113279 · ELW
Kettenbach GmbH & Co. KG
Dental · 7d
Cleared Nov 10, 2011
NEXGEN EXPANDABLE CATHETER
K102925 · DYB
Nexgen Medical Systems, Inc.
Cardiovascular · 402d
Cleared Nov 10, 2011
BMR FACE
K103031 · NFO
Bio-Medical Research, Ltd.
Neurology · 394d
Cleared Nov 10, 2011
MULTIFUNCTION KEITO
K103058 · DXN
Aguiflai Iberica S.L.
Cardiovascular · 392d
Cleared Nov 10, 2011
PCECG-1200 SYSTEM WITH MODULAR ECG ANALYSIS SYSTEM (MEANS)
K110463 · MWI
Norav Medical , Ltd.
Cardiovascular · 266d
Cleared Nov 10, 2011
NH-301 AMBULATORY ECG ANALYSIS SOFTWARE
K111487 · MLO
Norav Medical Corp.
Cardiovascular · 163d
Cleared Nov 10, 2011
X-FORCE
K111557 · NYN
Seven Seas Distribtion and...
Neurology · 160d
Cleared Nov 10, 2011
KNOTLESS SUTURE FIXATION SYSTEM
K111716 · MBI
Core Essence Orthopaedics
Orthopedic · 143d
Cleared Nov 10, 2011
CHARTIS CONSOLE
K111764 · BZG
Pulmonx, Inc.
Anesthesiology · 140d
Cleared Nov 10, 2011
IGLUCOSE SYSTEM
K111932 · NBW
Positiveid Corporation
Chemistry · 125d
Cleared Nov 10, 2011
SPI VARIO ANGLED ABUTMENT
K111984 · NHA
Thommen Medical AG
Dental · 121d
Cleared Nov 10, 2011
CS 1200
K112321 · EIA
Carestream Health, Inc.
Dental · 90d
Cleared Nov 10, 2011
VESSEL GUARDIAN
K112357 · HIF
Lexion Medical, LLC
Obstetrics & Gynecology · 86d
Cleared Nov 10, 2011
XTRACT SYRINGE KEY SYSTEM
K112475 · FMF
Xtract Solutions
General Hospital · 73d
Cleared Nov 10, 2011
DIGITAL FLAT PANEL X-RAY DETECTOR
K112558 · MQB
Samsung Mobile Display Co., Ltd.
Radiology · 69d
Cleared Nov 10, 2011
VASOPRESS REPROCESSED DVT LEG / FOOT GARMENTS
K112838 · JOW
Compression Therapy Concepts, Inc.
Cardiovascular · 43d
Cleared Nov 10, 2011
PROFEMUR XM WINGLESS DISTAL CENTRALIZER, PERFECTA DISTAL CENTRALIZER
K113019 · KWA
Wrightmedicaltechnologyinc
Orthopedic · 30d
Cleared Nov 10, 2011
AMEDITECH IMMUTEST MILTI-DRUG SCREEN
K113046 · DKZ
Ameditech, Inc.
Toxicology · 28d
Cleared Nov 10, 2011
CT-GUIDE NEEDLE GUIDANCE SYSTEM
K113063 · JAK
Activiews, Ltd.
Radiology · 27d
Cleared Nov 09, 2011
STINGRAY ULTRALITE DISPOSABLE IRRIGATING BIPOLAR FORCEPS
K102752 · GEI
Stingray Surgical Products, Inc.
General & Plastic Surgery · 412d
Cleared Nov 09, 2011
SPIRO PD
K103575 · BZG
Pmd Healthcare
Anesthesiology · 338d
Cleared Nov 09, 2011
POWERPRESS UNIT
K110276 · JOW
Hanuri Distribution, Inc.
Cardiovascular · 282d
Cleared Nov 09, 2011
NANOVIS INTERVERTEBRAL BODY FUSION SYSTEM
K110442 · ODP
Nanovis, LLC
Orthopedic · 266d