FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
30457–30480 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 05, 2016
EZstim*III Peripheral Nerve Stimulator/Nerve Locator
K162048 · KOI
Halyard Health - Irvine
Anesthesiology · 133d
Cleared Dec 05, 2016
Bencox M Stem Lateralized & Bencox Mirabo Cup System
K162127 · LPH
Corentec Co., Ltd.
Orthopedic · 126d
Cleared Dec 05, 2016
Tri-Staple 2.0 Intelligent Cartridge
K163098 · GDW
Covidien, LLC
General & Plastic Surgery · 28d
Cleared Dec 05, 2016
Discovery Pico Family
K163222 · GEX
Quanta System Spa
General & Plastic Surgery · 19d
Cleared Dec 02, 2016
Altrix Precision Temperature Management System
K152266 · DWJ
Stryker Medical
Cardiovascular · 479d
Cleared Dec 02, 2016
TAV System
K152664 · ONZ
New Aera, Inc.
Anesthesiology · 442d
Cleared Dec 02, 2016
FS-500DDR Medical Radiographic X-Ray System
K152813 · KPR
Orich Medical Equipment (Tianjin Co.,...
Radiology · 431d
Cleared Dec 02, 2016
V-varnish Premium
K160377 · LBH
Vericom Co., Ltd.
Dental · 296d
Cleared Dec 02, 2016
Cerasorb Ortho Foam
K160566 · MQV
Curasan AG
Orthopedic · 277d
Cleared Dec 02, 2016
Chrono-log Platelet Aggregometer, 4 channel
K161329 · JOZ
Chrono-Log Corp.
Hematology · 204d
Cleared Dec 02, 2016
GE Lunar DXA Bone Densitometers with enCORE version 17
K161682 · KGI
GE Medical Systems Ultrasound &...
Radiology · 168d
Cleared Dec 02, 2016
Reliance Spinal Screw System
K162066 · MNH
Reliance Medical Systems, LLC
Orthopedic · 129d
Cleared Dec 02, 2016
Pioneer Plus Catheter
K162418 · PDU
Philips Volcano
Cardiovascular · 94d
Cleared Dec 02, 2016
EVS 3643, EVS 3643G
K162552 · MQB
DRTECH Corporation
Radiology · 80d
Cleared Dec 02, 2016
Allura Xper FD series and Allura Xper OR Table series
K162859 · OWB
Philips Medical Systems Nederland B.V.
Radiology · 51d
Cleared Dec 02, 2016
ExactVu High Resolution Micro-Ultrasound System
K162972 · IYO
Exact Imaging
Radiology · 38d
Cleared Dec 02, 2016
MEDSYNAPSE Zero Footprint Viewer
K163158 · LLZ
Medsynaptic Private, Ltd.
Radiology · 22d
Cleared Dec 01, 2016
WoundPro Negative Pressure Wound Therapy System
K150960 · OMP
Pensar Medical, LLC
General & Plastic Surgery · 601d
Cleared Dec 01, 2016
EasyLyte Na/K/Cl/Ca Analyzer
K152327 · JFP
Medica Corporation
Chemistry · 471d
Cleared Dec 01, 2016
AK Body Toning Device
K152420 · NGX
Ak Beauty Enterprises, LLC
Physical Medicine · 463d
Cleared Dec 01, 2016
LOSPA Modular Knee System
K160157 · JWH
Corentec Co., Ltd.
Orthopedic · 314d
Cleared Dec 01, 2016
Invia Motion-Endure Negative Pressure Wound Therapy System, Invia...
K161128 · OMP
Medela AG
General & Plastic Surgery · 224d
Cleared Dec 01, 2016
Internal Distraction - Sterile
K161470 · MQN
KLS-Martin L.P.
Dental · 188d
Cleared Dec 01, 2016
Osseointegrated Fixtures
K161548 · FZE
Southern Implants (Pty), Ltd.
General & Plastic Surgery · 181d