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
50401–50424 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 19, 2010
JETSTREAM G3 L SYSTEM, PV CONSOLE, MODELS PV31400, PV31300, PVCN100
K100462 · MCW
Pathway Medical Technologies, Inc.
Cardiovascular · 90d
Cleared May 19, 2010
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K100856 · LYZ
Suzhou Shengyuda Plastic Products...
General Hospital · 54d
Cleared May 19, 2010
REGENT ANTERIOR CERVICAL PLATE
K101151 · KWQ
Custom Spine
Orthopedic · 26d
Cleared May 18, 2010
INTERSURGICAL HEATED WIRE BREATHING SYSTEMS AND HUMIDIFICATION CHAMBERS,...
K092129 · BZE
Intersurgical, Inc.
Anesthesiology · 307d
Cleared May 18, 2010
THYRETAIN TM TSI REPORTER BIOASSAY
K092229 · JZO
Diagnostic Hybrids, Inc.
Immunology · 299d
Cleared May 18, 2010
FEMEYE TWO
K093218 · HIH
Fem Suite, LLC
Obstetrics & Gynecology · 217d
Cleared May 18, 2010
KENSEY NASH ECM SURGICAL PATCH
K094061 · FTM
Kensey Nash Corporation
General & Plastic Surgery · 138d
Cleared May 18, 2010
CARDO MEDICAL CERAMIC HIP SYSTEM
K100008 · LZO
Cardo Medical, Inc.
Orthopedic · 134d
Cleared May 18, 2010
OTOMAG BONE CONDUCTION HEARING SYSTEM
K100193 · LXB
Sophono, Inc.
Ear, Nose, Throat · 116d
Cleared May 18, 2010
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K100734 · LYZ
Huanfu Plastic Products Limited
General Hospital · 64d
Cleared May 18, 2010
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K100735 · LYZ
Rayu Plastic Products Limited
General Hospital · 64d
Cleared May 18, 2010
TITAN TI SUTURE ANCHOR SYSTEM, MODELS 22-9055, 22-9055N, 22-9065, 22-9065N,...
K101184 · MBI
Arthrocare Corp.
Orthopedic · 20d
Cleared May 17, 2010
HANDHELD PULSE OXIMETER MODEL MD300A/ MD300K2/ MD300M
K100203 · DQA
Beijing Choice Electronic Technololgy...
Anesthesiology · 112d
Cleared May 17, 2010
POLARIS SPINAL SYSTEM
K100220 · NKB
Ebi, L.P.
Orthopedic · 111d
Cleared May 17, 2010
ORTHOPEDIATRICS PEDILOC TIBIA PLATE SYSTEM
K100240 · HRS
OrthoPediatrics Corp.
Orthopedic · 110d
Cleared May 17, 2010
MICROLIFE NON-CONTACT INFRARED FOREHEAD THERMOMETER, MODEL FR1DZ1
K100953 · FLL
Microlife Intellectual Property GmbH
General Hospital · 41d
Cleared May 17, 2010
CLEARJET
K101094 · ODC
Easyglide , Ltd.
Gastroenterology & Urology · 27d
Cleared May 14, 2010
FREESTYLE Lite Blood Glucose Monitoring System and Freestyle Freedom Lite...
K092602 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 262d
Cleared May 14, 2010
MRI PATIENT POSITIONING DEVICES
K093738 · LNH
Medtec, Inc.
Radiology · 161d
Cleared May 14, 2010
SMART-READ EZTEST-STEAM SCBI AND TEST PACK
K093794 · FRC
Sgm Biotech, Inc.
General Hospital · 155d
Cleared May 14, 2010
LNCS OXIMETRY SENSORS, REPROCESSED LNCS OXIMETRY SENSORS
K094046 · DQA
Masimo Corporation
Anesthesiology · 134d
Cleared May 14, 2010
MODIFCATION TO: NUVASIVE NEUROVISION EMG ENDOTRACHEAL TUBE
K094054 · GWF
Nuvasive, Inc.
Neurology · 134d
Cleared May 14, 2010
HDL CHOLESTEROL (HDLX) ASSAY
K100010 · LBS
Beckman Coulter, Inc.
Chemistry · 130d
Cleared May 14, 2010
SUREFIT DUAL DISPERSIVE ELECTRODE
K100047 · GEI
Conmed Corporation
General & Plastic Surgery · 126d