242 results
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15ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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Sternal Valve Retractors With Atrial and Aortic Rakes; Models SRCL-1, SRCL-AR, SRLP-1, SRLP-AR, ATR-1, ATR-AR, CSR-1 and CSR-AR. For use in cardiac surgery.
FDA Recall
Open, Classified
·Genesee BioMedical, Inc.·Product code DWS·February 26, 2018
SENTIERO Screening2, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S2
FDA Recall
Open, Classified
·PATH Landsberger Str. 65 Germering Germany·Product code EWO·September 26, 2023
SENTIERO SCREENING, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S
FDA Recall
Open, Classified
·PATH Landsberger Str. 65 Germering Germany·Product code EWO·September 26, 2023
SENTIERO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098
FDA Recall
Open, Classified
·PATH Landsberger Str. 65 Germering Germany·Product code EWO·September 26, 2023
AuDX PRO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-AUP
FDA Recall
Open, Classified
·PATH Landsberger Str. 65 Germering Germany·Product code EWO·September 26, 2023
MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)
FDA Recall
Open, Classified
·PATH Landsberger Str. 65 Germering Germany·Product code GWJ·November 6, 2025
Corin Operating Tables Model Numbers: (1) 770001A0, (2) 770001A2, (3) 770001B0, (4) 770001B2, (5) 770001F0, (6) 770001F2; All Software Versions.
FDA Recall
Open, Classified
·MAQUET GMBH Kehler Str. 31 Rastatt Germany·Product code FQO·July 14, 2025
QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients suspected of respiratory infection for the presence of viral or bacterial nucleic acids REF 691223
FDA Recall
Open, Classified
·Qiagen GmbH Qiagen Str. 1 Hilden Germany·Product code QLT·May 19, 2023
therascreen KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used on the Rotor-Gene Q MDx instrument for the detection of seven somatic mutations in the human KRAS oncogene REF 870021 (US IVD)
FDA Recall
Open, Classified
·Qiagen GmbH Qiagen Str. 1 Hilden Germany·Product code OWD·August 22, 2023
QIAstat-Dx Respiratory SARS-CoV-2 Panel -IVD intended for the detection and differentiation of nucleic acid from SARS-CoV-2 and the following organism types and subtypes: Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, SARS-CoV-2, Human Metapneumovirus A+B, Influenza A, Influenza A H1, Influenza A H3, Influenza A H1N1/pdm09, Influenza B, Parainfluenza virus 1, Parainfluenza virus 2, Parainfluenza virus 3, Parainfluenza virus 4, Rhinovirus/Enterovirus, Respiratory Syncytial Virus A+B, Bordetella pertussis, Chlamydophila pneumoniae, and Mycoplasma pneumoniae REF 691223
FDA Recall
Open, Classified
·Qiagen GmbH Qiagen Str. 1 Hilden Germany·Product code QJR·May 9, 2023
QIAstat-Dx Respiratory SARS-CoV-2 Panel (V1 and V2, CE IVD, not US IVD, not sold in the US.) Qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients suspected of respiratory infection REF: 691214
FDA Recall
Open, Classified
·Qiagen GmbH Qiagen Str. 1 Hilden Germany·Product code QLT·May 19, 2023
Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181030
FDA Recall
Open, Classified
·TELEFLEX LLC·Product code BTR·May 25, 2023
Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170085
FDA Recall
Open, Classified
·TELEFLEX LLC·Product code BTR·May 25, 2023
Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181055
FDA Recall
Open, Classified
·TELEFLEX LLC·Product code BTR·May 25, 2023
Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080080
FDA Recall
Open, Classified
·TELEFLEX LLC·Product code BTR·May 25, 2023
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781035
FDA Recall
Open, Classified
·TELEFLEX LLC·Product code BTR·May 25, 2023
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780035
FDA Recall
Open, Classified
·TELEFLEX LLC·Product code BTR·May 25, 2023
Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170050
FDA Recall
Open, Classified
·TELEFLEX LLC·Product code BTR·May 25, 2023
Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380060
FDA Recall
Open, Classified
·TELEFLEX LLC·Product code BTR·May 25, 2023
Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180060
FDA Recall
Open, Classified
·TELEFLEX LLC·Product code BTR·May 25, 2023