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SAFE TRACE TX

FDA Adverse Event
Malfunction ·HAEMONETICS CORPORATION·Product code OYT·December 13, 2022

VYAIRE OY, T-PIECE NEONATAL PATIENT CIRCUIT KIT, DISPOSABLE

FDA Adverse Event
Malfunction ·MERCURY MEDICAL·Product code BTL·February 14, 2025

Amplilink (AL) Software 3.2.3 for use with COBAS AMPLICOR, CAP/CA, COBAS TaqMan,and COBAS AmpliPrep/COBAS TaqMan. The software can be used with a Laboratory Information System.

FDA Recall
Terminated ·Roche Molecular Systems, Inc.·Product code OYT·April 23, 2012

OPT SURGISYSTEMS

Manufacturer
🇮🇹 Italy

Out Of Srl

Manufacturer
🇮🇹 Italy

Elis Ost GmbH

Manufacturer
🇩🇪 Germany

OPT RETINA SL

Manufacturer
🇪🇸 Spain·2 Basic UDI-DIs·2 Devices

Out of Site Ltd

Manufacturer
1 Basic UDI-DI·308 Devices

MYT USA CORP

FDA registration
MYT USA CORP·1 product·🇺🇸 United States

HOYT MEDICAL LLC

FDA registration
HOYT MEDICAL LLC·1 product·🇺🇸 United States

Foshan Ost Medical Equipment Technology Co., LTD

Manufacturer
🇨🇳 China·3 Basic UDI-DIs·3 Devices

Bollé Brands

FDA UDI
BOLLE BRANDS (FRANCE)·00726644108161·

Bollé Brands

FDA UDI
BOLLE BRANDS (FRANCE)·00726644108178·

Medvat

FDA UDI
Myt Enterprises LLC·00850024089174·Medvat Multi Purpose Ultrasound Gel

Medvat

FDA UDI
Myt Enterprises LLC·00850024089518·Medvat Ultrasonic Gel with Aloe Vera 5-Liter 4-...

Medvat

FDA UDI
Myt Enterprises LLC·00850024089204·Medvat Ultrasonic Gel with Aloe Vera 20g 100-Pack

Medvat

FDA UDI
Myt Enterprises LLC·00850024089235·Conductive Gel

Medvat

FDA UDI
Myt Enterprises LLC·00850024089815·Medvat Ultrasonic Gel with Aloe Vera 8.5oz 2-Pack

OMNISCIENT NEUROTECHNOLOGY PTY LTD (O8T)

FDA registration
OMNISCIENT NEUROTECHNOLOGY PTY LTD (O8T)·1 product·🇦🇺 Australia

OATS GLOVES

Device
EU MDR · Eu Md Class 1 ·Hartalega NGC Sdn. Bhd.·On the market