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
Esperance pHLO Aspiration System
Phenox, Ltd.
TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite/A
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Disposable Cytology Brush (AF series)
Alton (Shanghai) Medical Instruments Co., Ltd.
Infrared Thermometer, Model: JKH-300, JKH-301, JKH-302, JKH-303, JKH-304
Jkh Health Co., Ltd.
Nitrile disposable examination gloves
Xingyu Medical Tech Co., Ltd.
AcQMap High Resolution Imaging and Mapping System
Acutus Medical, Inc.
Surgical Face Mask
Foshan Nanhai Plus Medical Co, Ltd.
Advantis Platform
Advantis Medical Imaging Single Member P.C.
Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)
Haemonetics Corporation
butterflyBVM
Compact Medical, Inc.
BLUEDIAMOND IMPLANT, Abutment Screw
Megagen Implant Co., Ltd.
Infusion Sets for Single Use
Jiangsu Suyun Medical Materials Co., Ltd.
Grappler Suture Anchor PCFD Tether System
Paragon 28, Inc.
SteriCUBE® Multiple Tray Sterilization Systems
Stericube, LLC
ORIO-Ti Intervertebral Body Fusion Cage System
Spinecraft, LLC
VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500)
Olympus Medical Systems Corporation
IV Administration Set
B.Braun Medical, Inc.
Break Wave
Sonomotion, Inc.
Pollogen STOP U Model UXV Device
Pollogen, Ltd.
IM/ST Fixture System
Guilin Fiteeth Medical Instrument Co., Ltd.
Retraction, CWM-910T, APOLEX Tite
Chungwoo Co., Ltd.
TEMA Elbow system - Line extension
Lima Corporate S.P.A.
iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console (UPN: M00503210)
Boston Scientific Corporation
Disposable Barrier Sleeves
Premium Plus (Dongguan) Limited
ONE Nitrile Condom
Global Protection Corp.
BriefCase
Aidoc Medical , Ltd.
Spine Auto Views
GE Medical Systems SCS
Annalise Enterprise CXR Triage Trauma
Annalise-Ai Pty , Ltd.
Swiss LthoClast Trilogy
E.M.S Electro Medical Systems S.A
ABL90 FLEX PLUS System
Radiometer Medicals Aps
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