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

Filters: Cleared only ×
175,820 results
147025–147048 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 15, 1985
ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE-HIGH SP
K854009 · DJP
Roche Diagnostic Systems, Inc.
Toxicology · 15d
Cleared Oct 11, 1985
IPG-300
K852238 · DSB
Thornton Associates, Inc.
Cardiovascular · 141d
Cleared Oct 11, 1985
ANGIOMEDICS SOFTIP CATHETER
K852872 · DQO
Angiomedics, Inc.
Cardiovascular · 95d
Cleared Oct 11, 1985
PACEPAC
K852958 · DRO
Medical Data Electronics
Cardiovascular · 91d
Cleared Oct 11, 1985
SHILEY CSD EXTENSION LINE WITH FILTER
K852984 · DWF
Shiley, Inc.
Cardiovascular · 88d
Cleared Oct 11, 1985
WILLIAM HARVEY HYBID OXYGENATOR H-1700
K853080 · DTZ
C.R. Bard, Inc.
Cardiovascular · 80d
Cleared Oct 11, 1985
BIO PACK MODEL 200
K853126 · DWA
Bio Medicus, Inc.
Cardiovascular · 78d
Cleared Oct 11, 1985
FUKUDA DENSHI MODEL/DS-1030A DYNASCOPE SERIES MON
K853213 · DSI
Fukuda Denshi USA, Inc.
Cardiovascular · 144d
Cleared Oct 11, 1985
CARDIO DATA PACERECORDER PR3
K853262 · DSH
Cardio Data
Cardiovascular · 67d
Cleared Oct 11, 1985
MEDIC 4
K853354 · LDD
Kone Instruments, Inc.
Cardiovascular · 60d
Cleared Oct 11, 1985
MODEL 492-03 POLYFLEX IMPLANTABLE PACING LEAD
K853410 · DTR
Intermedics, Inc.
Cardiovascular · 59d
Cleared Oct 11, 1985
MODEL 43130A DEFIBRILLATOR
K853439 · LDD
Hewlett-Packard Co.
Cardiovascular · 56d
Cleared Oct 11, 1985
LIFEPAK 200
K853564 · MKJ
Physio-Control Corp.
Cardiovascular · 46d
Cleared Oct 11, 1985
MEDTRONIC MODEL 6405
K853818 · LDF
Medtronic Vascular
Cardiovascular · 29d
Cleared Oct 10, 1985
DIAGNON HERPES IMMUNOPEROXIDASE TYPING TEST
K851635 · GQL
Diagnon Corp.
Microbiology · 175d
Cleared Oct 10, 1985
PC INTERFACE
K852771 · CBK
Siemens Elema AB
Anesthesiology · 105d
Cleared Oct 10, 1985
GAS EVACUATION ACCESSORY
K852772 · CBN
Siemens Elema AB
Anesthesiology · 105d
Cleared Oct 10, 1985
FDP ASSAY-20 TEST KIT
K852848 · GHH
American Bioproducts Co.
Hematology · 97d
Cleared Oct 10, 1985
OPTICAL DISC UNIT
K852865 · JAK
General Electric Co.
Radiology · 94d
Cleared Oct 10, 1985
QUADRA CATH ELECT(3MM SIZES) 1990J, JF, JP + JPF
K852920 · GZB
Neuromed, Inc.
Neurology · 92d
Cleared Oct 10, 1985
ESCHMANN ELECTROSURGICAL UNIT, MODEL TD411
K852935 · GEI
Eschmann Bros. & Walsh , Ltd.
General & Plastic Surgery · 92d
Cleared Oct 10, 1985
WORLD PORTABLE CAUTERY
K852942 · GEI
Sturgeon Engineering Co.
General & Plastic Surgery · 92d
Cleared Oct 10, 1985
PARA CHECK (AKA EIGHT CHECK-C)
K852992 · JPK
Streck Laboratories, Inc.
Hematology · 87d
Cleared Oct 10, 1985
PRESSURE GAUGE
K853040 · BXH
Erie Medical
Anesthesiology · 83d