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: 2026–2026 ×
1,922 results
385–408 of 1,922
Search insights Median review: 132d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Not Cleared Jun 18, 2026
Syncron-E
DEN250025 · QVC
Autonomous Healthcare, Inc.
Anesthesiology · 360d
Cleared Jun 17, 2026
twiist Automated Insulin Delivery (AID) System
K261672 · QFG
Deka Research and Development
Chemistry · 27d
Cleared Jun 17, 2026
Bonvadis®
K261638 · FRO
Oneness Biotech Co., Ltd.
General & Plastic Surgery · 30d
Cleared Jun 17, 2026
Amplatzer TorqVue Exchange System
K261631 · DQY
Abbott Medical
Cardiovascular · 30d
Cleared Jun 17, 2026
PICOSURE WORKSTATION
K261570 · GEX
Cynosure, LLC
General & Plastic Surgery · 36d
Cleared Jun 17, 2026
Hydro Irrigation System
K261544 · EOB
Stryker Instruments
Ear, Nose, Throat · 40d
Cleared Jun 17, 2026
FLEXI-PORT™ Power Injectable Implantable Port
K260916 · LJT
Portal Access, Inc.
General Hospital · 90d
Cleared Jun 17, 2026
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs...
K260867 · LZA
Hartalega NGC Sdn. Bhd.
General Hospital · 92d
Cleared Jun 17, 2026
Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D )
K260538 · HGX
Shenzhen Root Innovation Technology...
Obstetrics & Gynecology · 120d
Cleared Jun 17, 2026
RIVOS™ EUS Access Device (M00553900)
K260428 · ODG
Boston Scientific Corporation
Gastroenterology & Urology · 127d
Cleared Jun 17, 2026
INOSS System
K260006 · DZE
Inosys, Inc.
Dental · 166d
Cleared Jun 17, 2026
CoolSeal Generator® (CSL-200-90)
K253634 · GEI
Hologic, Inc.
General & Plastic Surgery · 210d
Cleared Jun 17, 2026
Assisted Reproduction Laser System (Model ILS-400M)
K253333 · MRX
Hua Yue Medical Technology Co., Ltd.
Obstetrics & Gynecology · 260d
Cleared Jun 17, 2026
Non-Sterile Ultrasound Gel Sterile Ultrasound Gel
K253255 · MUI
Foshan Pingchuang Medical Technology...
Radiology · 261d
Cleared Jun 17, 2026
Fule Metallic Lockable Intramedullary Nail Systems
K253155 · HSB
Beijing Fule Science & Technology...
Orthopedic · 264d
Cleared Jun 17, 2026
Sine Monitoring Parkinson’s Disease Tremor Dyskinesia Apple Watch (“SMPDTDAW”)
K253055 · GYD
Nordic Kinetics AB
Neurology · 268d
Cleared Jun 17, 2026
“Socko” Vimax Spinal Fixation System
K253045 · NKB
Socko Medical Co., Ltd.
Orthopedic · 268d
Cleared Jun 17, 2026
Portable Oxygen Concentrator
K252399 · CAW
Honsun (Nantong) Co., Ltd.
Anesthesiology · 321d
Cleared Jun 16, 2026
NEUROMARK System (NMK00301)
K261833 · GEI
Neurent Medical , Ltd.
Ear, Nose, Throat · 14d
Cleared Jun 16, 2026
Augment Off-Axis Instrument System
K261683 · PHX
Zimmer, Inc.
Orthopedic · 26d
Cleared Jun 16, 2026
I.T.S. Clavicle Plates with Angular Stability
K260958 · HRS
I.T.S. GmbH
Orthopedic · 85d
Cleared Jun 16, 2026
Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156,...
K260899 · OAP
Zdeer Technology (Henan) Co., Ltd.
General & Plastic Surgery · 90d
Cleared Jun 16, 2026
ACUSON Sequoia Diagnostic Ultrasound System
K260844 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 92d
Cleared Jun 16, 2026
Z1 Hip System
K260831 · LZO
Zimmer, Inc.
Orthopedic · 95d