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
9121–9144 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 25, 2023
EFAI RTSUITE CT HCAP-Segmentation System
K231928 · QKB
Ever Fortune.Ai, Co., Ltd.
Radiology · 87d
Cleared Sep 25, 2023
Virtue Male Sling System with Alexis Wound Retractor Convenience Kit
K231891 · OTM
Coloplast
Gastroenterology & Urology · 90d
Cleared Sep 25, 2023
BD Texium™ Needle-Free Syringe
K231888 · FMF
Care Fusion
General Hospital · 90d
Cleared Sep 25, 2023
Cervical Spine Truss System (CSTS)
K231739 · OVE
4Web Medical, Inc.
Orthopedic · 103d
Cleared Sep 25, 2023
TiLink-P SI Joint Fusion System
K230857 · OUR
SurGenTec, LLC
Orthopedic · 180d
Cleared Sep 25, 2023
Smileyscope System (Therapy Mode)
K230825 · QRA
Smileyscope Holding, Inc.
Physical Medicine · 185d
Cleared Sep 25, 2023
EndoCore
K230778 · KTI
Praxis Medical, LLC
Anesthesiology · 188d
Cleared Sep 25, 2023
Holter ECG and ABP System
K230184 · DSH
Edan Instruments, Inc.
Cardiovascular · 245d
Cleared Sep 25, 2023
Exactech Equinoxe PHx Fracture System
K223933 · HRS
Exactech, Inc.
Orthopedic · 269d
Cleared Sep 25, 2023
Self-Fitting hearing aids
K221052 · QUH
Huizhou Jinghao Medical Technology...
Ear, Nose, Throat · 532d
Cleared Sep 24, 2023
ADVIA Centaur® NT-proBNPII (PBNPII)
K220265 · NBC
Siemens Healthcare Diagnostics, Inc.
Chemistry · 601d
Cleared Sep 23, 2023
B.Light Clear Evo and B.Light Restore Evo
K223919 · OHS
Bemer Int AG
General & Plastic Surgery · 268d
Cleared Sep 23, 2023
Osstem Implant System
K222778 · DZE
Osstem Implant Co., Ltd.
Dental · 374d
Cleared Sep 22, 2023
DX. Bond V Dental Bonding Adhesive
K232978 · KLE
Sino-Dentex Co., Ltd.
Dental · 1d
Cleared Sep 22, 2023
CATHTONG™ II PICC Catheter
K232594 · LJS
L&Z Us, Inc.
General Hospital · 28d
Cleared Sep 22, 2023
CATHTONG™ II PICC Catheter
K232571 · LJS
L&Z Us, Inc.
General Hospital · 29d
Cleared Sep 22, 2023
UroLift 2 ATC Advanced Tissue Control System
K232558 · PEW
Neotract, Inc.
Gastroenterology & Urology · 30d
Cleared Sep 22, 2023
iLet® Dosing Decision Software
K232224 · QJI
Beta Bionics, Inc.
Chemistry · 57d
Cleared Sep 22, 2023
Electrically Power Wheelchairs (Models:YLB-W-0812-A01, YLB-W-0812-A02,...
K232193 · ITI
Yurob Rehabilitation Medical Co., Ltd.
Physical Medicine · 59d
Cleared Sep 22, 2023
IPL Hair Removal Device, Model(s): T1, T2, T3, T7, T10
K232183 · OHT
Shenzhen Koli Technology Co.,Ltd
General & Plastic Surgery · 60d
Cleared Sep 22, 2023
Annalise Enterprise CTB Triage Trauma
K231767 · QAS
Annalise-Ai Pty , Ltd.
Radiology · 98d
Cleared Sep 22, 2023
FemaSeed Intratubal Insemination
K231730 · MQF
Femasys, Inc.
Obstetrics & Gynecology · 101d
Cleared Sep 22, 2023
TriALTIS Spine System
K231479 · NKB
Medos International SARL
Orthopedic · 123d
Cleared Sep 22, 2023
Single-Use Latex Sterile Surgical Gloves (SG100)
K231446 · KGO
Fitone Latex Products Co., Ltd....
General Hospital · 127d