Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartWare HVAD System

Duracetal

FDA 510(k)

FDA Class 2 ·Dental

YT-VT2024

FDA registration

Changsha Airdoc Health Technology Co., Ltd.·1 product·🇨🇳 China

fundus camera

FDA registration

Changsha Airdoc Health Technology Co., Ltd.·1 product·🇨🇳 China

Starlight Imaging Catheter

FDA registration

SPECTRAWAVE, INC.·4 products·🇺🇸 United States

ISOMEDIX OPERATIONS INC.

FDA registration

ISOMEDIX OPERATIONS INC.·4 products·🇺🇸 United States

ISOMEDIX OPERATIONS INC.

FDA registration

ISOMEDIX OPERATIONS INC.·4 products·🇺🇸 United States

Ergoline/AFFINITY 900 Advanced Performance, Soltron XL-85 WILDCAT

FDA UDI

JK-Products GmbH·EJKP100003268A0·

Ergoline Prestige 1600 Hybrid Performance

FDA UDI

JK-Products GmbH·EJKP100003549A0·

Ergoline/Prestige 1000 Intelligent Performance, Soltron XXL-115 STARLIGHT

FDA UDI

JK-Products GmbH·EJKP100003184A0·

Ergoline/Prestige 1400 Intelligent Performance, Soltron XXL-125 EAGLE

FDA UDI

JK-Products GmbH·EJKP100003192A0·

Planet Fitness 48/4

FDA UDI

JK-Products GmbH·EJKP100003420A0·

Encore/Encore Pro Data Management System

FDA registration

Philips Electronics Ltd·2 products·🇨🇦 Canada

FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEMS

FDA registration

FLEXICARE MEDICAL LTD.·2 products·🇬🇧 United Kingdom

Flexicare Heated Wire Breathing Systems

FDA registration

FLEXICARE MEDICAL (DONGGUAN) LTD.·2 products·🇨🇳 China

2026030, 2026035, 2026036, 2026030A, 2026031A

FDA registration

UAB INTERSURGICAL·2 products·🇱🇹 Lithuania

HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010

FDA registration

HAMILTON MEDICAL AG·2 products·🇨🇭 Switzerland

PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.

FDA registration

PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.·2 products·🇲🇽 Mexico

Flexicare Heated Wire Breathing Systems

FDA registration

FLEXICARE MEDICAL LTD.·2 products·🇬🇧 United Kingdom

Cover Plug for ID15

FDA registration

INT'AIR MEDICAL·2 products·🇫🇷 France