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
24097–24120 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 19, 2018
MAGNETOM Vida
K181433 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 140d
Cleared Oct 19, 2018
Stable-C Interbody System
K181621 · OVE
Nexus Spine, LLC
Orthopedic · 121d
Cleared Oct 19, 2018
ICONN Revolution Knotless Suture Anchor
K182264 · MBI
Iconn Orthopedics, LLC
Orthopedic · 59d
Cleared Oct 19, 2018
Vantage Orian 1.5T, MRT-1550, V4.5
K182282 · LNH
Canon Medical Systems Corporation
Radiology · 57d
Cleared Oct 19, 2018
Vivid S60N, Vivid S70N
K182450 · IYN
GE Medical Systems Ultrasound and...
Radiology · 42d
Cleared Oct 19, 2018
UroNav (Version 3.0)
K182561 · LLZ
Invivo Corporation
Radiology · 31d
Cleared Oct 19, 2018
DLP Aortic Root Cannula, DLP Aortic Root Cannula with Vent Line, DLP Pressure...
K182586 · DWF
Medtronic, Inc.
Cardiovascular · 29d
Cleared Oct 19, 2018
1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA, 1.5T 30ch AIR AA
K182590 · MOS
Ge Healthcare
Radiology · 29d
Cleared Oct 19, 2018
EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping...
K182644 · DQK
Abbott
Cardiovascular · 25d
Cleared Oct 19, 2018
Paragonix SherpaPak Cardiac Transport System
K182735 · MSB
Paragonix Technologies
Gastroenterology & Urology · 21d
Cleared Oct 18, 2018
TNI softFlow 50
K180474 · BTT
Tni Medical AG
Anesthesiology · 238d
Cleared Oct 18, 2018
Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit...
K180708 · PIF
Xeridiem Medical Devices, A Spectrum...
Gastroenterology & Urology · 213d
Cleared Oct 18, 2018
Extended Lipid Panel Assay
K181373 · CHH
Laboratory Corporation of America...
Chemistry · 147d
Cleared Oct 18, 2018
Reprocessed Torqr Diagnostic EP Catheter
K181618 · NLH
Innovative Health, LLC
Cardiovascular · 121d
Cleared Oct 18, 2018
BD FlowSmart Set/MiniMed Pro-Set
K181718 · FPA
Becton, Dickinson and Company
General Hospital · 111d
Cleared Oct 18, 2018
Medax Biopsy Systems III
K181803 · KNW
Medax Srl Unipersonale
General & Plastic Surgery · 105d
Cleared Oct 18, 2018
Swift System
K181941 · NEY
Emblation , Ltd.
General & Plastic Surgery · 90d
Cleared Oct 18, 2018
Quantum Ventilation Module
K181942 · DTX
Spectrum Medical , Ltd.
Cardiovascular · 90d
Cleared Oct 18, 2018
QuickScreen Pro Multi Drug Screening Test, Model 9395Z
K181945 · DKZ
Phamatech, Inc.
Toxicology · 90d
Cleared Oct 18, 2018
OLYMPIC Posterior Spinal Fixation System
K182239 · NKB
Astura Medical, LLC
Orthopedic · 59d
Cleared Oct 18, 2018
14HK701G-W
K182348 · MQB
Lg Electronics.Inc
Radiology · 50d
Cleared Oct 18, 2018
Spectralis HRA+OCT and variants with High Magnification Module
K182569 · OBO
Heidelberg Engineering GmbH
Ophthalmic · 30d
Cleared Oct 18, 2018
RadiForce RX360, RX360-AR
K182591 · PGY
Eizo Corporation
Radiology · 28d
Cleared Oct 17, 2018
ELAN 4 Electro Motor System Tools
K172709 · HBE
Aesculap, Inc.
Neurology · 404d