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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
8137–8160 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 10, 2024
Centurion™ Vision System (Active Sentry™) (8065753057)
K233902 · HQC
Alcon Laboratories, Inc.
Ophthalmic · 30d
Cleared Jan 10, 2024
Axon Therapy
K233364 · QPL
Neuralace Medical, Inc.
Physical Medicine · 100d
Cleared Jan 10, 2024
Numen Coil Embolization System
K232955 · HCG
MicroPort NeuroTech (Shanghai) Co., Ltd.
Neurology · 111d
Cleared Jan 10, 2024
LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC)...
K232604 · LDJ
Hangzhou Laihe Biotech Co., Ltd.
Toxicology · 135d
Cleared Jan 09, 2024
1788 4K Camera System with Advanced Imaging Modality
K233327 · GCJ
Stryker Endoscopy
General & Plastic Surgery · 102d
Cleared Jan 09, 2024
Dental Cone-beam Computed Tomography
K232710 · OAS
Yian Medical Technology (Haining)...
Radiology · 126d
Cleared Jan 09, 2024
LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test...
K232597 · DJG
Hangzhou Laihe Biotech Co., Ltd.
Toxicology · 134d
Cleared Jan 09, 2024
GORE® PROPATEN® Vascular Graft
K232312 · DSY
W.L. Gore & Associates, Inc.
Cardiovascular · 160d
Cleared Jan 08, 2024
Electrosurgical Pads (GBS-Dm 1030ac, GBS-Db 1031ac, GBS-Dm 1030a, GBS-Db...
K233615 · GEI
Baisheng Medical Co., Ltd.
General & Plastic Surgery · 56d
Cleared Jan 08, 2024
InkSpace Imaging Small Body Array
K233444 · MOS
Inkspace Imaging, Inc.
Radiology · 81d
Cleared Jan 08, 2024
Electronic Muscle Stimulator (Model MP01)
K233035 · NGX
Shenzhen Hengbosi Industrial Co., Ltd.
Neurology · 105d
Cleared Jan 08, 2024
HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT*...
K232894 · FXX
Owens & Minor (O&M) Halyard, Inc.
General Hospital · 112d
Cleared Jan 08, 2024
LungQ v3.0.0
K232412 · JAK
Thirona BV
Radiology · 151d
Cleared Jan 08, 2024
Air Gap Fiber
K232106 · GEX
Wontech Co., Ltd.
General & Plastic Surgery · 178d
Cleared Jan 08, 2024
DASI Dimensions (V1.0)
K231324 · QIH
Dasi Simulations
Radiology · 245d
Cleared Jan 07, 2024
Lifetech Cardio Temporary Pacemaker
K232721 · DTE
Shenzhen Lifetech Cardio Medical...
Cardiovascular · 124d
Cleared Jan 07, 2024
Teleport XT Microcatheter
K231608 · DQY
OrbusNeich Medical (Shenzhen) Co., Ltd.
Cardiovascular · 219d
Cleared Jan 07, 2024
autoSCORE
K231068 · OMB
Holberg Eeg AS
Neurology · 268d
Cleared Jan 05, 2024
IPL Hair Removal Device (UI04 MK,UI04 BN,UI04 BU,UI04 CB,UI04 GY,UI04 LG,UI04...
K233679 · OHT
Shenzhen Ulike Smart Electronics Co.,...
General & Plastic Surgery · 50d
Cleared Jan 05, 2024
DESS Dental Smart Solutions
K233316 · NHA
Terrats Medical SL
Dental · 98d
Cleared Jan 05, 2024
NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and...
K233229 · NEZ
Anx Robotica Corporation
Gastroenterology & Urology · 99d
Cleared Jan 05, 2024
ENDOCOLLECT Specimen Retrieval Bag
K232519 · GCJ
Ximedica
General & Plastic Surgery · 140d
Cleared Jan 05, 2024
VEA Align
K231917 · QIH
Eos Imaging
Radiology · 190d
Cleared Jan 05, 2024
ArcherQA (V1.0)
K231273 · IYE
Wisdom Technologies., Inc.
Radiology · 248d