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
147169–147192 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 27, 1985
INTRA VAGINAL TRANSDUCER
K853407 · HEM
Advanced Technology Laboratories, Inc.
Obstetrics & Gynecology · 46d
Cleared Sep 27, 1985
PERFECT 10
K853498 · EJH
North American Alloys, Inc.
Dental · 38d
Cleared Sep 26, 1985
ADENOVIRUS
K843649 · GOD
Institute Virion , Ltd.
Microbiology · 374d
Cleared Sep 26, 1985
CYTOMEGALOVIRUS
K843657 · GQH
Institute Virion , Ltd.
Microbiology · 374d
Cleared Sep 26, 1985
H. SIMPLEX VIRUS
K843658 · GQN
Institute Virion , Ltd.
Microbiology · 374d
Cleared Sep 26, 1985
INFLUENZA A2 VIRUS
K843659 · GNX
Institute Virion , Ltd.
Microbiology · 374d
Cleared Sep 26, 1985
IN FLUENZA B VIRUS
K843660 · GNX
Institute Virion , Ltd.
Microbiology · 374d
Cleared Sep 26, 1985
MEASLES VIRUS RUBEOLA
K843662 · GRJ
Institute Virion , Ltd.
Microbiology · 374d
Cleared Sep 26, 1985
PARAINFLUENZA 1
K843665 · GQS
Institute Virion , Ltd.
Microbiology · 374d
Cleared Sep 26, 1985
PARAINFLUENZA 3
K843667 · GQS
Institute Virion , Ltd.
Microbiology · 374d
Cleared Sep 26, 1985
RESPIRATORY SYNCYTIAL VIRUS
K843673 · GQG
Institute Virion , Ltd.
Microbiology · 374d
Cleared Sep 26, 1985
VARICELLA/ZOSTER VIRUS
K843676 · GQW
Institute Virion , Ltd.
Microbiology · 374d
Cleared Sep 26, 1985
TRAUMA CARE EVALUATION
K843905 · PLB
Quantitative
General Hospital · 358d
Cleared Sep 26, 1985
CLINICOMP RDMS RADIONUCLIDE DISPENSING MGMT. SOFTW
K850838 · KPT
Clinicomp, Inc.
Radiology · 209d
Cleared Sep 26, 1985
BONE DENSITY CT PHANTOM
K852528 · IXG
Computerized Imaging Reference...
Radiology · 104d
Cleared Sep 26, 1985
MAXI-NEB
K852627 · CCQ
Ashai Co. , Ltd.
Anesthesiology · 98d
Cleared Sep 26, 1985
OSTEOGRAF AR ALVEOLAR RIDGE HYDROXYLAPATITE 18-40
K852742 · LYC
Coors Biomedical Co.
Dental · 91d
Cleared Sep 26, 1985
TRAUMA STAND
K852952 · IYB
Xre Corp.
Radiology · 77d
Cleared Sep 26, 1985
SUPERSPIRO
K853190 · BZM
Cdx Corp.
Anesthesiology · 58d
Cleared Sep 26, 1985
SENTRY FLEXIBLE TENS
K853552 · GXY
Sentry Medical Products, Inc.
Neurology · 31d
Cleared Sep 25, 1985
CARDIOTOMY/MEDIASTINAL AUTOTRANSFUSION RESERVOIR
K852382 · DTN
American Bentley
Cardiovascular · 112d
Cleared Sep 25, 1985
AMERICAN PHARMASEAL TRIPLE LUMEN CATHETER
K852491 · DQY
American Pharmaseal Div. Ahsc
Cardiovascular · 105d
Cleared Sep 25, 1985
CVERNE CAD DETECTOR
K852900 · DXG
Cherne Industries, Inc.
Cardiovascular · 78d
Cleared Sep 25, 1985
ANGIOGRAPHIC, WEDGE PRESS, DUAL THERMOD & INFUSION
K852914 · DQY
Norton Performance Plastics Corp.
Cardiovascular · 77d