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
46417–46440 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 22, 2011
27 G X 1/2 K-PACK SURSHIELD NEEDLE
K111797 · FMI
Terumo Europe N.V.
General Hospital · 90d
Cleared Sep 22, 2011
PD-100 SERIES ULTRASONIC POCKET DOPPLER
K111934 · KNG
Advanced Instrumentations, Inc.
Radiology · 76d
Cleared Sep 22, 2011
CORONIS FUSION 4MP DL
K111989 · LLZ
Barco N.V.
Radiology · 71d
Cleared Sep 22, 2011
DUS-3000/DUS-3000PLUS DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
K112022 · IYO
Advanced Instrumentations, Inc.
Radiology · 69d
Cleared Sep 22, 2011
RAPID INTRAVASCULAR CATHETER START SYSTEM 22 GAUGE / 20 GAUGE / 18 GAUGE
K112347 · FOZ
Vascular Pathways, Inc.
General Hospital · 38d
Cleared Sep 22, 2011
DIGITAL ELECTROCARDIOGRAPH
K112431 · DPS
Shenzhen Biocare Electronics Co., Ltd.
Cardiovascular · 30d
Cleared Sep 22, 2011
RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT
K112435 · ETN
Rhythmlink International, LLC
Ear, Nose, Throat · 29d
Cleared Sep 22, 2011
PULSIOFLEX
K112448 · DXG
Pulsion Medical Systems, Inc.
Cardiovascular · 28d
Cleared Sep 22, 2011
AIMING BLOCKS FOR VARIAX DISTAL RADIUS PLATES
K112455 · HRS
Howmedica Osteonics Corp., Dba...
Orthopedic · 28d
Cleared Sep 22, 2011
RADIFORCE LARGE MONITOR SYSTEM
K112645 · DXJ
Eizo GmbH
Cardiovascular · 10d
Cleared Sep 21, 2011
ACCU-CHEK AVIVA PLUS BLOOD GLUCOSE MONITORING SYSTEM
K101299 · LFR
Roche Diagnostics
Chemistry · 499d
Cleared Sep 21, 2011
CVM, UNCONJUGATED ESTRIOL (UE3) CALIBRATION VERIFICATION MATERIAL
K110061 · JJX
Siemens Healthcare Diagnostics
Chemistry · 254d
Cleared Sep 21, 2011
EASYGLUCO PLUS BLOOD GLUCOSE MONITORING SYSTEM
K110435 · NBW
U. S. Diagnostics, Inc.
Chemistry · 218d
Cleared Sep 21, 2011
TRIPLE LUMEN PFM PICC
K110914 · LJS
Pfm Medical, Inc.
General Hospital · 173d
Cleared Sep 21, 2011
ODALYS PEDICLE SCREW SYSTEM
K111370 · MNH
Kalitec Direct, LLC
Orthopedic · 128d
Cleared Sep 21, 2011
VIRTUE
K111833 · LLZ
Diagnosoft, Inc.
Radiology · 85d
Cleared Sep 21, 2011
SYNTHETIC VINYL EXAMINATION GLOVE POWDER FREE
K111857 · LYZ
Inmed Gloves Factory
General Hospital · 83d
Cleared Sep 21, 2011
STERILE POLYISOPRENE POWDER-FREE BLUE SURGICAL GLOVES WITH NEU-THERA...
K111868 · KGO
Cardinal Health-Medical Products and...
General Hospital · 82d
Cleared Sep 21, 2011
Z BOND, PRELUDE ONE
K111876 · KLE
Danville Materials, Inc.
Dental · 82d
Cleared Sep 21, 2011
ORTHO DEVLOPMENT CERAMIC FEMORAL HEAD
K111936 · LZO
Ortho Development
Orthopedic · 75d
Cleared Sep 21, 2011
VAGINAL CT / MR MULTI CHANNEL APPLICATOR SET
K111973 · JAQ
Nucletron
Radiology · 71d
Cleared Sep 21, 2011
CMS-1000FM CENTRAL MONITORING SYSTEM
K112159 · HGM
Advanced Instrumentations, Inc.
Obstetrics & Gynecology · 56d
Cleared Sep 21, 2011
FM-1000 PLUS FETAL MONITOR
K112187 · HGM
Advanced Instrumentations, Inc.
Radiology · 54d
Cleared Sep 20, 2011
NUCLEIC ACID DETECTION IMMUNOASSAY (NADIA) PSA ASSAY
K101185 · OWM
Iris Molecular Diagnostics
Immunology · 510d