Search FDA 510(k) Database

6,792 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
13825–13848 of 174,061
Cleared Nov 26, 2021
ALTMS Magnetic Stimulation Therapy System
K202537 · OBP
Remed Co., Ltd.
Neurology · 451d
Cleared Nov 26, 2021
Medical surgical mask
K202842 · FXX
Henan Huibo Medical Co., Ltd.
General Hospital · 427d
Cleared Nov 26, 2021
Tablo Cartridge
K210782 · FJK
Outset Medical, Inc.
Gastroenterology & Urology · 255d
Cleared Nov 26, 2021
Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length...
K210833 · JOH
Smiths Medical Asd, Inc.
Anesthesiology · 252d
Cleared Nov 26, 2021
CUBE Air Purifier
K211139 · FRA
Samsung Electronics Co., Ltd.
General Hospital · 224d
Cleared Nov 26, 2021
MammoScreen 2.0
K211541 · QDQ
Therapixel
Radiology · 191d
Cleared Nov 26, 2021
Trevo Trak 21 Microcatheter
K211594 · QJP
Stryker Neurovascular
Neurology · 186d
Cleared Nov 26, 2021
Synthetic Nitrile Examination Gloves
K212488 · LYZ
Shandong Hongxin Chemicals Co., Ltd.
General Hospital · 109d
Cleared Nov 26, 2021
Nitrile Examination Gloves
K212722 · LZA
Wuhan Huirui Technology Co., Ltd.
General Hospital · 91d
Cleared Nov 24, 2021
Guiding Catheter
K210009 · DQY
CenterPoint Systems, LLC
Cardiovascular · 324d
Cleared Nov 24, 2021
Bronchoscope System
K211169 · EOQ
Shanghai AnQing Medical Instrument...
Ear, Nose, Throat · 219d
Cleared Nov 24, 2021
Surgical Mask (sterile)
K211295 · FXX
Nanjing 3h Medical Products Co., Ltd.
General Hospital · 210d
Cleared Nov 24, 2021
C-30 Crown Kit
K211345 · EBF
Perfect Fit Crowns, LLC
Dental · 205d
Cleared Nov 24, 2021
Regulora
K211463 · QMY
Metame Health, Inc.
Gastroenterology & Urology · 197d
Cleared Nov 24, 2021
The Radian MIS Bunion System
K211650 · HRS
Nvision Biomedical Technologies, Inc.
Orthopedic · 180d
Cleared Nov 24, 2021
Non-Contact Infrared Thermometer, model HL710H
K211744 · FLL
Health & Life Co., Ltd.
General Hospital · 170d
Cleared Nov 24, 2021
Trachealator
K211894 · KTI
Disa Medinotec
Ear, Nose, Throat · 156d
Cleared Nov 24, 2021
AMRA Profiler
K211983 · LNH
Amra Medical AB
Radiology · 152d
Cleared Nov 24, 2021
Atellica CH Enzymatic Creatinine_3 (ECre3)
K212223 · JFY
Siemens Healthcare Diagnostics, Inc.
Chemistry · 131d
Cleared Nov 24, 2021
MicroPen EVO
K212558 · QAI
Eclipse Medcorp, LLC
General & Plastic Surgery · 103d
Cleared Nov 24, 2021
Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown -...
K212633 · FYC
String King Lacrosse, LLC
General Hospital · 97d
Cleared Nov 24, 2021
Xpert Wrist
K213214 · HRS
Newclip Technics
Orthopedic · 56d
Cleared Nov 24, 2021
ControlRad Select Model Z
K213455 · OWB
Controlrad, Inc.
Radiology · 29d
Cleared Nov 23, 2021
Hystero-V Hysteroscope
K202445 · HIH
Hysterovue, Inc.
Obstetrics & Gynecology · 454d