510(k) Device Clearances

Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000)

Abbott

Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ (hexafocon A) Rigid Gas Permeable Contact Le

Acuity Polymers, Inc.

Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311

Guangzhou Berrcom Medical Device Co., Ltd.

LASSOSTAR NAV Circular Mapping Catheter

Biosense Webster, Inc.

VITA Akzent LC

Vita Zahnfabrik GmbH H Rauter & CO

Dozee VS

Turtle Shell Technologies Private Limited

TipTraQ (TTQ001)

Pranaq Pte. , Ltd.

Ziehm Vision FD

Ziehm Imaging GmbH

NovaLine SP-C35 Transducer Protector (956007)

Bain Medical Equipment (Guangzhou) Co., Ltd.

Swoop® Portable MR Imaging® System

Hyperfine, Inc.

UNO Negative Pressure Wound Therapy System

Genadyne Biotechnologies, Inc.

Surgical Face Mask

Xiantao Rayxin Medical Products Co., Ltd.

Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare

Yangzhou Fartley Medical Instrument Technology Co., Ltd.

BIOBRANE Temporary Wound Dressing; BIOBRANE Glove

Smith & Nephew Medical Limited

Disposable Medical Nitrile Examination Gloves (Non-Sterile)

Jiangsu Cherish Medical Technology Co., Ltd.

Primus Spinal Fixation System

Spinal Elements, Inc.

NeuroEars-Anna™

Neuroears, Inc.

Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH)

Shenzhen Ulike Smart Electronics Co., Ltd.

BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens

Shenzhen Dashicheng Optical Technology Co., Ltd.

syngo.via RT Image Suite

Siemens Medical Solutions USA, Inc.

Clarius Ejection Fraction AI

Clarius Mobile Health Corp.

HeRO Graft

Merit Medical Systems, Inc.

NeuroBlate Fusion-S Software V3.17

Monteris Medical,

Boston PICO (Boston PICO)

Boston Aesthetics, Inc.

EVOCLEAN CLEANsert Ultrasonic Insert

Ttbio Corp.

Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE)

Radiant Innovation, Inc.

Arctic Sun Temperature Management System (Model 5000)

Medivance, Inc.

TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)

Shenzhen Jiantuo Electronics Co., Ltd.

EndoTool IV (3.1)

Monarch Medical Technologies

ulrichINJECT CT motion

Ulrich GmbH & Co. KG