510(k) Device Clearances
Medical devices cleared through the FDA's 510(k) premarket notification process. Substantially equivalent to existing devices.
15,000 total clearances
FluoroDose Varnish
Centrix, Inc.
GenBody COVID-19 Ag Home Test
Genbody.Inc.
Curapuls 670
Enraf-Nonius, B.V.
Medline Universal Grounding Pad
Medline Industries, Inc.
ScanNav Anatomy Peripheral Nerve Block
Intelligent Ultrasound Limited
Everion+ System
Biofourmis Singapore Pte., Ltd.
ReShape Calibration Tubes
Reshape Lifesciences
Dakota LP System
Precision Spine, Inc.
c1Trac
Zimmer Medizinsysteme GmbH
Distal Access Catheter
Guangzhou Easycess Medical Co.,Ltd
Lenire Tinnitus Treatment Device
Neuromod Devices Limited
Upper Arm Electronic Blood Pressure Monitor(Model FC-BP100,FC-BP101,FC-BP102,FC-BP110,FC-BP111,FC-BP112)
Shenzhen Finicare Co., Ltd.
SixFix Hexapod Fixator and Deformity Analysis and Correction Software (DACS)
Amdt Holdings, Inc.
TELIGEN System Peripheral Motor Nerve Stimulation Indications
Medos International SARL
Mobility Scooter (X-12, X-14, X-17)
Wuyi Aichi Industry and Trade Co., Ltd.
IPL sapphire ice cooling hair remove device
Shenzhen Desida Technology Co., Ltd.
IO Expandable Lumbar Interbody Fusion System
MiRus, LLC
OxyMinder
Bio-Med Devices, Inc.
Surgical Mask
Chongqing PA Xijia Biotechnology Co., Ltd.
HI-EMT MAGSHAPE
Beijing Sano Laser S&T Development Co.,Ltd
XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50
GEMSS HEALTHCARE CO., LTD.
Disposable Nitrile Examination Glove (Tested for use with Chemotherapy Drug)
Inner Mongolia Boming Medical Supplies Co., Ltd.
Wearable Breast Pump (Model:YD-1193,YD-1195,YD-1196,YD-1198,YD-1199;YD-1193S,YD-1195S,YD-1196S,YD-1198S,YD-1199S)
Zhejiang Carebao Co., Ltd.
PathLoc-TA Expandable Lumbar Cage System
L&K BIOMED Co., Ltd.
ARDO Bellis
Ardo Medical AG
RadianceTx Radionuclide Brachytherapy Source
Radiance Therapeutics, Inc.
GIA Stapler with Tri-Staple Technology
Covidien
Mobility Scooter (CL-Q3, CL-Q4)
Zhejiang Wei Ling New Energy Technology Co., Ltd.
QUADSENSE
Eventum Orthopaedics, Ltd.
Evolve Nitric Oxide Delivery System
Mallinckrodt Manufacturing, LLC
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