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
147313–147336 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 17, 1985
ENDOCARDIAL SCREW-IN LEAD WITH PLATINUM POROUS TIP
K852446 · DTB
Diag Corp.
Cardiovascular · 99d
Cleared Sep 17, 1985
ABBOTT RSV EIA
K852472 · LKT
Abbott Laboratories
Microbiology · 98d
Cleared Sep 17, 1985
THROMBO SCREEEN FIBRIN DEGRADATION PRODUCT KIT
K852512 · GHH
Pacific Hemostasis
Hematology · 97d
Cleared Sep 17, 1985
IMPLANT ELECT LEAD, MOD 30-403 USING POLYU 90 A
K852709 · DTB
Telectronics, Inc.
Cardiovascular · 83d
Cleared Sep 17, 1985
SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD,#30-401
K853221 · DTB
Telectronics, Inc.
Cardiovascular · 47d
Cleared Sep 17, 1985
SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD, #30-402
K853222 · DTB
Telectronics, Inc.
Cardiovascular · 47d
Cleared Sep 17, 1985
SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD, #30-407
K853223 · DTB
Telectronics, Inc.
Cardiovascular · 47d
Cleared Sep 17, 1985
COLUMBIZ BLOOD AGAR
K853690 · JSG
Micro Media Laboratories
Microbiology · 13d
Cleared Sep 17, 1985
TERGITOL 7 AGAR
K853691 · JSI
Micro Media Laboratories
Microbiology · 13d
Cleared Sep 16, 1985
SURGICAL ASPIRATOR
K850946 · BTA
Medicalex
General & Plastic Surgery · 193d
Cleared Sep 16, 1985
FLUORESCENT MICROBEAD ALIGNMENT STANDARDS TM
K851450 · JIW
Flow Cytometry Standards Corp.
Microbiology · 158d
Cleared Sep 16, 1985
CARBOCONE
K851732 · DRX
Imtech Corp.
Cardiovascular · 144d
Cleared Sep 16, 1985
CORDIS HIGH-TORQUE TEMP. PERVENOUS LEAD W/DEPTH MA
K851913 · LDF
Cordis Corp.
Cardiovascular · 138d
Cleared Sep 16, 1985
HEMATOCRIT-SATURATION MONITOR HSM-100
K852124 · DRY
American Bentley
Cardiovascular · 124d
Cleared Sep 16, 1985
REFLOTRON SYSTEM
K852133 · JJE
Boehringer Mannheim Corp.
Chemistry · 123d
Cleared Sep 16, 1985
STERILIZATION CONTAINER
K852335 · FRG
Bemis Mfg. Co.
General Hospital · 108d
Cleared Sep 16, 1985
GAMBRO DIGITAL TELETHERMOMETER TTH 10-200
K852455 · KRI
Gambro, Inc.
Cardiovascular · 98d
Cleared Sep 16, 1985
SAF-D-FIB
K852469 · DRX
Medtronic Andover Medical, Inc.
Cardiovascular · 95d
Cleared Sep 16, 1985
ENZYGNOST + ANTI-CMV IGG TEST
K852478 · LFZ
Behring Diagnostics, Inc.
Microbiology · 97d
Cleared Sep 16, 1985
CMV-IHA
K852494 · LJO
Hillcrest Biologicals
Microbiology · 96d
Cleared Sep 16, 1985
115-GK BARD CARE TRANSLU VENTRICULAR PACING LEAD
K852513 · LDF
C.R. Bard, Inc.
Cardiovascular · 96d
Cleared Sep 16, 1985
MICROTRAK CHLAMYDIA TRACHOMATIS DIR SPECIMEN TEST
K852779 · LJP
Syva Co.
Microbiology · 77d
Cleared Sep 16, 1985
HEPARIN COAT TRAN BALLO TIP TEMP PAC ELECTRODE
K852797 · LDF
Mansfield Scientific, Inc.
Cardiovascular · 80d
Cleared Sep 16, 1985
2006, 2010, 2011, 2012(CARDIAC DC DEFIBRILLATOR)
K852799 · LDD
Cardiac Recorders, Ltd.
Cardiovascular · 77d