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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
14401–14424 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 10, 2021
Invictus Spinal Fixation System
K213460 · NKB
Alphatec Spine, Inc.
Orthopedic · 44d
Cleared Dec 10, 2021
NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar,...
K213543 · OBP
Neuronetics, Inc.
Neurology · 32d
Cleared Dec 10, 2021
JAZZ Solo sensor
K213637 · MUH
Jazz Imaging, LLC Dba Jazz Imaging
Radiology · 22d
Cleared Dec 10, 2021
Traveler 0.038 Stylet Portal Vein Access (TPS001), Traveler 21ga Needle...
K213638 · DYB
Argon Medical Devices
Cardiovascular · 22d
Cleared Dec 09, 2021
Infinity Acute Care System (IACS) Monitoring Solution
K201764 · MHX
Draeger Medical Systems, Inc.
Cardiovascular · 528d
Cleared Dec 09, 2021
AirStrip ONE Web Client with Alarm Communication Management (ACM)
K211949 · MSX
Airstrip Technologies, Inc.
Cardiovascular · 169d
Cleared Dec 09, 2021
LOSPA TKR System
K212034 · JWH
Corentec Co., Ltd.
Orthopedic · 163d
Cleared Dec 09, 2021
Plasma IQ
K212329 · GEI
Neauvia North America, Inc.
General & Plastic Surgery · 135d
Cleared Dec 09, 2021
LVivo Seamless
K212466 · QIH
Dia Imaging Analysis, Ltd.
Radiology · 125d
Cleared Dec 09, 2021
VOCO Retraction Paste
K213149 · MVL
Voco GmbH
Dental · 73d
Cleared Dec 09, 2021
SeaSpine WaveForm, C Interbody System
K213359 · OVE
SeaSpine Orthopedics Corporation
Orthopedic · 58d
Cleared Dec 09, 2021
Disposable Medical Nitrile Examination Gloves (Model:XYS-001)
K213371 · LZA
Anhui Xinyisheng Medical Technology...
General Hospital · 58d
Cleared Dec 09, 2021
Nextra CH Cannulated Hammertoe System
K213530 · HWC
Nextremity Solutions, Inc.
Orthopedic · 34d
Cleared Dec 08, 2021
C&B 5.0 Hybrid
K210817 · EBG
Arum Dentistry Co., Ltd.
Dental · 265d
Cleared Dec 08, 2021
MAF Guard
K211487 · FXX
Maf Clothing Pvt Ltd Unit-3
General Hospital · 209d
Cleared Dec 08, 2021
Infrared forehead thermometer LD-FT-100B
K211629 · FLL
Honsun (Nantong) Co., Ltd.
General Hospital · 195d
Cleared Dec 08, 2021
ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20
K211898 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 170d
Cleared Dec 08, 2021
ShurFit Lumbar Interbody System
K212075 · MAX
Precision Spine, Inc.
Orthopedic · 159d
Cleared Dec 08, 2021
Anteralign Spinal System with Titan nanoLOCK Surface Technology
K212524 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 119d
Cleared Dec 08, 2021
PicoLO Premium
K212573 · GEX
Laseroptek Co., Ltd.
General & Plastic Surgery · 114d
Cleared Dec 08, 2021
Disposable Medical Nitrile Examination Gloves (Non sterile)
K212639 · LZC
Jiangsu Nanfang Medical Co., Ltd.
General Hospital · 110d
Cleared Dec 08, 2021
Injectable Root Canal Bioceramic Sealer
K212983 · KIF
Beijing C-Root Dental Medical Devices...
Dental · 82d
Cleared Dec 08, 2021
BD Nano 2nd Gen Pen Needle
K213156 · FMI
Becton, Dickinson and Company
General Hospital · 79d
Cleared Dec 07, 2021
endomina system
K211309 · OCW
Endo Tools Therapeutics S.A.
Gastroenterology & Urology · 221d