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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
78457–78480 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 09, 2001
MOSS MIAMI SPINAL SYSTEMS
K013296 · MNH
Depuyacromed
Orthopedic · 7d
Cleared Oct 09, 2001
MODIFICATION TO SENSITITRE YEASTONE MIC SUSCEPTIBILITY TEST
K991810 · NGZ
Trek Diagnostic Systems, Inc.
Microbiology · 866d
Cleared Oct 05, 2001
ZEUS ROBOTIC SURGICAL SYSTEM
K003431 · GCJ
Computer Motion, Inc.
General & Plastic Surgery · 336d
Cleared Oct 05, 2001
SOCRATES ROBOTIC TELEMONITORING SYSTEM
K003661 · NEQ
Computer Motion, Inc.
General & Plastic Surgery · 311d
Cleared Oct 05, 2001
W & H ASSISTINA
K010127 · EFB
A-Dec, Inc.
Dental · 275d
Cleared Oct 05, 2001
THINNER RESOLVE FITNESS MONITOR/BODY SCALE, HEALTH-O-METER
K010706 · MNW
Measurement Specialties, Inc.
Gastroenterology & Urology · 210d
Cleared Oct 05, 2001
INTERCOSTAL LOCKABLE-DIRECTABLE PORT
K011349 · DRC
Medcanica, Inc.
Cardiovascular · 156d
Cleared Oct 05, 2001
COM-PATCH
K012140 · GXY
Apex Medical Corp.
Neurology · 87d
Cleared Oct 05, 2001
SOPRO595 INTRA ORAL CAMERA
K012505 · EIA
Sopro
Dental · 63d
Cleared Oct 05, 2001
ALWAYS DUETS
K012629 · HHD
Procter & Gamble Co.
Obstetrics & Gynecology · 53d
Cleared Oct 05, 2001
ISOLA SPINAL SYSTEMS
K012971 · MNH
Depuyacromed
Orthopedic · 30d
Cleared Oct 05, 2001
MODIFICATION TO PRECISE NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K012993 · FGE
Cordis Corp.
Gastroenterology & Urology · 29d
Cleared Oct 05, 2001
INION CPS 2.0 ORTHOGNATHIC PLATE
K013039 · JEY
Inion , Ltd.
Dental · 25d
Cleared Oct 05, 2001
DIASUS
K013142 · IYO
Dynamic Imaging , Ltd.
Radiology · 15d
Cleared Oct 05, 2001
CEREBRAL BLOOD FLOW ANALYSIS SYSTEM (CBP), MODEL NUMBER CSCP-001A
K013214 · JAK
Toshiba America Medical Systems, In.C
Radiology · 9d
Cleared Oct 04, 2001
END EXPIRATORY FILTER, MODEL RT020
K002839 · CAH
Fisher &Paykel Healthcare , Ltd.
General Hospital · 387d
Cleared Oct 04, 2001
MONOLYTH MIMESYS HOLLOW FIBER OXYGENATOR
K004001 · DTZ
Dideco
Cardiovascular · 282d
Cleared Oct 04, 2001
C. NET 2100
K010396 · MLO
Cardionetics, Ltd.
Cardiovascular · 237d
Cleared Oct 04, 2001
AL-40
K010715 · GEX
Ddc Technologies, Inc.
General & Plastic Surgery · 209d
Cleared Oct 04, 2001
MEGABEAM/CERALAS REUSEABLE HANDPIECE AND DISPOSABLE TIPS
K010804 · GEX
Biolitec, Inc.
General & Plastic Surgery · 202d
Cleared Oct 04, 2001
PULSEMASTER ERBIUM DENTAL LASER SYSTEM
K012127 · GEX
American Dental Technologies, Inc.
General & Plastic Surgery · 87d
Cleared Oct 04, 2001
THE QUIET SLEEPER
K012142 · LRK
Precision Dental Laboratories, Inc.
Dental · 86d
Cleared Oct 04, 2001
DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL...
K012235 · KPM
Denver Biomedical, Inc.
Gastroenterology & Urology · 79d
Cleared Oct 04, 2001
THERMO DMA FRUCTOSAMINE ASSAY, MODEL 7500-135/235
K012525 · LCP
Thermo Dma, Inc.
Chemistry · 59d