510(k) Device Clearances

EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100)

Ever Fortune.Ai, Co., Ltd.

EEA Circular Stapler with Tri-Staple Technology

Covidien

INTEGRE LIO

Quantel Medical

Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)

Liao Ning Shangwei Medical Products Co., Ltd.

Grappler Suture Anchor R3FLEX IOL System

Paragon 28, Inc.

qXR-Detect

Qure.Ai Technologies

REAL INTELLIGENCE CORI

Blue Belt Technologies, Inc.

Dermatac Drape

3M

Ziehm Vision FD

Ziehm Imaging GmbH

8MP Color LCD Displays C811W, C811WT, PA27 and PA27T

Shenzhen Beacon Display Technology Co., Ltd.

AirSculpt Body Contouring System (AIRS-1-SYS)

Cellmyx

Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0)

Pelvital USA, Inc.

ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340)

Boehringer Laboratories, LLC

Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11 Plus/X11 Super/X11 Senior/X11/E11/E11 Pro/E11 Plu

Sonoscape Medical Corp.

Zimed Distal Medial Tibial Plate and Screw System

Zimed Medikal

eco-x Series (eco-x, eco-x-s)

Hdx Will Corp.

ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)

Ulrich GmbH & Co. KG

Nitinol Enhanced Device (NED)

Embolization, Inc.

SOLIUS PRO UVB Light Panel

Solius Labs, Inc.

SIGNEX

Osteonic Co., Ltd.

ICHOR 14F Embolectomy System

Ichor

BE Plus PRO, Neurotravel LIGHT

Eb Neuro S.P.A.

ARIX Small Fragment System

Jeil Medical Corporation

Safe Secure Sterilization Pouches and Rolls

Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.

VITEK REVEAL GN AST Assay and VITEK REVEAL AST System

Specific Diagnostics, LLC

MONOFIX PGCL, knotless wound closure device

Samyang Holdings Corp., Ltd.

Spartan Center Wire

Spartan Micro, Inc.

Lancing System, Sterile Lancet for Single Use, Lancing Device

Shandong Lianfa Medical Plastic Products Co. , Ltd.

XBeam (v2)

Xstrahl, Ltd.

COGNiTiON™ Staple System

Ortho Solutions UK , Ltd.