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
19249–19272 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 31, 2020
CONFIDENCE Spinal Cement System
K201831 · NDN
Depuy Spine, Inc.
Orthopedic · 60d
Cleared Aug 31, 2020
Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology
K202251 · NRY
Penumbra, Inc.
Neurology · 21d
Cleared Aug 30, 2020
LabPro Data Management System
K201405 · LON
Beckman Coulter, Inc.
Microbiology · 94d
Cleared CT Aug 29, 2020
Masimo O3 Regional Oximeter System
K201432 · MUD
Masimo Corporation
General & Plastic Surgery · 89d
Cleared Aug 28, 2020
Orthodontic Fixation Screw [Smart Anchor Miniscrew]
K191041 · OAT
Gni Co., Ltd.
Dental · 497d
Cleared Aug 28, 2020
FitRelief TENS&EMS Wireless Device
K191938 · NGX
Heat IN A Click, LLC
Neurology · 406d
Cleared Aug 28, 2020
Hemostatic Xerogel Sponge
K192671 · QSY
Solaplus Biotech Co., Ltd.
General & Plastic Surgery · 337d
Cleared Aug 28, 2020
DIMI RRT System
K193005 · KDI
Dialco Medical, Inc.
Gastroenterology & Urology · 305d
Cleared Aug 28, 2020
OES Elite Ureteroscopes and Accessories
K200369 · FGB
Olympus Winter & Ibe GmbH
Gastroenterology & Urology · 196d
Cleared Aug 28, 2020
Infinity M300
K200859 · MHX
Draeger Medical Systems, Inc.
Cardiovascular · 149d
Cleared Aug 28, 2020
OrthoGold 100
K200926 · PZL
Tissue Regeneration Technologies, LLC
General & Plastic Surgery · 143d
Cleared Aug 28, 2020
MODULIF-A Anterior Lumbar Interbody Fusion System
K200958 · MAX
Spinal Stability, LLC
Orthopedic · 140d
Cleared Aug 28, 2020
Temno Elite Biopsy System
K201166 · KNW
Merit Medical Systems, Inc.
Gastroenterology & Urology · 119d
Cleared CT Aug 28, 2020
Jada System
K201199 · OQY
Alydia Health
Obstetrics & Gynecology · 116d
Cleared Aug 28, 2020
DreaMed Advisor Pro
K201476 · QCC
DreaMed Diabetes, Ltd.
Chemistry · 86d
Cleared Aug 28, 2020
AOS Galileo™ Trochanteric Nail System
K202099 · HSB
Advanced Orthopaedic Solutions, Inc.
Orthopedic · 30d
Cleared Aug 28, 2020
External Counterpulsation System, Soulaire
K202108 · DRN
Vamed Medical Instrument Co., Ltd.
Cardiovascular · 29d
Cleared Aug 28, 2020
SpaceOAR System
K202224 · OVB
Boston Scientific Corporation
Radiology · 21d
Cleared Aug 27, 2020
Konix Anti-Fog Solution
K190864 · OCT
Turkuaz Saglik Hizmetleri Medikal...
Gastroenterology & Urology · 512d
Cleared Aug 27, 2020
Nucleoss T6 Dental Implant System
K192062 · DZE
Sanlilar Tibbi Cihazlar Medikal Kimya...
Dental · 392d
Cleared Aug 27, 2020
APTOS Threads – Polypropylene Surgical Sutures
K192953 · GAW
Aptos, LLC
General & Plastic Surgery · 311d
Cleared Aug 27, 2020
Oral-B iO Test Drive Power Brush Trial Program Kit
K200881 · JEQ
The Procter & Gamble Company
Dental · 147d
Cleared Aug 27, 2020
Synapse 3D Cardiac Tools
K200973 · LLZ
Fujifilm Corporaton
Radiology · 136d
Cleared Aug 27, 2020
Next Generation Balloon Dilation System
K201115 · LRC
Acclarent, Inc.
Ear, Nose, Throat · 122d