FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
68665–68688 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Feb 20, 2004
THEKEN CPOD/LPOD VERTEBRAL BODY REPLACEMENT SYSTEM
K032064 · MQP
Theken Surgical,Llc
Orthopedic · 232d
Cleared Feb 20, 2004
INFRARED SCIENCES BREASTSCAN IR SYSTEM
K032350 · LHQ
Infrared Sciences Corp.
Radiology · 205d
Cleared Feb 20, 2004
STRYKER SPINE OASYS SYSTEM
K032394 · MNI
Howmedica Osteonics Corp.
Orthopedic · 200d
Cleared Feb 20, 2004
DIGITAL ANGIOGRAPHY SYSTEM DIGITEX SAFIRE
K032443 · IZI
Shimadzu Corp.
Radiology · 196d
Cleared Feb 20, 2004
PHILIPS SPO2 REUSABLE SENSORS, MODEL NOS. M1191T, M1192T, AND M1193T
K032979 · DQA
Philips Medical Systems, Inc.
Anesthesiology · 149d
Cleared Feb 20, 2004
COLOR LCD DISPLAY, MODEL RADIFORCE R22
K033466 · LLZ
Eizo Nanao Corporation
Radiology · 112d
Cleared Feb 20, 2004
PALINDROME 14.5 FR CHRONIC HEMODIALYSIS CATHETER
K033676 · MSD
Kendall
Gastroenterology & Urology · 88d
Cleared Feb 20, 2004
BRAIN PERFUSION OPTION
K033677 · JAK
Philips Medical Systems (Cleveland),...
Radiology · 88d