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
70009–70032 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 25, 2004
AUTOQUANT PLUS
K040326 · KPS
Adac Laboratories
Radiology · 15d
Cleared Feb 24, 2004
CREATION NM DIAGNOSTIC CATHETERS
K032888 · DQO
Neich Medical (Shenzhen) Company Limited
Cardiovascular · 161d
Cleared Feb 24, 2004
CALYSTO SERIES IV PATIENT CARE MONITORS AND CENTRAL STATION AND ECG...
K033030 · MWI
Witt Biomedical Corp
Cardiovascular · 151d
Cleared Feb 24, 2004
POWDER FREE LATEX SURGEONS GLOVES POLYMER COATED STERILE WITH OPTIONAL...
K033564 · KGO
Kanam Latex Industries Pvt. , Ltd.
General Hospital · 104d
Cleared Feb 24, 2004
ACUNAV 90/10 DIAGNOSTIC ULTRASOUND CATHETER
K033650 · OBJ
Siemens Medical Solutions USA, Inc.
Radiology · 96d
Cleared Feb 24, 2004
DISPOSABLE POWDERED VINYL PATIENT EXAMINATION GLOVES
K033723 · LYZ
Baoding Guanzhong Glove Co., Ltd.
General Hospital · 90d
Cleared Feb 24, 2004
DUAL TOP ANCHOR SYSTEM SCREWS
K033767 · DZE
Jeil Medical Corporation
Dental · 83d
Cleared Feb 24, 2004
HERMES
K033996 · EBF
3M Espe AG Dental Products
Dental · 62d
Cleared Feb 24, 2004
MAXTER POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES
K040176 · LZA
Maxter Glove Manufacturing Sdn Bhd
General Hospital · 29d
Cleared Feb 24, 2004
COBRA SURGICAL PROBE
K040219 · GEI
Boston Scientific Corp
General & Plastic Surgery · 22d
Cleared Feb 24, 2004
SKINTACT ECG ELECTRODE
K040249 · DRX
Leonhard Lang GmbH
Cardiovascular · 21d
Cleared Feb 24, 2004
VITREA2 VERSION 3.5
K040305 · LLZ
Vital Images, Inc.
Radiology · 15d
Cleared Feb 24, 2004
DIGITAL BLOOD PRESSURE MONITOR, MODEL DS-1862
K040309 · DXN
Nihon Seimitsu Sokki Co., Ltd.
Cardiovascular · 15d
Cleared Feb 23, 2004
SPECTRANETICS QUICK CROSS CATHETERS, MODELS 518-032, 518-033, 518034,...
K033678 · DQY
Spectranetics Corp.
Cardiovascular · 91d
Cleared Feb 23, 2004
NOBEL BIOCARE CENTRIC POST, MODELS 31234, 31235 AND 31236
K033724 · NHA
Nobel Biocare Uas, Inc.
Dental · 89d
Cleared Feb 23, 2004
TITANIUM CANNULATED INTERFERENCE SCREW
K033749 · HWC
Advanced Biomaterials
Orthopedic · 84d
Cleared Feb 23, 2004
SIROAIR L AIR SCALER
K033812 · EFB
Sirona Dental Systems GmbH
Dental · 76d
Cleared Feb 23, 2004
MICROLIFE DIGITAL INFRARED FOREHEAD THERMOMETER, MODEL FR1DM1
K033820 · FLL
Microlife Intellectual Property GmbH
General Hospital · 76d
Cleared Feb 23, 2004
LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS
K040091 · JJY
Cliniqa Corporation
Chemistry · 38d
Cleared Feb 23, 2004
DEPUY SIGMA XLK TIBIAL INSERTS
K040166 · JWH
DePuy Orthopaedics, Inc.
Orthopedic · 28d
Cleared Feb 23, 2004
SYNTHES (USA) CRANIOFACIAL PLATES
K040272 · JEY
Synthes (Usa)
Dental · 18d
Cleared Feb 20, 2004
SMARTEP-ASSR, MODEL M811007
K031051 · GWJ
Intelligent Hearing Systems
Neurology · 324d
Cleared Feb 20, 2004
HORIZON (METHAFILCON A) DAILY WEAR SPHERE AND TORIC CONTACT LENSES
K031774 · LPL
Westcon Contact Lens Co., Inc.
Ophthalmic · 256d
Cleared Feb 20, 2004
BILEVEL CPAP, MODEL 9055 SERIES
K032056 · BZD
Sunrise Medical
Anesthesiology · 233d