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HARMONIC HD 1000I SHEARS 36CM SHAFT

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·May 25, 2023

Presage ST2 Assay, catalog numbers BC-1065 and BC-1065E. The Critical Diagnostics Presage ST2 Assay kit is an in vitro diagnostic device that quantitatively measures ST2 in serum or plasma by enzyme-linked immunosorbent assay (ELISA) in a microtiter plate format. The Presage ST2 Assay is indicated to be used in conjunction with clinical evaluation as an aid in assessing the prognosis of patients diagnosed with chronic heart failure.

FDA Recall
Terminated ·Critical Diagnostics·Product code OYG·February 28, 2012

Oy GE Healthcare Bio-Sciences Ab

Importer
🇫🇮 Finland·1 Manufacturer

St2 Assay

FDA classification
FDA Class 2 ·St2 Assay

HELKUEB OHG

Manufacturer
🇩🇪 Germany·1 Basic UDI-DI·1 Device·DNV MEDCERT GmbH

LFM-Diagnostika oHG

Manufacturer
🇩🇪 Germany

Rescue Trade OHG

Manufacturer
🇩🇪 Germany

CareLiv Produkte OHG

Manufacturer
🇩🇪 Germany

OTG Handels GmbH

Manufacturer
🇩🇪 Germany

BYG INFORMATIQUE

FDA registration
BYG INFORMATIQUE·1 product·🇫🇷 France

Sanitätshaus Förster Orthopädietechnik oHG

Manufacturer
🇩🇪 Germany

RESCUE TRADE OHG

FDA registration
RESCUE TRADE OHG·1 product·🇩🇪 Germany

Villinger OHG Physio- und Praxiseinrichtungen

Manufacturer
🇩🇪 Germany

METEK Köber & Michalski OHG

Manufacturer
🇩🇪 Germany·40 Basic UDI-DIs·43 Devices

3Shape Scan Bodies

FDA UDI
3shape Trios A/S·05902729751711·ANKYLOS - Regular platform - Connection: Ø7

Johnson-Promident

FDA UDI
Young Innovations, Inc.·00843471115596·HYGIENIST PLUS (5,500RPM)

Scissors Ong

FDA UDI
BLINK MEDICAL LIMITED·05060480407435·

OLG-100

FDA UDI
GTG Wellness Co., Ltd.·08809520341066·

OLG-200

FDA UDI
GTG Wellness Co., Ltd.·08809520341028·

OLG-200

FDA UDI
GTG Wellness Co., Ltd.·08809520341011·