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
36481–36504 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 01, 2014
SIVR56-T KIT
K133994 · DXJ
Barco N.V.
Cardiovascular · 340d
Cleared Dec 01, 2014
JULIET LL
K141135 · MAX
Spineart
Orthopedic · 214d
Cleared Dec 01, 2014
AmeriWater Heatsan, 3-phase, 208v, 60hz, AmeriWater Heatsan, 3-phase, 460V,...
K142285 · FIP
Ameriwater
Gastroenterology & Urology · 105d
Cleared Dec 01, 2014
Pressure Right, Single-Use, Disposable, Acupressure, Pressure-Sensitive Wrist...
K142471 · MVV
Pressure Point, Inc.
Neurology · 89d
Cleared Dec 01, 2014
Synapse 3D Liver and Kidney Analysis
K142521 · LLZ
Fujifilm Meidcal Systems U.S.A.,Inc.
Radiology · 84d
Cleared Dec 01, 2014
HairMax LaserComb, HairMax LaserComb
K142573 · OAP
Lexington International, LLC
General & Plastic Surgery · 80d
Cleared Dec 01, 2014
Chemtrue Multi-Panel DOA DIP Card Tests
K142580 · DKZ
Chemtron Biotech, Inc.
Toxicology · 77d
Cleared Dec 01, 2014
CD HORIZON Spinal System
K142591 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 77d
Cleared Dec 01, 2014
BP652N (HEM-6300-Z)
K142917 · DXN
Omron Healthcare, Inc.
Cardiovascular · 55d
Cleared Dec 01, 2014
Resolution Clip
K142973 · PKL
Boston Scientific Corporation
Gastroenterology & Urology · 48d
Cleared Dec 01, 2014
CD HORIZON Spinal System
K143141 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 28d
Cleared Nov 28, 2014
ZEN-7000,SYSTEM,FLUROSCOPIC X-RAY SYSTEM
K140041 · OWB
Genoray Co., Ltd.
Radiology · 324d
Cleared Nov 28, 2014
nva, nvp, nvt
K142594 · MAX
Nvision Biomedical Technologies, LLC
Orthopedic · 74d
Cleared Nov 28, 2014
Zimmer Plates and Screws (ZPS) - Non Sterile Plate Line Extensions,...
K143066 · HRS
Zimmer, Inc.
Orthopedic · 35d
Cleared Nov 26, 2014
GENESIS II
K133434 · JAA
Dornier Medtech America, Inc.
Radiology · 383d
Cleared Nov 26, 2014
DIMENSION LOCI FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4L, DIMENSION LOCI...
K140842 · CEC
Siemens Healthcare Diagnostics, Inc.
Chemistry · 238d
Cleared Nov 26, 2014
DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4, DIMENSION VISTA...
K140859 · CEC
Siemens Healthcare Diagnostics, Inc.
Chemistry · 237d
Cleared Nov 26, 2014
SYMETREX LONG TERM HEMODIALYSIS CATHETER
K140884 · MSD
Phase One Medical
Gastroenterology & Urology · 233d
Cleared Nov 26, 2014
APEX
K141158 · KPI
Incontrol Medical, LLC
Gastroenterology & Urology · 205d
Cleared Nov 26, 2014
RESOLVE BILIARY LOCKING DRAINAGE CATHETER
K141408 · FGE
Merit Medical Systems, Inc.
Gastroenterology & Urology · 182d
Cleared Nov 26, 2014
AQUILION PRIME, V6.00
K141741 · JAK
Toshibamedical Systems Corporation
Radiology · 152d
Cleared Nov 26, 2014
MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
K142029 · HIH
Hologic, Inc.
Obstetrics & Gynecology · 124d
Cleared Nov 26, 2014
Xpert Norovirus, GeneXpert Dx Systems (GX-I, GX-11, GX-IV, GX-XVI), GeneXpert...
K142501 · PCH
Cepheid
Microbiology · 82d
Cleared Nov 26, 2014
Cytosponge Cell Collection Device
K142695 · EOX
Covidien, LLC
Ear, Nose, Throat · 65d