Search FDA 510(k) Devices

6,160 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
5953–5976 of 174,061
Cleared May 15, 2024
Heuron ICH
K233247 · QAS
Heuron Co., Ltd.
Radiology · 230d
Cleared May 15, 2024
BruxZir® NOW SRC
K231940 · NHA
Prismatik Dentalcraft, Inc.
Dental · 320d
Cleared May 14, 2024
Aventus Clot Management System
K240426 · CAC
Inquis Medical
Cardiovascular · 91d
Cleared May 14, 2024
Electric Breast Pump (BRP-301)
K233913 · HGX
Aoj Health Technology Co., Ltd.
Obstetrics & Gynecology · 154d
Cleared May 14, 2024
BNLE Hydrophilic Jacketed Peripheral Guidewire
K232662 · DQX
Biomerics Nle
Cardiovascular · 257d
Cleared May 13, 2024
Healgen® Accurate Fentanyl Rapid Test Cassette (Urine)
K240949 · NGL
Healgen Scientific, LLC
Toxicology · 35d
Cleared May 13, 2024
REMEX-GR100
K240759 · EHD
Remedi Co., Ltd.
Radiology · 54d
Cleared May 13, 2024
1060nm laser body slimming machine
K240658 · PKT
Hebei JT Medical Co., Ltd.
General & Plastic Surgery · 66d
Cleared May 13, 2024
Brainomix 360 e-Lung
K233875 · JAK
Brainomix Limited
Radiology · 158d
Cleared May 13, 2024
MIM – Monte Carlo Dosimetry
K232862 · LLZ
Mim Software, Inc.
Radiology · 241d
Cleared May 13, 2024
Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with...
K232614 · LZA
Sri Trang Gloves (Thailand) Public...
General Hospital · 259d
Cleared May 13, 2024
Disposable Double Lumen Endobronchial Tube
K232529 · CBI
Shenzhen Insighters Medical...
Anesthesiology · 266d
Cleared May 13, 2024
BEAR 2 Body
K232242 · NFO
Foreo, Inc.
Neurology · 290d
Cleared May 10, 2024
Organic Cotton Tampon
K240708 · HEB
Suzhou Borage Medical Technology Co.,...
Obstetrics & Gynecology · 56d
Cleared May 10, 2024
SCARLET® AC-Ti
K240699 · OVE
Spineart SA
Orthopedic · 57d
Cleared May 10, 2024
Dochek® Multi-Drug Urine Test Dipcard Rx
K240698 · DJG
Guangzhou Decheng Biotechnology Co.,...
Toxicology · 57d
Cleared May 10, 2024
Access OV Monitor
K240479 · LTK
Beckman Coulter, Inc.
Immunology · 80d
Cleared May 10, 2024
Ureterorenoscope System
K240374 · FGB
Shenzhen HugeMed Medical Technical...
Gastroenterology & Urology · 93d
Cleared May 10, 2024
Bioceramic Root Repair Material (C-Root BP)
K240365 · KIF
Beijing C-Root Dental Medical Devices...
Dental · 94d
Cleared May 10, 2024
PillCam™ Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader...
K240276 · NEZ
Given Imaging Ltd. (D.B.A. Medtronic)
Gastroenterology & Urology · 100d
Cleared May 10, 2024
HyperSuture Extension Line
K234079 · GAT
Threadstone, LLC
General & Plastic Surgery · 140d
Cleared May 10, 2024
Oocyte Flushing & Retrieval Medium
K234023 · MQL
Gimbo Medical Technology Shenzhen...
Obstetrics & Gynecology · 142d
Cleared May 10, 2024
pureFLOW 402 (F00012067)
K233950 · KPO
Fresenius Medical Care Renal...
Gastroenterology & Urology · 148d
Cleared May 10, 2024
APERTO Lucent MRI System
K233629 · LNH
Fujifilm Healthcare Americas Corporation
Radiology · 179d