Search FDA 510(k) Database

6,825 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
14713–14736 of 174,061
Cleared Aug 17, 2021
Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System
K203089 · QDK
Dexcom, Inc.
Chemistry · 308d
Cleared Aug 17, 2021
ASPIVIX v1.1 Cervical Suction Tenaculum
K203820 · HDC
Aspivix SA
Obstetrics & Gynecology · 231d
Cleared Aug 17, 2021
Deep Transcranial Magnetic Stimulation (DTMS) System
K210201 · OBP
Brainsway , Ltd.
Neurology · 204d
Cleared Aug 17, 2021
ROSA Hip System
K210998 · LLZ
Orthosoft D/B/A Zimmer Cas
Radiology · 137d
Cleared Aug 17, 2021
STARband
K211376 · OAN
Orthomerica Products, Inc.
Neurology · 105d
Cleared Aug 17, 2021
Journey II Mid-Level Tibial Inserts
K211671 · JWH
Smith & Nephew, Inc.
Orthopedic · 77d
Cleared Aug 17, 2021
Disposable Medical Nitrile Gloves
K211708 · LZA
Jiangsu Health-Peace Medical...
General Hospital · 75d
Cleared Aug 16, 2021
iMap 3D Mapping & Navigation System (iMap System)
K201094 · DQK
Cardionxt, Inc.
Cardiovascular · 479d
Cleared Aug 16, 2021
Metallic Fabric Electrodes
K202636 · GXY
Guangzhou Xinbo Electronic Co., Ltd.
Neurology · 339d
Cleared Aug 16, 2021
Rhino Health Non-Sterile, Powder-free Nitrile Exam Glove
K203236 · LZA
Rhino Health, Inc.
General Hospital · 286d
Cleared Aug 16, 2021
Disposable Monopolar Laparoscopic Shafts and Reusable Handles
K210569 · GEI
Dannik, LLC
General & Plastic Surgery · 171d
Cleared Aug 16, 2021
CPM Medical Consultants Tibial Revision Knee System
K210695 · JWH
Cpm Medical Consultants, LLC
Orthopedic · 161d
Cleared Aug 16, 2021
NuVent Eustachian Tube Dilation Balloon
K210841 · PNZ
Medtronic Xomed, Inc.
Ear, Nose, Throat · 147d
Cleared Aug 16, 2021
Multi-Link X2 ECG Cable and Leadwire System
K211294 · DSA
Vyaire Medical, Inc.
Cardiovascular · 110d
Cleared Aug 16, 2021
Penumbra System (Reperfusion Catheter RED 72)
K211654 · NRY
Penumbra, Inc.
Neurology · 80d
Cleared Aug 16, 2021
Insignia Hip Stem
K211703 · MEH
Stryker Orthopaedics
Orthopedic · 74d
Cleared Aug 16, 2021
Adena-Zina System
K212066 · NKB
Shanghai Sanyou Medical Co, Ltd.
Orthopedic · 45d
Cleared Aug 16, 2021
TruSPECT Radiological Image Processing Station
K212230 · LLZ
Spectrum Dynamics Medical, Ltd.
Radiology · 31d
Cleared Aug 14, 2021
I.V. Administration Set
K210381 · FPA
Bq Plus Medical Co., Ltd.
General Hospital · 186d
Cleared Aug 13, 2021
MEGA-TMS
K192823 · GWF
Soterix Medical, Inc.
Neurology · 681d
Cleared Aug 13, 2021
Clearblue® Early Digital Pregnancy Test
K200913 · LCX
Spd Swiss Precision Diagnostics GmbH
Chemistry · 494d
Cleared Aug 13, 2021
Insignis Subcutaneous Needle Sets
K202279 · FPA
Innovative Health Sciences, LLC
General Hospital · 367d
Cleared Aug 13, 2021
Nisus Touch Negative Pressure Wound Therapy Pump
K203693 · OMP
Cork Medical Products, LLC
General & Plastic Surgery · 238d
Cleared Aug 13, 2021
Tyber Medical Anatomical Plating System
K203817 · HRS
Tyber Medical, LLC
Orthopedic · 227d