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
38905–38928 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 25, 2014
INSULIN PEN NEEDLE
K133058 · FMI
Wenzhou Wuzhou Import & Export Co., Ltd.
General Hospital · 151d
Cleared Feb 25, 2014
INSULIN PEN NEEDLE
K133059 · FMI
Wenzhou Beipu Science & Technology...
General Hospital · 151d
Cleared Feb 25, 2014
CISNAP CLOSED INCISION SYSTEM
K133137 · OKO
Spiracur, Inc.
General & Plastic Surgery · 137d
Cleared Feb 25, 2014
ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, ZIMMER PATIENT SPECIFIC...
K133162 · JWH
Materialise NV
Orthopedic · 131d
Cleared CT Feb 25, 2014
MODIFIED HD GUIDE CATHETER
K133177 · DQY
Concentric Medical, Inc.
Cardiovascular · 131d
Cleared Feb 25, 2014
PRESSON SPINAL FIXATION SYSTEM
K133287 · MNH
Nexus Spine, LLC
Orthopedic · 123d
Cleared Feb 25, 2014
SICAT FUNCTION
K133320 · LLZ
Sicat GmbH & Co. KG
Radiology · 120d
Cleared Feb 25, 2014
LEADLINER CS LEAD DELIVERY SYSTEM
K133501 · DQY
Vascular Solutions, Inc.
Cardiovascular · 103d
Cleared Feb 25, 2014
SYNGO.VIA MI WORKFLOWS
K133644 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 90d
Cleared Feb 25, 2014
NEODENT IMPLANT SYSTEM
K133696 · NHA
Jjgc Industria E Comercio DE...
Dental · 84d
Cleared Feb 25, 2014
CD HORIZON SPINAL SYSTEM GROWTH ROD SET
K133904 · PGM
Medtronic Sofamor Danek USA
Orthopedic · 67d
Cleared Feb 25, 2014
WONDFO MULTI-DRUG URINE TEST CUP, PANEL
K133968 · DKZ
Guangzhou Wondfo Biotech Co., Ltd.
Chemistry · 61d
Cleared Feb 25, 2014
INTONEMV
K134020 · KPI
Incontrol Medical, LLC
Gastroenterology & Urology · 57d
Cleared Feb 25, 2014
MICROCUTTER XCHANGE 30 STAPLER, MICROCUTTER XCHANGE 30 BLUE CARTRIDGE
K140118 · GDW
Cardica, Inc.
General & Plastic Surgery · 40d
Cleared Feb 24, 2014
MATRICEL DENTAL BARRIER MEMBRANE
K123697 · NPL
Matricel GmbH
Dental · 448d
Cleared Feb 24, 2014
PURITAN BENNETT 980 SERIES VENTILATOR SYSTEM
K131252 · CBK
Covidien
Anesthesiology · 298d
Cleared Feb 24, 2014
DALTON LIFT CHAIR
K131909 · INO
Dalton Instrument Corp.
Physical Medicine · 243d
Cleared Feb 24, 2014
AIR-FLOW HANDY 3.0 PERIO
K132480 · EFB
E.M.S Electro Medical Systems S.A
Dental · 200d
Cleared Feb 24, 2014
IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS,...
K133404 · DGC
Phadia AB
Immunology · 110d
Cleared Feb 24, 2014
EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES
K133447 · NAJ
Celonova Biosciences, Inc.
Obstetrics & Gynecology · 104d
Cleared Feb 24, 2014
NEODENT IMPLANT SYSTEM
K133510 · DZE
Jj Industria E Comercio DE Materiais...
Dental · 102d
Cleared Feb 24, 2014
WELL LEAD PVC HYDROPHILIC URETHRAL CATHETER
K133615 · EZD
Well Lead Medical Co., Ltd.
Gastroenterology & Urology · 91d
Cleared Feb 24, 2014
AGILITY 10 STANDARD & SOFT 0.01IN. X 195CM, AGILITY 14 STANDARD & SOFT...
K133625 · MOF
Codman & Shurtleff, Inc.
Neurology · 90d
Cleared Feb 24, 2014
EXTRIMILOCK ANKLE PLATING SYSTEM
K133691 · HRS
Osteomed LP
Orthopedic · 84d