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
146641–146664 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 14, 1985
LOGOS8821 1-CHANNEL DIRECT-WRITING ELECTROCARDIOGR
K851662 · DPS
Logos Medical Co., Ltd.
Cardiovascular · 205d
Cleared Nov 14, 1985
DIGIRAD SYSTEM 1 AND THE REUSUABLE IMAGE MEDIA
K852284 · LLZ
Digirad Corp.
Radiology · 169d
Cleared Nov 14, 1985
UNISTIM UNT-1
K852326 · GZB
Neuromed, Inc.
Neurology · 168d
Cleared Nov 14, 1985
GENTLE EXPRESSIONS AUTOMATIC BREAST PUMP & FEED SY
K852460 · HGX
Healthteam
Obstetrics & Gynecology · 157d
Cleared Nov 14, 1985
CILAS MODEL YM101
K852761 · LLO
Inframed, Inc.
Anesthesiology · 139d
Cleared Nov 14, 1985
CR5 CARDIAC MONITOR
K852887 · DRT
Cardiac Recorders, Ltd.
Cardiovascular · 128d
Cleared Nov 14, 1985
MVP - 6000
K852909 · BZC
Waters Instruments, Inc.
Anesthesiology · 128d
Cleared Nov 14, 1985
PCM DIGITAL AMBULA TORY ECG ANALYSIS SYSTEM
K852968 · DSI
Personal Computers For Medicine, Inc.
Cardiovascular · 122d
Cleared Nov 14, 1985
CMV TEST
K853137 · GQI
Gull Laboratories, Inc.
Microbiology · 111d
Cleared Nov 14, 1985
DIGITAL SPHYGMOMANOMETER MODEL 7620
K853158 · DXN
Takeda Medical, Inc.
Cardiovascular · 107d
Cleared Nov 14, 1985
FUKUDA DENSHI DS-1060 DYNASCOPE PATIENT MONITOR
K853352 · DSI
Fukuda Denshi USA, Inc.
Cardiovascular · 94d
Cleared Nov 14, 1985
SHILEY 3L CARDIOTOMY RESERVOIR
K853503 · DTP
Shiley, Inc.
Cardiovascular · 85d
Cleared Nov 14, 1985
SARNS RETROGRADE CARDIOPLEGIA DELIVERY SYSTEM
K853516 · DTR
3M Health Care, Sarns
Cardiovascular · 84d
Cleared Nov 14, 1985
PRESSURE SENSING SYRINGE 65000
K853586 · DTL
Dlp, Inc.
Cardiovascular · 80d
Cleared Nov 14, 1985
MULTISTIM LAMINECTOMY ELECTRODE
K853643 · GZB
Neuromed, Inc.
Neurology · 72d
Cleared Nov 14, 1985
SCOTCHPRIME CERAMIC PRIMER
K853698 · EIH
3M Company
Dental · 71d
Cleared Nov 14, 1985
INDONTINENCE PAD
K853741
Beghin_Say Intl., Inc.
Gastroenterology & Urology · 69d
Cleared Nov 14, 1985
PLOTTER FOR AS-500
K853922 · BZH
Riko Medical & Scientific Instrument...
Anesthesiology · 52d
Cleared Nov 14, 1985
DIATEMP ELECTROSURGICAL PEN
K853968 · GEI
Ndm Corp.
General & Plastic Surgery · 49d
Cleared Nov 14, 1985
SCEPTOR PSEUDOMONAS PLUS MIC/ID PANEL
K854097 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 38d
Cleared Nov 14, 1985
SCEPTOR PSEUDOMONAS PLUS MIC PANEL
K854098 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 38d
Cleared Nov 14, 1985
SCEPTOR GRAM NEGATIVE URINE ISOLATE MIC/ID PANEL
K854099 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 38d
Cleared Nov 14, 1985
SCEPTOR GRAM POSITIVE MIC/ID PANEL
K854100 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 38d
Cleared Nov 14, 1985
SCEPTOR GRAM POSITIVE MIC PANEL
K854101 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 38d