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
6649–6672 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 05, 2024
UniCel DxH 900 Coulter Cellular Analysis System
K240252 · GKZ
Beckman Coulter, Inc.
Hematology · 157d
Cleared Jul 05, 2024
Merlexi Craft Bariatric series of manual wheelchairs
K240120 · IOR
Turbo Wheelchair Co., Inc.
Physical Medicine · 171d
Cleared Jul 05, 2024
STERRAD™ Chemical Indicator (CI) Strip (14100)
K234084 · JOJ
Advanced Sterilization Products, Inc.
General Hospital · 196d
Cleared Jul 05, 2024
STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104)
K234082 · MLR
Advanced Sterilization Products
General Hospital · 196d
Cleared Jul 03, 2024
ECHELON 3000 45mm Compact Stapler (ECH45C)
K241629 · GAG
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 27d
Cleared Jul 03, 2024
Transducer Probe Cover
K241615 · ITX
Hony Medical Co., Ltd.
Radiology · 28d
Cleared Jul 03, 2024
Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120)
K241606 · NLQ
Stryker Sustainability Solutions
General & Plastic Surgery · 29d
Cleared Jul 03, 2024
Dermablate
K241600 · GEX
Asclepion Laser Technologies GmbH
General & Plastic Surgery · 29d
Cleared Jul 03, 2024
Blue Eye
K241591 · PLL
The Standard Co., Ltd.
Gastroenterology & Urology · 30d
Cleared Jul 03, 2024
Iconix® Anchor
K241577 · MBI
Riverpoint Medical
Orthopedic · 30d
Cleared Jul 03, 2024
SKOUT® system
K241508 · QNP
Iterative Scopes, Inc.
Gastroenterology & Urology · 36d
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