116 results
·
29ms
·
Sources: EU EUDAMED, US FDA
Filters
FDA Recall
×
intelliPATH Universal HRP Detection Kit, REF: IPK5011G80, containing DAB Buffer, Catalog Number: IPBF5009G20; ONCORE Pro DAB Chromogen, REF: OPRI6056KT180, containing DAB Buffer, Catalog Number: OPRI6055T60; IP DAB Chromogen Kit 80 ml, REF: IPK5010G80, containing DAB Buffer, Catalog Number: IPBF5009G20; DAB kit, REF: OPRI6056KT180, containing DAB Buffer, Catalog Number: OPRI6055T60 Folate Receptor alpha IHC Assay Kit, REF: IPI4006KG10, containing DAB Buffer, Catalog Number: IPBF5009G20
FDA Recall
Open, Classified
·Biocare Medical, LLC·Product code PPM·September 25, 2024
Brand Name: OBM00002 OBM DAB (Digital Acquisition Box) Product Name: OBM00002 OBM DAB (Digital Acquisition Box) Model/Catalog Number: OBM00002 OBM DAB (Digital Acquisition Box) Software Version: N/A Product Description: OBM00002 OBM DAB (Digital Acquisition Box) Component: No
FDA Recall
Open, Classified
·Natus Neurology DBA Excel Tech., Ltd. (XLTEK)·Product code OMA·May 7, 2025
DAC 044 115cm, Catalog: 90760
FDA Recall
Open, Classified
·Stryker Neurovascular·Product code DQY·April 23, 2024
PDSIIVIO30IN(75CM)USP6-0(M0.7)D/AC-1
FDA Recall
Open, Classified
·Ethicon Endo Surgery, LLC·Product code NEW·March 7, 2025
PDSPLUSVIO30IN(75CM)USP6-0(M0.7)D/AC-1MP
FDA Recall
Open, Classified
·Ethicon Endo Surgery, LLC·Product code NEW·March 7, 2025
iVIEW DAB Detecion Kit. Catalog Number 760-091
FDA Recall
Terminated
·Ventana Medical Systems Inc·Product code KTO·May 7, 2003
iView DAB IHC Detection Kit, Ventana part Number 760-091, Roche GMMI 05266157001 in vitro diagnostic
FDA Recall
Terminated
·Ventana Medical Systems Inc·Product code NJT·December 19, 2017
ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code GKZ·March 5, 2021
ultraView Universal DAB Detection Kit, Ventana part Number 760-500, Roche GMMI 05269806001 in vitro diagnostic
FDA Recall
Terminated
·Ventana Medical Systems Inc·Product code NJT·December 19, 2017
ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - US, automated hematology analyzer Software Versions 6.10 and 6.11
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code GKZ·March 5, 2021
OptiView DAB IHC Detection Kit, Ventana Part Number 760-700, Roche GMMI 06396500001 in vitro diagnostic
FDA Recall
Terminated
·Ventana Medical Systems Inc·Product code NJT·December 19, 2017
iView DAB Detection Kit, Catalog Number 05266157001, model 760-091 Immunohistochemistry (IHC) for in vitro diagnostic use.
FDA Recall
Terminated
·Ventana Medical Systems Inc·Product code NJT·August 2, 2018
iView DAB Detection Kit w/o Secondary Antibody, Catalog Number 05266173001, Model 760-093. For laboratory use.
FDA Recall
Terminated
·Ventana Medical Systems Inc·Product code NJT·August 2, 2018
OptiView DAB IHC Detection Kit, Catalog Number 06396500001, model 760-700 Immunohistochemistry (IHC) for in vitro diagnostic use.
FDA Recall
Terminated
·Ventana Medical Systems Inc·Product code NJT·August 2, 2018
ultraView Universal DAB Detection Kit, Catalog Number 05269806001, model 760-500 Immunohistochemistry (IHC) for in vitro diagnostic use.
FDA Recall
Terminated
·Ventana Medical Systems Inc·Product code NJT·August 2, 2018
NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Ventana Part Number 760-041, Roche GMMI 05266084001 in vitro diagnostic
FDA Recall
Terminated
·Ventana Medical Systems Inc·Product code NJT·December 19, 2017
NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Catalog Number 05266084001 Model 760-041 Immunohistochemistry (IHC) for in vitro diagnostic use.
FDA Recall
Terminated
·Ventana Medical Systems Inc·Product code NJT·August 2, 2018
Intralase FS Laser System. Laser Keratome
FDA Recall
Terminated
·Product code GEX·July 15, 2003
Welch Allyn AED 10 automated external defibrillator and MRL Jumpstart (collectively "AED 10")
FDA Recall
Terminated
·Welch Allyn Protocol, Inc·Product code MKJ·February 26, 2009
iView DAB Detection Kit, Part number: 760-091 (05266157001) This detection kit is intended for in vitro diagnostic use. Ventana Medical Systems' (Ventana) iVIEW DAB Detection Kit is an indirect biotin streptavidin system for detecting mouse IgG, mouse IgM and rabbit primary antibodies. The kit is intended for laboratory use to identify targets by immunohistochemistry (IHC) in sections of formalin fixed, paraffin embedded and frozen tissue on Ventana Medical Systems (Ventana) automated slide stainers by light microscopy. The clinical interpretation of any staining, or the absence of staining, must be complemented by morphological studies and evaluation of proper controls. Evaluation must be made by a qualified pathologist within the context of the patient's clinical history and other diagnostic tests.
FDA Recall
Terminated
·Ventana Medical Systems Inc·Product code MYA·May 16, 2011