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