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
8641–8664 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 17, 2023
Lumen 155-SF
K223911 · QDD
Intricon Corporation
Ear, Nose, Throat · 292d
Cleared Oct 17, 2023
ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood)
K222214 · FXY
Thi Total Healthcare Innovation GmbH
General Hospital · 449d
Cleared Oct 16, 2023
ANDORATE® Valve Kit
K232118 · ODC
Ga Health Company Limited
Gastroenterology & Urology · 91d
Cleared Oct 16, 2023
Iontophoresis Electrodes
K232020 · EGJ
Top-Rank Health Care Co., Ltd.
Physical Medicine · 101d
Cleared Oct 16, 2023
Laparoscope (4KA0, 4KA0R, 4KA30, 4KA30R, 4KA45, 4KA45R)
K231725 · GCJ
Hunan Endoso Life Technology Co., Ltd.
General & Plastic Surgery · 125d
Cleared Oct 16, 2023
Willow Generation 3 Breast Pump
K230570 · HGX
Willow Innovations, Inc.
Obstetrics & Gynecology · 229d
Cleared Oct 16, 2023
Ikshana
K230249 · LLZ
Immersivetouch
Radiology · 259d
Cleared Oct 16, 2023
Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL
K230104 · DZE
Anthogyr
Dental · 276d
Cleared Oct 14, 2023
Infrared Thermometer (AOJ-20A)
K232128 · FLL
Shenzhen AOJ Medical Technology Co.,...
General Hospital · 89d
Cleared Oct 13, 2023
Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system),...
K232822 · ODP
Gbs Commonwealth Co., Ltd.
Orthopedic · 30d
Cleared Oct 13, 2023
Calibrate CCX Interbody System
K232504 · MAX
Alphatec Spine, Inc.
Orthopedic · 56d
Cleared Oct 13, 2023
RIGEL™ 3DR Anterior Cervical Corpectomy System
K232481 · PLR
MiRus, LLC
Orthopedic · 58d
Cleared Oct 13, 2023
Paragon 8F Balloon Guide Catheter
K232437 · DQY
Wallaby Medical
Neurology · 60d
Cleared Oct 13, 2023
Titan Dental Design
K232429 · PNN
Clearadvance, LLC
Dental · 63d
Cleared Oct 13, 2023
VyLink™ Spinal Screw System
K231744 · NKB
Vy Spine, LLC
Orthopedic · 121d
Cleared Oct 13, 2023
S1
K231672 · NPM
Medpark Co., Ltd.
Dental · 127d
Cleared Oct 13, 2023
Veuron-Brain-pAb3
K231642 · LLZ
Heuron Co., Ltd.
Radiology · 130d
Cleared Oct 13, 2023
The Evolve System with the Transform Applicator
K231495 · GEI
Inmode , Ltd.
General & Plastic Surgery · 143d
Cleared Oct 13, 2023
Macro & Micro-Test HCG Pregnancy Test Midstream
K230741 · LCX
Jiangsu Macro & Micro-Test Med-Tech...
Chemistry · 210d
Cleared Oct 13, 2023
Serena Sleep Night Guard
K230495 · MQC
Meris Investment Group
Dental · 232d
Cleared Oct 13, 2023
Xpert® Xpress CoV-2 plus
K230440 · QQX
Cepheid
Microbiology · 234d
Cleared Oct 13, 2023
SpotLight/SpotLight Duo (with DLIR option)
K230370 · JAK
Arineta , Ltd.
Radiology · 245d
Cleared Oct 13, 2023
Neuroblade System
K230125 · GWG
Clearmind Biomedical
Neurology · 269d
Cleared Oct 13, 2023
BONHAWA Respiratory Humidifier
K223863 · BTT
Telesair, Inc.
Anesthesiology · 294d