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
5425–5448 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 25, 2024
LCD Monitors C310S, G310S, C316S, G316S, C616W
K243031 · PGY
Shenzhen Beacon Display Technology...
Radiology · 28d
Cleared Oct 25, 2024
Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W)
K243030 · OHT
Ulike Co., Ltd.
General & Plastic Surgery · 28d
Cleared Oct 25, 2024
BKS Revision System
K242984 · JWH
Ortho Development Corp.
Orthopedic · 29d
Cleared Oct 25, 2024
Pantera Pro
K242969 · LOX
Biotronik, Inc.
Cardiovascular · 29d
Cleared Oct 25, 2024
LDS Needle
K242956 · QNS
Ocuject, LLC
General Hospital · 30d
Cleared Oct 25, 2024
Freeze Point & Private Label Versions
K242625 · GEH
Cryoconcepts LP
General & Plastic Surgery · 52d
Cleared Oct 25, 2024
LYNX Photocoagulator
K242397 · HQF
Norlase Aps
Ophthalmic · 73d
Cleared Oct 25, 2024
QIAstat-Dx Respiratory Panel Mini
K242353 · QOF
QIAGEN GmbH
Microbiology · 78d
Cleared Oct 25, 2024
Neurophet AQUA (V3.1)
K242215 · QIH
Neurophet., Inc.
Radiology · 88d
Cleared Oct 25, 2024
CORGRIP* SR NG/NI Tube Retention System
K241185 · KNT
Avanos Medical, Inc.
Gastroenterology & Urology · 179d
Cleared Oct 25, 2024
Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV...
K240918 · LPL
Bruno Vision Care, LLC
Ophthalmic · 205d
Cleared Oct 25, 2024
Nitrile Powder Free Examination Gloves Biodegradable (Green)
K240269 · LZA
Comfort Rubber Gloves Industries Sdn....
General Hospital · 268d
Cleared Oct 25, 2024
FMT Disposable and Autoclavable Temperature Probes
K240223 · FLL
Metko Medikal VE Tibbi Cihazlar Dis...
General Hospital · 273d
Cleared Oct 25, 2024
Pulse Oximeter (YM101, YM102, YM103, YM104, YM201, YM301, YM202, YM302,...
K240092 · DQA
Shenzhen Yimi Life-Technology Co., Ltd.
Anesthesiology · 287d
Cleared Oct 25, 2024
VistaPano S Ceph 2.0 (VistaPano S Ceph)
K240040 · MUH
VATECH Co., Ltd.
Radiology · 294d
Cleared Oct 24, 2024
Manual Wheelchair (SYIV100-CA9221)
K242560 · IOR
Foshan Shunkangda Medical Tech Co., Ltd.
Physical Medicine · 57d
Cleared Oct 24, 2024
ROCC Console
K242512 · LLZ
Philips Medical Systems Nederland B.V.
Radiology · 62d
Cleared Oct 24, 2024
CEREC Cercon 4D CAD/CAM Blocks
K242462 · EIH
Dentsply Sirona
Dental · 66d
Cleared Oct 24, 2024
ArgenZ MTZ
K242458 · EIH
Argen Corporation
Dental · 66d
Cleared Oct 24, 2024
MagDI System (MAG-01, DS-01)
K242086 · SAH
Gt Metabolic Solutions, Inc.
General & Plastic Surgery · 99d
Cleared Oct 24, 2024
Duet External Drainage and Monitoring System (EDMS)
K242034 · PCB
Medtronic Neurosurgery
Neurology · 105d
Cleared Oct 24, 2024
Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)
K241554 · IYN
Telefield Medical Imaging (Shenzhen)...
Radiology · 146d
Cleared Oct 24, 2024
KeyPrint KeyDenture Base
K241089 · EBI
Keystone Industries
Dental · 188d
Cleared Oct 24, 2024
Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01)
K241007 · DXN
Shenzhen Urion Technology Co., Ltd.
Cardiovascular · 195d