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
6385–6408 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 03, 2024
VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500)
K241371 · FET
Olympus Medical Systems Corporation
Obstetrics & Gynecology · 49d
Cleared Jul 03, 2024
da Vinci Surgical System (IS5000)
K241284 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 57d
Cleared Jul 03, 2024
OSSIOfiber® Threaded Trimmable Fixation Nail
K241277 · HWC
OSSIO , Ltd.
Orthopedic · 58d
Cleared Jul 03, 2024
Upper Arm Electronic Blood Pressure Monitor
K241129 · DXN
Shenzhen Goodlymed Technology Co., Ltd.
Cardiovascular · 70d
Cleared Jul 03, 2024
Access Thyroglobulin Antibody II
K240996 · JNL
Beckman Coulter, Inc.
Immunology · 83d
Cleared Jul 03, 2024
Access sTfR
K240987 · DDG
Beckman Coulter, Inc.
Immunology · 84d
Cleared Jul 03, 2024
Gastric Alimetry
K240946 · MYE
Alimetry , Ltd.
Gastroenterology & Urology · 89d
Cleared Jul 03, 2024
Disposable Enteral Feeding Sets
K240052 · PIF
Beijing L&Z Medical Technology...
Gastroenterology & Urology · 177d
Cleared Jul 03, 2024
iQFlex Pro
K240009 · IZL
First Source, Inc.
Radiology · 183d
Cleared Jul 03, 2024
Total Wrist Arthroplasty System (TWA)
K233574 · JWJ
Skeletal Dynamics
Orthopedic · 239d
Cleared Jul 02, 2024
Extended Reservoir
K241622 · LZG
Medtronic Minimed
Chemistry · 27d
Cleared Jul 02, 2024
iFuse TORQ® Implant System
K241574 · OUR
SI-BONE, Inc.
Orthopedic · 29d
Cleared Jul 02, 2024
Fogarty Fortis Arterial Embolectomy Catheter
K241330 · DXE
Edwards Lifesciences
Cardiovascular · 53d
Cleared Jul 02, 2024
ViewPoint 6
K241300 · LLZ
Ge Healthcare GmbH
Radiology · 54d
Cleared Jul 02, 2024
Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55...
K240930 · LZA
Sri Trang Gloves (Thailand) Public...
General Hospital · 89d
Cleared Jul 02, 2024
ZIEN IO Intraosseous Access System
K240915 · FMI
Zien Medical Technologies, Inc.
General Hospital · 90d
Cleared Jul 02, 2024
Freedom® Total Knee System
K240863 · JWH
Maxx Orthopedics, Inc.
Orthopedic · 96d
Cleared Jul 02, 2024
SMART Bun-Yo-Matic X-Ray
K240736 · QIH
Disior, Ltd.
Radiology · 106d
Cleared Jul 02, 2024
Ultrasonic Scaler...
K240707 · ELC
Shenzhen Micro Electric Intelligence...
Dental · 109d
Cleared Jul 02, 2024
Tyto Insights for Crackles Detection
K240555 · PHZ
Tyto Care , Ltd.
Anesthesiology · 125d
Cleared Jul 02, 2024
Next Generation Aspiration Catheter
K234083 · NRY
Balt USA, LLC
Neurology · 193d
Cleared Jul 02, 2024
Next Generation Access Catheter
K234074 · QJP
Balt USA, LLC
Neurology · 193d
Cleared Jul 02, 2024
AOS Marker Seeds (SMG0242-025)
K233626 · JAQ
Alpha-Omega Services, Inc.
Radiology · 232d
Cleared Jul 02, 2024
Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal...
K233440 · HGM
Philips Medizin Systeme Boeblingen GmbH
Obstetrics & Gynecology · 258d