FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
73225–73248 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 22, 2002
SOMATOM EMOTION 6 CT SYSTEMS
K023687 · JAK
Siemens Medical Systems, Inc.
Radiology · 21d
Cleared Nov 22, 2002
CANNON DIGITAL RADIOGRAPHY MODEL CXDI-40G
K023750 · MQB
Canon USA, Inc.
Radiology · 14d
Cleared Nov 22, 2002
CT CARDIAC FUNCTION ANALYSIS SOFTWARE, MODELS CSCF-001A AND CSCF-001B
K023760 · JAK
Toshiba America Medical Systems, In.C
Radiology · 14d
Cleared Nov 22, 2002
KINETDX PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
K023772 · LLZ
Acuson Corp.
Radiology · 10d
Cleared Nov 21, 2002
POLYGRAM NET ELECTROGASTROGRAPHY APPLICATION SOFTWARE, MODEL 9043S0151
K014269 · MYE
Medtronic Functional Diagnostics A/S
Gastroenterology & Urology · 329d
Cleared Nov 21, 2002
EQUILASE SYSTEM
K022464 · GEX
Equilasers, Inc.
General & Plastic Surgery · 118d
Cleared Nov 21, 2002
ALPHATRAC, MODEL A 205
K022652 · ITI
Teftec Corp.
Physical Medicine · 104d
Cleared Nov 21, 2002
TRIDENT SCREW HOLE PLUG AND TRIDENT BONE SPIKE
K022799 · JDI
Howmedica Osteonics Corp.
Orthopedic · 90d
Cleared Nov 21, 2002
ATLANTIS PV IMAGING CATHETER, MODEL 36456
K022860 · ITX
Boston Scientific, Target
Radiology · 85d
Cleared Nov 21, 2002
BLOOD PRESSURE MONITOR SMARTLOGIC, MODELS KP-6210 AND KP-6211
K022916 · DXN
K-Jump Health Co., Ltd.
Cardiovascular · 79d
Cleared Nov 21, 2002
TRX VERTICAL POSITIONER
K023426 · ITI
Motion Concepts
Physical Medicine · 41d
Cleared Nov 21, 2002
WIZAIR COMPRESSION SYSTEM
K023573 · JOW
Medical Compression Systems (Dbn) , Ltd.
Cardiovascular · 28d
Cleared Nov 21, 2002
FLOSTAR NEEDLELESS CONNECTOR, MODEL FS3000
K023585 · FPA
Intravascular Incorporated
General Hospital · 27d
Cleared Nov 21, 2002
STOCKERT PEDIATRIC AORTIC CANNULAE, MODEL NUMBERS A272-15 THROUGH A272-35
K023622 · DWF
Stockert Instrumente GmbH
Cardiovascular · 23d
Cleared Nov 21, 2002
DIGITAL THERMOMETER CLASSIC TYPE AND FLEXIBLE TYPE
K023711 · FLL
Acute Ideas Co. , Ltd.
General Hospital · 17d
Cleared Nov 20, 2002
CYNOSURE PHOTOGENICA SV
K021444 · GEX
Cynosure, Inc.
General & Plastic Surgery · 198d
Cleared Nov 20, 2002
QUICKLAB RSV
K021789 · GQG
Integrated Biotechnology Corp.
Microbiology · 173d
Cleared Nov 20, 2002
OTI UNICONDULAR INTERPOSITIONAL SPACER
K022779 · HSH
Osteoimplant Technology, Inc.
Orthopedic · 90d
Cleared Nov 20, 2002
IMAGECHECKER-CT WORKSTATION
K023003 · LLZ
R2 Technology, Inc.
Radiology · 72d
Cleared Nov 20, 2002
SONOREAL 3D
K023473 · IYO
Bio Medi Com
Radiology · 35d
Cleared Nov 20, 2002
6 CHANNEL BODY COIL
K023571 · MOS
Siemens Medical Systems, Inc.
Radiology · 27d
Cleared Nov 20, 2002
ASCENSIA DEX 2 DIABETES CARE SYSTEM
K023584 · NBW
Bayer Corp.
Chemistry · 26d
Cleared Nov 20, 2002
SONOLINE ANTARES ULTRASOUND SYSTEM
K023720 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 15d
Cleared Nov 19, 2002
NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS)
K013694 · NFJ
Nidek, Inc.
Ophthalmic · 377d