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

Filters: Cleared only ×
175,820 results
21793–21816 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 18, 2019
Tetragraph Neuromuscular Transmission Monitor
K190795 · KOI
Senzime AB
Anesthesiology · 204d
Cleared Oct 18, 2019
Infrared Thermometer, Breeze model
K191283 · FLL
Suzhou Melodicare Medical Technology...
General Hospital · 158d
Cleared Oct 18, 2019
Pulse Oximeter
K191430 · DQA
Shenzhen Yimi Life-Technology Co., Ltd.
Anesthesiology · 142d
Cleared Oct 18, 2019
Saalio
K191436 · EGJ
Saalmann Medical GmbH & Co. KG
Physical Medicine · 141d
Cleared Oct 18, 2019
Synapse 3D Blood Flow Analysis
K191544 · LLZ
Fujifilm Corporation
Radiology · 129d
Cleared Oct 18, 2019
Infrared Forehead Thermometer (Model IR-FT)
K191668 · FLL
Comper Chuangxiang (Beijing)...
General Hospital · 119d
Cleared Oct 18, 2019
ATEC IOM Accessory Instruments
K191723 · PDQ
Alphatec Spine, Inc.
Neurology · 113d
Cleared Oct 18, 2019
SYMPHONY Navigation Ready Instruments, Universal Navigation Adaptor Set
K191943 · OLO
Medos International SARL
Orthopedic · 88d
Cleared Oct 18, 2019
Quantum Blood and Fluid Warming System
K192325 · LGZ
Life Warmer, Inc.
General Hospital · 52d
Cleared Oct 18, 2019
Confirm Rx Insertable Cardiac Monitor
K192593 · MXC
Abbott
Cardiovascular · 28d
Cleared Oct 18, 2019
Bashir S-B Endovascular Catheter, Ref. No. 7101
K192598 · QEY
Thrombolex, Inc.
Cardiovascular · 28d
Cleared Oct 18, 2019
NuVasive Modulus XLIF Interbody System
K192760 · MAX
Nu Vasive, Incorporated
Orthopedic · 18d
Cleared Oct 17, 2019
BcSs-PICNI-2000 Sensor
K182073 · GWM
Braincare Desenvolvimento E Inovacao...
Neurology · 442d
Cleared Oct 17, 2019
EasyMark Tissue Marker
K183503 · NEU
Inrad, Inc.
General & Plastic Surgery · 304d
Cleared Oct 17, 2019
DyeVert™ Plus Contrast Reduction System, DyeTect™ Contrast Monitoring System,...
K190102 · DXT
Osprey Medical, Inc.
General Hospital · 268d
Cleared Oct 17, 2019
SmartCeph
K190162 · LLZ
Ortho2, LLC
Radiology · 259d
Cleared Oct 17, 2019
Voxel Dosimetry™ v1.0
K191216 · LLZ
Hermes Medical Solutions AB
Radiology · 164d
Cleared Oct 17, 2019
Freestyle Flex
K191653 · HGX
Medela AG
Obstetrics & Gynecology · 119d
Cleared Oct 17, 2019
MT One Diamond
K191942 · GEX
M&T S.R.L.
General & Plastic Surgery · 87d
Cleared Oct 17, 2019
On Call Express II Blood Glucose Monitoring System
K192175 · NBW
ACON Laboratories, Inc.
Chemistry · 66d
Cleared Oct 17, 2019
WavelinQ Plus EndoAVF System
K192239 · PQK
C.R. Bard, Inc.
Cardiovascular · 59d
Cleared Oct 17, 2019
Matrix HA PEEK Cervical Implant System
K192316 · ODP
Sapphire Medical Group
Orthopedic · 52d
Cleared Oct 17, 2019
Arthrex SwiveLock Anchors
K192441 · MAI
Arthrex, Inc.
Orthopedic · 41d
Cleared Oct 17, 2019
Merge PACS
K192455 · LLZ
Merge Healthcare Incorporated
Radiology · 38d