1,029 results · 56ms · Sources: EU EUDAMED, US FDA

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NEW CHOICE

FDA Adverse Event
IND DIAGNOSTIC INC.·Product code LCX·February 2, 2005

DIMENSION CLINICAL CHEMISTRY SYSTEM

FDA Adverse Event
Malfunction ·SIEMNS HEALTHCARE DIAGNOSITICS INC·Product code MMI·December 8, 2008

SYNCHRON LX® I 725 CLINICAL SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER INC.·Product code MMI·April 16, 2009

ACCESS 2 IMMUNOASSAY SYSTEM

FDA Adverse Event
Other ·BECKMAN COULTER, INC.·Product code JJE·November 8, 2007

VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK

FDA Adverse Event
Malfunction ·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code JLW·November 28, 2023

UNICEL ® DXC600I SYNCHRON ® ACCESS ® CLINICAL SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER INC.·Product code JJE·July 18, 2011

ACCESS 2 IMMUNOASSAY SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER, INC.·Product code JJE·July 1, 2011

ACCESS® TOTAL BETA-HCG REAGENT KIT

FDA Adverse Event
Malfunction ·BECKMAN COULTER INC.·Product code JHI·February 16, 2012

GEENEN PANCREATIC STENT

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FGE·September 28, 2020

AUTOSTAINER LINK 48

FDA Adverse Event
Malfunction ·AGILENT TECHNOLOGIES SINGAPORE (INTL.) PTE LTD.·Product code KPA·June 1, 2023

MTS A/B/D MONO & REV GRP 5X20

FDA Adverse Event
Malfunction ·MICROTYPING SYSTEMS·Product code QHR·November 22, 2022

COPAN FLOQSwabs, STERILE.EO, for drawing clinical samples. CE0123, for the following reference numbers REF:501CS01, Minitip, sterile Single Wrapped, Molded bp 80mm; REF: 20226, P/N 501CS01Q100, Minitip, Sterile, Single Wrapped, bp 60MM, BUNDLES OF 20 pcs; REF: 501CS01.Q20, P/N 1127700, Minitip Applicator Sterile Ind. wrapped., bp 60mm, bundles of 20; REF: 502CS01, Regular, Sterile single Wrapped, Molded bp 80mm; REF: 503CS01, Flexible, Sterile Single Wrapped, Molded bp 100mm; REF: 220252, P/N 503CS01.BD, Flexible, Sterile Single Wrapped Molded bp 100 mm; REF: 503CS01/503CS01.BX, Flexible, Sterile Single Wrapped, Molded bp 100mm REF: 50U004DS, hDNA Free, Regular sterile in dry tube Molded Break Point 20 mm; REF: 50U009DS02, hDNA Free, Regular, Sterile, 2pcs Packed; REF: 518CS01, Minitip, Ster. Single Wrapped, Molded bp 100mm; REF: 220251, P/N: 518CS01.BD, Minitip, sterile Single Wrapped Molded bp 100mm; REF: 519C/519C.BX, Regular Sterile, Molded break point 100 mm; REF: 220250 P/N: 519CS01.BD, Regular, Sterile Single wrapped Molded bp 100mm; REF: 525CS01, Ultra-Thin Minitip, sterile single wrapped, molded bp 80 mm; REF: 528C, Large Tip Swab, Handle with Stopper, in dry tube REF: 534CS01, Flexible Nylon, Sterile Single Wrapped; REF: 551C, Minitip Sterile in dry tube, Molded Break Point 80 mm; REF: 552C/552C.BX, Regular sterile in dry tube Molded Break Point 80 mm; REF: 553C, Flexible sterile in dry tube, molded bp 100 mm; REF: 553C.LC, Flexible Sterile in dry tube, molded bp 100 mm; REF: 5U002S, Regular, sterile, in tube, 80 mm breakpoint, with low stopper; 5U048N01.BIO, REF: 5U055S02.HG, Regular FLOQSwabs with 20mm breakpoint 100 peelpouches, 2 swabs per peelpouch; REF: 5U056S.IUO, FLOQSwats ADULT IN DRY TUBE, Investigational Use Only; REF: 5UO57S.IUO, FLOQSwabs CHILD IN DRY TUBE, Investigational Use Only

FDA Recall
Terminated ·Copan Italia Via Francesco Perotti 10 Brescia Italy·Product code KXG·July 9, 2021

MDSS GmbH

Authorized representative
🇩🇪 Germany·388 Manufacturers·16562 Devices

Medical Technology Promedt Consulting GmbH

Authorized representative
🇩🇪 Germany·194 Manufacturers·10009 Devices

Caliber Imaging & Diagnostics, Inc.

Manufacturer
🇺🇸 United States

Geneseeq Medical Device and Diagnostic Inc.

Manufacturer
🇨🇳 China·1 Basic UDI-DI·1 Device

Emergo Europe B.V.

Authorized representative
🇳🇱 Netherlands·900 Manufacturers·22100 Devices

Caliber Imaging & Diagnostics, Inc.

FDA registration
Caliber Imaging & Diagnostics, Inc.·4 products·🇺🇸 United States

GENESEEQ MEDICAL DEVICE AND DIAGNOSTIC INC.

FDA registration
GENESEEQ MEDICAL DEVICE AND DIAGNOSTIC INC.·1 product·🇨🇳 China

SARS-CoV-2 Nucleic Acid Detection Kit(qRT-PCR)

Device
EU IVDD · Eu Ivd General ·Geneseeq Medical Device and Diagnostic Inc.·On the market