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PAQ.215X280X200/QT-HS/Q-4500

FDA UDI
AB MEDICA GROUP, S.A.·08428763042051·

OFF SET DOUBLE CLAMP BAR

FDA Adverse Event
Malfunction ·ZIMMER ORTHO SURGICAL PRODUCTS·Product code HSQ·March 5, 2002

ZIMMER

FDA Adverse Event
Malfunction ·ZIMMER, INC.·Product code HSQ·March 19, 2001

OFFSET DOUBLE CLAMP BAR

FDA Adverse Event
Injury ·ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS·Product code HSQ·August 23, 2005

PANEL CLAMP UPPER AND LOWER

FDA Adverse Event
Malfunction ·ZIMMER PATIENT CARE·Product code HSQ·April 6, 2001

ZIMMER TRAPEZE

FDA Adverse Event
Malfunction ·ZIMMER PATIENT CARE·Product code HSQ·May 23, 2001

ZIMMER CLAMP ASSEMBLY

FDA Adverse Event
Other ·ZIMMER PATIENT CARE·Product code HSQ·April 24, 2001

Alinity h Interface Module (HSQ)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: FLX-274-20

FDA Recall
Open, Classified ·Inpeco S.A. Via San Gottardo 10 Lugano Switzerland·Product code CEM·March 10, 2023

Alinity h Interface Module (HSQ)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: FLX-274-20

FDA Enforcement
Class II ·Ongoing·Inpeco S.A.·May 10, 2023

Accelerator a3600 Automation System used with the following Modules: High Volume Storage(P/N FLX-270, FLX-271, FLX-276, FLX-282, FLX-283), HSQ Interface Module (P/N FLX-274), Aliquoter Module (P/N FLX-209), Rack Output Module ROM400 (P/N FLX-289), XN-9000 Interface Module (P/N FLX-290), Advia 2120 LAS Interface Module (P/N FLX-219), Vertical Transportation Module (P/N FLX -204), Rack Input Module (P/N FLX-214), AUWi System Interface Module (P/N FLX-286), Track To Rack Interface Module (P/N FLX-295) - Product Usage: is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The systems consolidate multiple Analytical instruments into a unified workstation.

FDA Enforcement
Class II ·Terminated·Inpeco S.A.·June 3, 2020

FlexLab Automation System used with the following Modules: High Volume Storage(P/N FLX-270, FLX-271, FLX-276, FLX-282, FLX-283), HSQ Interface Module (P/N FLX-274), Aliquoter Module (P/N FLX-209), Rack Output Module ROM400 (P/N FLX-289), XN-9000 Interface Module (P/N FLX-290), Advia 2120 LAS Interface Module (P/N FLX-219), Vertical Transportation Module (P/N FLX -204), Rack Input Module (P/N FLX-214), AUWi System Interface Module (P/N FLX-286), Track To Rack Interface Module (P/N FLX-295) - Product Usage: is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The systems consolidate multiple Analytical instruments into a unified workstation.

FDA Enforcement
Class II ·Terminated·Inpeco S.A.·June 3, 2020

Accelerator a3600 Automation System used with the following Modules: High Volume Storage(P/N FLX-270, FLX-271, FLX-276, FLX-282, FLX-283), HSQ Interface Module (P/N FLX-274), Aliquoter Module (P/N FLX-209), Rack Output Module ROM400 (P/N FLX-289), XN-9000 Interface Module (P/N FLX-290), Advia 2120 LAS Interface Module (P/N FLX-219), Vertical Transportation Module (P/N FLX -204), Rack Input Module (P/N FLX-214), AUWi System Interface Module (P/N FLX-286), Track To Rack Interface Module (P/N FLX-295) - Product Usage: is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The systems consolidate multiple Analytical instruments into a unified workstation.

FDA Recall
Terminated ·Inpeco S.A. Via San Gottardo 10 Lugano Switzerland·Product code JQP·April 7, 2020

FlexLab Automation System used with the following Modules: High Volume Storage(P/N FLX-270, FLX-271, FLX-276, FLX-282, FLX-283), HSQ Interface Module (P/N FLX-274), Aliquoter Module (P/N FLX-209), Rack Output Module ROM400 (P/N FLX-289), XN-9000 Interface Module (P/N FLX-290), Advia 2120 LAS Interface Module (P/N FLX-219), Vertical Transportation Module (P/N FLX -204), Rack Input Module (P/N FLX-214), AUWi System Interface Module (P/N FLX-286), Track To Rack Interface Module (P/N FLX-295) - Product Usage: is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The systems consolidate multiple Analytical instruments into a unified workstation.

FDA Recall
Terminated ·Inpeco S.A. Via San Gottardo 10 Lugano Switzerland·Product code CEM·April 7, 2020

Belt, Pelvic, Traction

FDA classification
FDA Class 1 ·Belt, Pelvic, Traction

HSD EUROPE SRL

Manufacturer
🇮🇹 Italy

TSQ Global SRL

Manufacturer
🇮🇹 Italy

RSQ Technologies Sp. z o.o.

Manufacturer
🇵🇱 Poland

BlueDop Medical Ltd

Manufacturer

HSG-S CORP

FDA registration
HSG-S CORP·10 products·🇺🇸 United States

HSC CO., LTD.

FDA registration
HSC CO., LTD.·2 products·🇰🇷 South Korea