510(k) Device Clearances

TD-7301 Spirometer (TD-7301)

Gostar Co., Ltd.

Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber (PT-OF-D-S); Laser Fiber (PT-OF-E

Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.

Allure Hip Stem and Intramedullary Plugs

Waldemar Link GmbH & Co. KG

SterileRight sterilization pouch and roll

Sterileright Packaging Mfg., Inc.

Surgical Power System

Guizhou Zirui Technology Co., Ltd.

SnapHammer Hammertoe Correction System

Nvision Biomedical Technologies, Inc.

Spencer Probe Depth Electrodes

Ad-Tech Medical Instrument Corporation

The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug

Thermo Fisher Scientific

OpenTex

Purgo Biologics, Inc.

Infusion Sets for Single Use with Needles

Sichuan Prius Biotechnology Co., Ltd.

Z1 Hip System

Zimmer, Inc.

ACHIEVE Partial Knee System

Ignite Orthomotion

SICtapered & SICvantage tapered

Sic Invent AG

X-Guide Surgical Navigation System

X-Nav Technologies, LLC

Ampa One System (AMPA-001)

Neuromodulatory Devices & Applications

MONTAGE-QS Settable, Resorbable Bone Putty

Orthocon, Inc.

Elemental Granulate

Zinkh NV

Spectrum-2

Neko Health AB

Pelvic Muscle Trainer (KM510, KM516B)

Shenzhen Konmed Technology Co., Ltd.

Control-IQ+ technology

Tandem Diabetes Care, Inc.

Xpert Xpress CoV-2/Flu plus

Cepheid®

Disposable Prophy Angle

Pacific Care Limited

Spartan SC 069

Spartan Micro, Inc.

SyMRI

Syntheticmr AB (Publ.)

Elegant™ Advanced CompHort

Viramal Limited

XACT Robotic System, ACE Model

Xact Robotics, Ltd.

Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)

Shenzhen Med-Link Electronics Tech Co., Ltd.

Introducer Sheath Kits

Beijing Demax Medical Technology Co.,Ltd

Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder System

Stryker Corporation (Tornier, Inc.)

StarFin

Premium Medical Technology, LLC