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
9601–9624 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 10, 2023
Play&Joy InvisiLube Lubricant Capsule
K220646 · NUC
Innovemed Bio-Tech Co., Ltd.
Obstetrics & Gynecology · 493d
Cleared Jul 07, 2023
Cleo
K232011 · NJM
American Orthodontics
Dental · 1d
Cleared Jul 07, 2023
ProMIS™ Fixation System
K231844 · NKB
Premia Spine, Ltd.
Orthopedic · 15d
Cleared Jul 07, 2023
Spine CAMP™ (1.1)
K231668 · QIH
Medical Metrics, Inc.
Radiology · 30d
Cleared Jul 07, 2023
Electromagnetic Stimulator Device(Model EM Contouring and Tesla Duet)
K231318 · NGX
Beijing Adss Development Co., Ltd.
Physical Medicine · 60d
Cleared Jul 07, 2023
Overture Orthopaedics Patellofemoral System
K231253 · KRR
Overture Resurfacing, Inc.
Orthopedic · 67d
Cleared Jul 07, 2023
ANDORATE® Valve Kit
K230932 · OCX
Ga Health Company Limited
Gastroenterology & Urology · 95d
Cleared Jul 07, 2023
Complement Kit Cases
K230804 · KCT
JJGC Ind?stria e Com?rcio de...
General Hospital · 106d
Cleared Jul 07, 2023
Blood Collection Set, Blood Collection Set with Holder, Safety Blood...
K230080 · JKA
Yangzhou Medline Industry, Co., Ltd.
General Hospital · 177d
Cleared Jul 07, 2023
T3 Platform software
K223578 · PPW
Etiometry, Inc.
Cardiovascular · 219d
Cleared Jul 07, 2023
Bladder Scanner Model: BVT02
K223448 · IYO
Xuzhou Kaixin Electronic Instrument...
Radiology · 234d
Cleared Jul 07, 2023
Invia® Integrated Dressing
K223388 · OMP
Medela AG
General & Plastic Surgery · 242d
Cleared Jul 07, 2023
AeviceMD
K223382 · DSH
Aevice Health Pte. , Ltd.
Anesthesiology · 242d
Cleared Jul 07, 2023
IH Implant System
K222707 · DZE
Sewonmedix, Inc.
Dental · 303d
Cleared Jul 06, 2023
HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20)
K231568 · JTN
Hardy Diagnostics
Microbiology · 36d
Cleared Jul 06, 2023
Tyber Medical Pin and Wire System (various)
K231339 · HTY
Tyber Medical, LLC
Orthopedic · 59d
Cleared Jul 06, 2023
Laparoscope (21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA,...
K231003 · GCJ
Guangdong Optomedic Technologies, Inc.
General & Plastic Surgery · 90d
Cleared Jul 06, 2023
VYBE RF Electrosurgical System
K230968 · GEI
ShenB Co., Ltd.
General & Plastic Surgery · 92d
Cleared Jul 06, 2023
MyEllevate
K230510 · GAT
Cynosure, LLC
General & Plastic Surgery · 132d
Cleared Jul 06, 2023
Servo-air Lite Ventilator System
K230173 · MNT
Maquet Critical Care AB
Anesthesiology · 167d
Cleared Jul 06, 2023
VERTICALE® Triangular Fixation System
K223806 · NKB
Silony Medical GmbH
Orthopedic · 199d
Cleared Jul 06, 2023
Lumos 3DX
K223780 · EHD
3Dio
Radiology · 202d
Cleared Jul 06, 2023
Whitsundays Mask System
K223747 · BZD
Resmed Pty Ltd (Registration Number:...
Anesthesiology · 204d
Cleared Jul 06, 2023
SpinMedix Absorbable Fibrous Membrane
K222220 · OWW
Celestray Biotech Company, LLC.,
Orthopedic · 346d