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
13249–13272 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 17, 2022
ARIA Radiation Therapy Management (v16.1 MR3)
K221408 · IYE
Varian Medical Systems, Inc.
Radiology · 32d
Cleared Jun 17, 2022
ElucidVivo A.3
K221463 · LLZ
Elucid Bioimaging, Inc.
Radiology · 29d
Cleared Jun 17, 2022
Baby Gorilla/Gorilla Plating System
K221465 · HRS
Paragon 28, Inc.
Orthopedic · 29d
Cleared Jun 17, 2022
Langston dual lumen catheter
K221470 · DQO
Vascular Solutions, LLC
Cardiovascular · 28d
Cleared Jun 16, 2022
FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System
K201037 · NBW
Taidoc Technology Corporation
Chemistry · 787d
Cleared Jun 16, 2022
DePuy 3D Additive TriFlange Acetabular Cup
K201348 · LPH
Depuy International, Ltd.
Orthopedic · 756d
Cleared Jun 16, 2022
Custom-made Invisible Aligners
K203624 · NXC
Zhejiang Yinchili Medical Technology...
Dental · 552d
Cleared Jun 16, 2022
Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and without...
K212426 · MQL
Donnevie Medical Technology...
Obstetrics & Gynecology · 316d
Cleared Jun 16, 2022
Seer Home
K212788 · GWQ
Seer Medical Pty, Ltd.
Neurology · 288d
Cleared Jun 16, 2022
TLC Unicompartmental Knee System
K212870 · HSX
Signature Orthopaedics Pty, Ltd.
Orthopedic · 280d
Cleared Jun 16, 2022
Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea...
K213504 · JAK
Canon Medical Systems Corporation
Radiology · 227d
Cleared Jun 16, 2022
Ion Endoluminal System (IF1000)
K220299 · EOQ
Intuitive Surgical, Inc.
Ear, Nose, Throat · 134d
Cleared Jun 16, 2022
WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible...
K220399 · EOQ
OTU Medical, Inc.
Ear, Nose, Throat · 125d
Cleared Jun 16, 2022
Dentis s-Clean Abutment Mini
K220440 · NHA
Dentis Co., Ltd.
Dental · 120d
Cleared Jun 16, 2022
Disposable Vinyl Examination Glove
K220469 · LYZ
Chifeng Huawei Medical...
General Hospital · 118d
Cleared Jun 16, 2022
Straumann TLX Variobase C
K220878 · NHA
Institut Straumann AG
Dental · 83d
Cleared Jun 16, 2022
TC Gloves
K221186 · LZA
Thanh Cong Pharmaceutical and Trading...
General Hospital · 52d
Cleared Jun 16, 2022
1st Glove Blue Nitrile Examination Gloves Powder Free
K221226 · LZA
Koove Iot Pvt. , Ltd.
General Hospital · 49d
Cleared Jun 16, 2022
Wireless Digital Flat Panel Detector
K221345 · MQB
Iray Technology Taicang , Ltd.
Radiology · 38d
Cleared Jun 15, 2022
EEG-acp
K212325 · GYB
Somnomedics GmbH
Neurology · 324d
Cleared Jun 15, 2022
ZQuiet Advance
K213088 · LRK
Sleeping Well, LLC
Dental · 264d
Cleared Jun 15, 2022
VITROS AFP
K213626 · LOJ
Ortho-Clinical Diagnostics
Immunology · 210d
Cleared Jun 15, 2022
SurgiCase Viewer
K213684 · LLZ
Materialise NV
Radiology · 205d
Cleared Jun 15, 2022
QardioArm 2
K220106 · DXN
Qardio, Inc.
Cardiovascular · 154d