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
42193–42216 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 29, 2013
IMAGEQUBE
K124048 · LLZ
Intuitive Imaging Informatics, LLC
Radiology · 29d
Cleared Jan 28, 2013
ORTHOCON ABSORBABLE HEMOSTATIC BONE PUTTY
K122156 · MTJ
Orthocon, Inc.
General & Plastic Surgery · 192d
Cleared CT Jan 28, 2013
AXERA 2 ACCESS SYSTEM MODEL AXE200
K123135 · DYB
Arstasis, Inc.
Cardiovascular · 115d
Cleared Jan 28, 2013
MULTIPLE NAME
K123760 · LZA
Assurguard Sdn. Bhd.
General Hospital · 52d
Cleared Jan 25, 2013
ESWALLOW USA ELECTRODE,ESWALLOW USA LEADWIRE
K113375 · GXY
Eswallow USA
Neurology · 436d
Cleared Jan 25, 2013
LANTOS 3D EAR SCANNER
K121326 · ERA
Lantos Technologies
Ear, Nose, Throat · 268d
Cleared Jan 25, 2013
BACT/ALERT PF PLUS CULTURE BOTTLE
K121446 · MDB
bioMerieux, Inc.
Microbiology · 255d
Cleared Jan 25, 2013
BACT/ALERT FN PLUS CULTURE BOTTLE
K121455 · MDB
bioMerieux, Inc.
Microbiology · 254d
Cleared Jan 25, 2013
MEDYSSEY CANNULATED PEDICLE SCREW
K121670 · NKB
Medyssey Co, Ltd.
Orthopedic · 233d
Cleared Jan 25, 2013
ESA615
K121860 · DRT
Fluke Biomedical
Cardiovascular · 213d
Cleared Jan 25, 2013
ASA LASER SH1
K122125 · ILY
El.En Electronic Engineering Spa
Physical Medicine · 191d
Cleared Jan 25, 2013
SYSTEM 83 PLUS
K122172 · FEB
Custom Ultrasonics
General Hospital · 186d
Cleared Jan 25, 2013
LIAISON TESTOSTERONE
K122793 · CDZ
DiaSorin, Inc.
Chemistry · 135d
Cleared Jan 25, 2013
ENSEAL G2 ARTICULATING TISSUE SEALERS, STRAIGHT JAW, ENSEAL G2 ARTICULATING...
K122797 · GEI
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 135d
Cleared Jan 25, 2013
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700 GE GE200 BLOOD GLUCOSE...
K123008 · NBW
Bionime Corporation
Chemistry · 120d
Cleared Jan 25, 2013
SMITH & NEPHEW, INC SCREW AND PLATE SYSTEM INSTRUMENTATION
K123055 · HRS
Smith & Nephew, Inc.
Orthopedic · 116d
Cleared Jan 25, 2013
REPROCESSED VESSEL SEALER
K123096 · NUJ
Sterilmed, Inc.
General & Plastic Surgery · 115d
Cleared CT Jan 25, 2013
ZERONA 2.0 LASER
K123237 · OLI
Erchonia Corporation
General & Plastic Surgery · 101d
Cleared Jan 25, 2013
VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS), AND TRUFILL DCS ORBIT...
K123560 · HCG
Codman & Shurtleff, Inc.
Neurology · 67d
Cleared Jan 25, 2013
2.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 035
K123632 · MCW
Spectranetics Corp.
Cardiovascular · 63d
Cleared Jan 25, 2013
DECLIPSESPECT VIEWER
K123917 · IZD
Surgiceye GmbH
Radiology · 37d
Cleared Jan 25, 2013
POWER LED 175
K123956 · FCW
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 35d
Cleared Jan 25, 2013
GLUCOSE METER-CHECK SOLUTION FOR BAYER
K123966 · JJX
Bionostics, Inc.
Chemistry · 30d
Cleared Jan 24, 2013
DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SET
K112120 · GHH
Diazyme Laboratories
Hematology · 549d