Search FDA 510(k) Database

6,836 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
14977–15000 of 174,061
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
Cleared Jul 19, 2021
Elos® Intramedullary Nailing System
K201147 · HSB
Intrauma S.P.A
Orthopedic · 446d
Cleared Jul 19, 2021
Evolve System with the T3 Applicator
K210877 · PBX
Inmode , Ltd.
General & Plastic Surgery · 117d
Cleared Jul 19, 2021
ENNOVATE Spinal System
K210963 · NKB
Aesculap Implant Systems, LLC
Orthopedic · 110d
Cleared Jul 19, 2021
xvision Spine system (XVS)
K211188 · SBF
Augmedics, Ltd.
Orthopedic · 90d
Cleared Jul 19, 2021
Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation...
K211291 · PGW
Fiagon GmbH
Ear, Nose, Throat · 82d
Cleared Jul 19, 2021
POLARSTEM Calcar Reamer Guide
K211548 · LZO
Smith & Nephew, Inc.
Orthopedic · 61d
Cleared Jul 19, 2021
Z-6 Atrioseptostomy Catheter
K211910 · DXF
NuMED, Inc.
Cardiovascular · 28d