510(k) Device Clearances

SKAN C PULSAR

Skanray Technologies Limited

Visera Hysterovideoscope Olympus HYF Type V

Olympus Medical Systems Corporation

BabySat 3

Owlet Babycare, Inc.

Nooance Led And Laser Helmet

Shenzhen Kaiyan Medical Equipment Co., Ltd.

Branchor X Balloon Guide Catheter

Asahi Intecc Co., Ltd.

Cranial 4Pi Immobilization

Brainlab AG

SOUNDSTAR™ CRYSTAL Ultrasound Catheter

Biosense Webster, Inc.

Eleganz Fusion Screw System (Fusion Screw System)

Dev4

Drug Relief v1

Dyansys, Inc.

ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Ca

Acist Medical Systems, Inc.

Cortium™

Ulrich Medical USA

Pre-Formed Silicone Block

International Medical Devices, Inc.

TransLoc 3D

Foundation Fusion Solutions, LLC (Dba Cornerloc)

HOTWIRE™ RF Guidewire

Atraverse Medical

MIS LYNX Conical Connection Implant System

Dentsply Sirona, Inc.

Verisafe Safety Retractable Insulin Syringes

Promisemed Hangzhou Meditech Co., Ltd.

Constellation (CON-001)

Q Bio, Inc.

Bunkerhill MAC

BunkerHill Health

Sonosite PX Ultrasound System

FUJIFILM Sonosite, Inc.

VITEK 2 AST-Gram Negative Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN

Biomerieux Sa, Inc.

Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safet

Hh Global Technology, Inc.

ProCinch, QuadCinch

Riverpoint Medical

ENDOFLATOR +

Karl Storz SE & CO. KG

ZeTTA PACS

Tae Young Soft Co., Ltd.

Single-use Flexible Rhinolaryngoscope; Digital Video Monitor

Hunan Vathin Medical Instrument Co., Ltd.

LifeShield™ Infusion Safety Software Suite

Icu Medical, Inc.

Caregiver-assisted wheelchair (MS02);Caregiver-assisted wheelchair (MA02)

GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd.

DePuy Synthes MatrixSTERNUM Fixation System

Synthes GmbH

EMPHASYS Femoral Stems

Depuy Ireland UC

Elucid PlaqueIQ

Elucid Bioimaging, Inc.