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
148969–148992 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 16, 1985
KONTRON SUPERMON 7210 PATIENT MONITOR
K844731 · DRT
Kontron Instruments, Inc.
Cardiovascular · 163d
Cleared May 16, 1985
OPTI-FLOW & OPTI-TORQUE ANGIOGRAPHIC CATHETERS
K844800 · DQO
Vas-Cath of Canada , Ltd.
Cardiovascular · 156d
Cleared May 16, 1985
DESERET INTRODUCER SET
K844840 · DYB
Parke-Davis Co.
Cardiovascular · 155d
Cleared May 16, 1985
ADV CARDIO SYS DBL LUMEN BALLOON DILATA CATHETER
K844972 · LIT
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 143d
Cleared May 16, 1985
MEDWATCH 400 CARDIAC CENTRAL NURSES STATION
K850135 · DRT
Medwatch Systems, Inc.
Cardiovascular · 122d
Cleared May 16, 1985
RESTING ECG SOFTWARE FRO G-2000 ELECTROCARDIOGRAPH
K850322 · DPS
Eaton Medical Group
Cardiovascular · 108d
Cleared May 16, 1985
TELEMETRY SOFTWARE FOR G-2000 ELECTROCARDIOGRAPH
K850323 · DPS
Eaton Medical Group
Cardiovascular · 108d
Cleared May 16, 1985
GAMBRO PLASMAFILTRATION SYSTEM
K850621 · LKN
Gambro, Inc.
Gastroenterology & Urology · 90d
Cleared May 16, 1985
WSP CODE 4301 DIOMASTER THERAPEUTIC
K850695 · FAP
Warne Surgical Products, Ltd.
Gastroenterology & Urology · 84d
Cleared May 16, 1985
ACCUTRACKER HEART-RATE MONITOR
K850867 · DXN
Eutectic Electronics, Inc.
Cardiovascular · 76d
Cleared May 16, 1985
ACTION-WHEELS & PLAY WHEELS
K850875
Ketronic, Inc.
Physical Medicine · 76d
Cleared May 16, 1985
LIGTVOET L80.2 LIGHTFOOT L80.2 POWER WHEELCHAIR
K850876 · ITI
Ketronic, Inc.
Physical Medicine · 76d
Cleared May 16, 1985
BP/CLINIC SYS MEASUREMENT, BP NON-INVASIVE
K850893 · DXN
Sun Dance Technology, Inc.
Cardiovascular · 73d
Cleared May 16, 1985
CARDIOTOMY RESERVOIR BRS-XXX & HOLDER BRS-HXX
K851004 · DTP
Gish Biomedical, Inc.
Cardiovascular · 65d
Cleared May 16, 1985
AMERICAN BENTLEY OXYGENATOR MAX-2
K851035 · DTZ
American Bentley
Cardiovascular · 64d
Cleared May 16, 1985
NORELCO BLOOD PRESSURE METER
K851049 · DXN
Philips Park
Cardiovascular · 63d
Cleared May 16, 1985
UMI ANGIOGRAPHIC CATHETER
K851088 · DQO
Universal Medical Instrument Corp.
Cardiovascular · 59d
Cleared May 16, 1985
VASOSCREEN IMPEDANCE PLETHYSMOGRAPH
K851102 · DQB
Sonicaid, Inc.
Cardiovascular · 58d
Cleared May 16, 1985
TELEFLEX MEDICAL INTRODUCER CATHETER
K851141 · DYB
Teleflexmedical, Inc.
Cardiovascular · 56d
Cleared May 16, 1985
PERSONAL C3 3-CHANNEL ELECTROCARDIOGRAPH
K851322 · DPS
Parexel Intl. Corp.
Cardiovascular · 44d
Cleared May 16, 1985
MARLIN CONTACT LENS CASE
K851497 · HPX
Marlin Industries
Ophthalmic · 31d
Cleared May 16, 1985
COOK PACEMAKER CORP. 332T BIPOLAR CARDIAC PULSE GE
K851699 · DXY
Cook Pacemaker Corp.
Cardiovascular · 22d
Cleared May 16, 1985
STERILE GOWNS, MASKS & TOWELS
K851853
Biological & Environmental Control...
General & Plastic Surgery · 20d
Cleared May 16, 1985
PROGRAMALITH III MODEL 249 PULSE GENERATOR
K851861 · DXY
Pacesetter Systems
Cardiovascular · 20d