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
4297–4320 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 07, 2025
Flexible Video-Choledochoscope (CHV-110J-U)
K243535 · FBN
Shanghai SeeGen Photoelectric...
Gastroenterology & Urology · 112d
Cleared Mar 07, 2025
EpiWatch Monitoring System
K243515 · POS
Epiwatch, Inc.
Neurology · 114d
Cleared Mar 07, 2025
Lelo Hex Lubricated Natural Rubber Latex Condom
K243421 · HIS
Lelo, Inc.
Obstetrics & Gynecology · 123d
Cleared Mar 07, 2025
Op.n(TM) Navigation
K242914 · OLO
Ecential Robotics
Orthopedic · 164d
Cleared Mar 07, 2025
SPINEART Navigation Instrument System
K242890 · OLO
Spineart SA
Orthopedic · 165d
Cleared Mar 07, 2025
CuffTrek
K242642 · BSK
Shanghai Longmann Tech Co., Ltd.
Anesthesiology · 185d
Cleared Mar 07, 2025
Geistlich Bio-Flow®
K242510 · NPM
Geistlich Pharma AG
Dental · 196d
Cleared Mar 07, 2025
Apex Locator
K242383 · LQY
Shenzhen Rogin Medical Co., Ltd.
Dental · 207d
Cleared Mar 07, 2025
Cleerly LABS (v2.0)
K242338 · QIH
Cleerly, Inc.
Radiology · 212d
Cleared Mar 07, 2025
NOABLE LASER
K242207 · GEX
Daeju Meditech Engineering Co., Ltd.
General & Plastic Surgery · 221d
Cleared Mar 07, 2025
ATMOS C 051 Thorax (317.0200.0)
K241799 · BTA
Atmos Medizintechnik GmbH & Co. KG
General & Plastic Surgery · 259d
Cleared Mar 07, 2025
Handbike Batec Electric
K241159 · ITI
Batec Mobility, S.L.
Physical Medicine · 315d
Cleared Mar 06, 2025
BD Phoenix™ Automated Microbiology System
K250344 · LON
Becton, Dickinson and Company
Microbiology · 28d
Cleared Mar 06, 2025
Philips IntelliSite Pathology Solution 5.1
K243871 · PSY
Philips Medical Systems Nederland B.V.
Pathology · 79d
Cleared Mar 06, 2025
Intra-Operative Positioning System (IOPS®)
K243842 · DQK
Centerline Biomedical, Inc.
Cardiovascular · 83d
Cleared Mar 06, 2025
Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)
K243724 · JWH
Zimmer, Inc.
Orthopedic · 93d
Cleared Mar 06, 2025
PureLift GLOW
K243587 · NFO
Xtreem Pulse, LLC
Neurology · 106d
Cleared Mar 06, 2025
BEAR® (Bridge-Enhanced ACL Restoration) Implant
K243578 · QNI
Miach Orthopaedics, Inc.
Orthopedic · 107d
Cleared Mar 06, 2025
LVivo Seamless
K243331 · QIH
Dia Imaging Analysis, Ltd.
Radiology · 133d
Cleared Mar 06, 2025
Sterile Water USP and Sterile 0.9% Normal Saline USP
K243001 · FRO
Laboratorios Biogalenic S.A. DE C.V.
General & Plastic Surgery · 161d
Cleared Mar 06, 2025
XCELLARISPRO TWIST microneedling device
K241790 · QAI
Dermaroller GmbH
General & Plastic Surgery · 258d
Cleared Mar 06, 2025
Versacem Acetabular Shell and Double Mobility HC Liners
K241767 · LZO
Medacta International S.A.
Orthopedic · 259d
Cleared Mar 05, 2025
TITANEX Screw Systems
K250304 · HWC
Vilex, LLC
Orthopedic · 30d
Cleared Mar 05, 2025
Mako Total Hip Application 5.0
K243751 · OLO
Mako Surgical Corp.
Orthopedic · 90d