510(k) Device Clearances

Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK, UI20 DB, UI20 RE, UI20

Shenzhen Ulike Smart Electronics Co., Ltd.

MINIMA S System

Lima Corporate S.P.A.

QSCHECK UISACR

Qstag, Inc.

Emprint Ablation System with Thermosphere Technology (Overall System Name); Emprint Ablation Generator (CAGEN1); Emprint

Medtronic, Inc.

Fast Warm - NX

Fujifilm Irvine Scientific

Fastplex™ BCR-ABL (p210) %IS digital PCR Kit

Suzhou Precigenome, Ltd. Co;

syngo Application Software

Siemens Medical Solutions USA, Inc.

ArteraAI Prostate

Artera, Inc.

Visualase MRI-Guided Laser Ablation System (SW 3.4)

Medtronic Navigation, Inc.

Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet

Promisemed Hangzhou Meditech Co., Ltd.

SIGNA Hero

Ge Healthcare (Ge Medical Systems, LLC)

Compass BDS Biliary Stent

Cook Ireland, Ltd.

G-CEM UNIVERSAL

GC America, Inc.

GEM Flex Coil 16-L Array, 1.5T Receive Only; GEM Flex Coil 16-M Array, 1.5T Receive Only; GEM Flex Coil 16-S Array, 1.5T

Shenzhen RF Tech Co., Ltd.

Clean Connecting Tube

Yangzhou Fartley Medical Instrument Technology Co., Ltd.

XeliteMed VertehighFix High Viscosity Spinal Bone Cement

Xelite Biomed , Ltd.

InbellaIgnite RF System

Inbella Medical, Inc.

Benchmark Intracranial Access System

Penumbra, Inc.

Neodent Implant System - Zirconia Implant System

Jjgc Industria E Comercio DE Materiais Dentarios S.A.

Nisus NPWT Canister 500-mL (CPC-500)

Cork Medical

LEDEX

Dentmate Technology Co. , Ltd.

Qorda QD1

Winix, Inc.

Wrist Blood Pressure Monitor, models AOJ-35A, AOJ-35B, AOJ-35C, AOJ-35D, AOJ-35E

Shenzhen AOJ Medical Technology Co., Ltd.

Powder free nitrile examination glove- black, non sterile

Hong Seng Gloves Sdn Bhd

Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw

Innovate Orthopaedics, Ltd.

Hand Trauma Screw System

Skeletal Dynamics, Inc.

OK Handpiece

Jaintek Co.,Ltd

FISIOWARM 7.0

Golden Star Srl

SwiftMR

Airs Medical, Inc.

MultiSure GK Link Blood Glucose and Ketone Monitoring System

Apex BioTechnology Corp.