FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
77857–77880 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Oct 04, 2001
DISPOSABLE POWDERED VINYL EXAMINATION GLOVES
K012710 · LYZ
Shijiazhuang Brilliance Plastic Co.,...
General Hospital · 51d
Cleared Oct 04, 2001
ARTHREX FIBERWIRE, USP SIZE 5, MODEL AR-7201
K012923 · GAT
Arthrex, Inc.
General & Plastic Surgery · 34d
Cleared Oct 04, 2001
URETEX SUP PUBOURETHRAL SLING
K012949 · OTN
Sofradim Production
Gastroenterology & Urology · 30d
Cleared Oct 04, 2001
MODIFICATION TO: MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM
K012950 · DXT
Medrad, Inc.
Cardiovascular · 30d
Cleared Oct 04, 2001
MODIFICATION TO FIXION INTERLOCKING PROXIMAL FEMORAL INTRAMEDULLARY NAILING...
K012967 · HSB
Disco-O-Tech Medical Technologies, Ltd.
Orthopedic · 30d
Cleared Oct 04, 2001
BLOCK CEMENT RESTRICTOR (CR) - TITANIUM
K013014 · JDK
Medtronic Sofamor Danek, Inc.
Orthopedic · 27d
Cleared Oct 04, 2001
MODIFICATION TO: THERMACOOL IIA
K013034 · GEI
Thermage, Inc.
General & Plastic Surgery · 24d
Cleared Oct 03, 2001
MEDCOMP EXCELL SPLIT TIP CATHETER
K010306 · MSD
Medcomp
Gastroenterology & Urology · 244d