FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
16729–16752 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 21, 2021
AbutmentCAD
K193352 · PNP
Exocad GmbH
Dental · 595d
Cleared Jul 21, 2021
CHIRAVAC Blood Collection Needles
K201009 · JKA
Chirana T. Injecta
General Hospital · 460d
Cleared Jul 21, 2021
LifeSignals Multi-Parameter Remote Monitoring Platform
K202868 · DRG
Lifesignals, Inc.
Cardiovascular · 296d
Cleared Jul 21, 2021
Aduro light therapy Handheld
K203271 · OLP
Shenzhen Kaiyan Medical CO , Ltd.
General & Plastic Surgery · 257d
Cleared Jul 21, 2021
Surgical face mask (Model: Flat Ear Loop/CN102)
K203534 · FXX
Crown Name Disposable Hygiene...
General Hospital · 231d
Cleared Jul 21, 2021
Promisemed Insulin Pen Needle
K210059 · FMI
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 191d
Cleared Jul 21, 2021
Nitrile Patient Examination Glove
K210686 · LZA
Yunnan Huazhiyuan Medical Technology...
General Hospital · 135d
Cleared Jul 21, 2021
AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line...
K210688 · FYA
O&M Halyard, Inc.
General Hospital · 135d
Cleared Jul 21, 2021
Single-Use Surgical Mask Model FE2311B
K210970 · FXX
Byd Precison Manufacturer Co., Ltd.
General Hospital · 112d
Cleared Jul 21, 2021
Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System
K211223 · OTN
Boston Scientific Corporation
Gastroenterology & Urology · 89d
Cleared Jul 21, 2021
MolecuLightDX
K211901 · QJF
Moleculight, Inc.
General & Plastic Surgery · 30d
Cleared Jul 21, 2021
CD Horizon Spinal System
K211958 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 27d
Cleared Jul 20, 2021
LifeLens Wireless ECG Monitor
K203168 · DSH
LifeLens Technologies, Inc.
Cardiovascular · 270d
Cleared Jul 20, 2021
The Slide
K203712 · LQZ
Biotex, Inc.
Dental · 211d
Cleared Jul 20, 2021
ZIRKONZAHN.Implant-Planner, ZIRKONZAHN.Implant-Planner Practice, CAD/CAM STL...
K203765 · LLZ
Zirkonzahn Srl
Radiology · 209d
Cleared Jul 20, 2021
RF Thermal System
K210129 · PBX
Luvo Medical Technologies, Inc.
General & Plastic Surgery · 182d
Cleared Jul 20, 2021
TKO Composite Bite Turbo Gel
K210349 · EBF
Reliance Orthodontic Products, Inc.
Dental · 162d
Cleared Jul 20, 2021
Chest-CAD
K210666 · MYN
Imagen Technologies, Inc.
Radiology · 137d
Cleared Jul 20, 2021
Disposable Nitrile Medical Examination Glove
K210684 · LZA
Jiangsu Cureguard Glove Co., Ltd.
General Hospital · 134d
Cleared Jul 20, 2021
Change Healthcare Anatomical AI
K210719 · QIH
Change Healthcare Canada Company
Radiology · 132d
Cleared Jul 20, 2021
Grivamax Family of Lasers, Models 272 and 148
K211192 · OAP
Leana Orders, Inc.
General & Plastic Surgery · 90d
Cleared Jul 20, 2021
Elecsys Syphilis
K211302 · LIP
Roche Diagnostics
Microbiology · 82d
Cleared Jul 20, 2021
ACUSON Sequoia Diagnostic Ultrasound System
K211859 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 34d
Cleared Jul 20, 2021
Vital Signs
K211906 · QME
Oxehealth Limited
Cardiovascular · 29d