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
LELTEK Ultrasound Imaging System (Model: LU700 Series)
Leltek, Inc.
Anterior Spine Truss System-Stand Alone (ASTS-SA)
4Web Medical, Inc.
Unscented menstrual long applicator tampon; Unscented menstrual Compact Applicator Tampon; Unscented menstrual Cardboard
Unibeauty (Hubei) Technology Co., Ltd.
GraftGun Universal Graft Delivery System (GDS)
SurGenTec, LLC
Rhythm Express Remote Cardiac Monitoring System (RX-1 mini)
VivaQuant, Inc.
ACTIV Cap
Cleansite Medical, Inc.
neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cervical
Ht Medical D.B.A. Xenix Medical
OrthoEasy Pal; OrthoEasy Pal Long Neck
Bernhard Förster GmbH (Bernhard Foerster Ltd.)
KATANA Zirconia ONE For IMPLANT
Kuraray Noritake Dental, Inc.
HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE
O&M Halyard, Inc.
Pre-Sintered Zirconia Coloring Liquid
Chengdu Besmile Medical Technology Co., Ltd.
IDS-iSYS Free Testosterone
Immunodiagnostic Systems Limited
Velofix SA Cervical Cage
U&I Corporation
Dental Impression Material
Chemoment Materials Co.,Ltd
StimRouter Neuromodulation System
Bioness, Inc.
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Rmkh Glove (Cambodia) Co., Ltd.
Motor Handpiece and Control Unit (SDI10)
Saeshin Precision Co., Ltd.
Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, HA Minuteman G3 MIS Fusion Plate, HA Mi
Spinal Simplicity, LLC
Skin and Wound Cleanser
Winner Medical Co., Ltd.
Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact)
Hygea Medical Technology Co., Ltd.
Contour ProtégéAI+
Mim Software, Inc.
ABLATE-IQ
Neuwave Medical, Inc.
Catalyst EA Convertible Stemmed Shoulder
Catalyst Orthoscience, Inc.
Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5
Canon Medical Systems Corporation
SparkTM Clear Aligner System
Ormco Corporation
Pantheon Pedicle Screw and Iliac Bolt Fixation System
Pantheon Spinal
HF Surgery Generator 400KHZ
Richard Wolf Medical Instruments Corporation
Microvolume Luer Access Device
B.Braun Medical, Inc.
EARP Interbody System
Nvision Biomedical Technologies, Inc.
Clear Guide SCENERGY
Clear Guide Medical
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