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
9913–9936 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 02, 2023
CPS Direct™ Universal slittable outer guide catheter (DS2C029)
K231311 · DQY
Abbott Medical
Cardiovascular · 28d
Cleared Jun 02, 2023
SCAR 3
K231309 · GEX
El.En Electroinc Engineering Spa
General & Plastic Surgery · 28d
Cleared Jun 02, 2023
APTUS® 3.5 TriLock Straight Plates
K230971 · HRS
Medartis AG
Orthopedic · 58d
Cleared Jun 02, 2023
Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS)...
K230952 · JWH
Howmedica Osteonics Corp., Dba...
Orthopedic · 59d
Cleared Jun 02, 2023
Anatomic PEEK™ Cervical Fusion System with Nanotechnology
K230936 · ODP
Nanovis, LLC
Orthopedic · 60d
Cleared Jun 02, 2023
Titanium Turbine
K230888 · EFB
Nakanishi, Inc.
Dental · 63d
Cleared Jun 02, 2023
Pen Needle
K230635 · FMI
Jiangsu Caina Medical Co.,Ltd
General Hospital · 87d
Cleared Jun 02, 2023
Huma RPM (RPM)
K230214 · MWI
Medopad, Inc.
Cardiovascular · 127d
Cleared Jun 02, 2023
ACTIVBRAID™
K223822 · GAT
Embody, Inc.
General & Plastic Surgery · 163d
Cleared Jun 02, 2023
Xpan Universal Trocar System
K223562 · GCJ
Xpan, Inc.
General & Plastic Surgery · 186d
Cleared Jun 02, 2023
CorNeat EverPatch
K223074 · QWU
Corneat Vision , Ltd.
Ophthalmic · 245d
Cleared Jun 02, 2023
Harvest Conceal ZR Block Out
K222961 · EIH
Harvest Dental Products, LLC
Dental · 248d
Cleared Jun 02, 2023
i3 ONE (203100-S)
K222727 · NHV
I3 Membrane GmbH
Gastroenterology & Urology · 267d
Cleared Jun 02, 2023
RGS
K222702 · FRA
Genesis Air, Inc.
General Hospital · 268d
Cleared Jun 02, 2023
Breathe+
K222018 · BWF
Peep Medical, LLC Dba Go2 Devices
Anesthesiology · 329d
Cleared Jun 02, 2023
ADVIA Centaur® Anti-Müllerian Hormone (AMH)
K221801 · PQO
Siemens Healthcare Diagnostics, Inc.
Toxicology · 346d
Cleared Jun 02, 2023
vWF Ag
K220728 · GGP
Siemens Healthcare Diagnostics...
Hematology · 445d
Cleared Jun 02, 2023
Volumat Line
K220301 · FPA
Fresenius Kabi
General Hospital · 485d
Cleared Jun 01, 2023
FiberTak® Suture Anchor
K231330 · MBI
Arthrex, Inc.
Orthopedic · 24d
Cleared Jun 01, 2023
cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems
K231306 · QQX
Roche Molecular Systems, Inc.
Microbiology · 27d
Cleared Jun 01, 2023
Drakon™ and Sequre® Microcatheters
K231293 · DQO
Accurate Medical Therapeutics
Cardiovascular · 28d
Cleared Jun 01, 2023
Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)
K230990 · GEX
Candela Corporation
General & Plastic Surgery · 56d
Cleared Jun 01, 2023
HardyDisk AST Rezafungin 5µg (RZF5)
K230827 · JTN
Hardy Diagnostics
Microbiology · 66d
Cleared Jun 01, 2023
Surgical Face Mask (L 175*95mm)
K230617 · FXX
Henan Chaoya Medical Equipment Co., Ltd.
General Hospital · 87d