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
6361–6384 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 09, 2024
aprevo® TLIF-C Articulating System
K241019 · MAX
Carlsmed
Orthopedic · 85d
Cleared Jul 09, 2024
Prima Plus Conical Implant System
K240966 · DZE
Keystone Dental, Inc.
Dental · 91d
Cleared Jul 09, 2024
deepLive
K240610 · NQQ
Damae Medical
General & Plastic Surgery · 126d
Cleared Jul 09, 2024
OW100S
K233937 · PZL
Softwave/Trt, LLC
General & Plastic Surgery · 208d
Cleared Jul 09, 2024
EM-07 Cordless Endo Motor
K232551 · EKX
Forum Engineering Technologies (96) ,...
Dental · 321d
Cleared Jul 08, 2024
LED Light Therapy Device, ELIXIR MD™
K241293 · GEX
Yassen Wellness, LLC
General & Plastic Surgery · 61d
Cleared Jul 08, 2024
da Vinci SP Surgical System (SP1098)
K240502 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 138d
Cleared Jul 08, 2024
RhythmStar System
K233584 · QYX
RhythMedix, LLC
Cardiovascular · 244d
Cleared Jul 05, 2024
SiOxD® Wound Matrix
K241660 · QSZ
Sioxmed, LLC
General & Plastic Surgery · 25d
Cleared Jul 05, 2024
DUO1 and DUO2
K241649 · MUH
Zinnovi, Inc.
Radiology · 28d
Cleared Jul 05, 2024
Anatase Navi Disposable Instrument
K241625 · OLO
Remex Medical Corp.
Orthopedic · 29d
Cleared Jul 05, 2024
LifeRay Intraoral Handheld X-ray System
K241305 · EHD
Lucas Lifecare
Radiology · 57d
Cleared Jul 05, 2024
AMT Suture Passer
K241111 · GCJ
Applied Medical Technology, Inc.
General & Plastic Surgery · 74d
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