44 results
·
7ms
·
Sources: EU EUDAMED, US FDA
Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.
FDA Enforcement
Class I
·Terminated·Animas Corporation·April 10, 2013
ADULT CHEST TUBE TRAY. Medical convenience kit, Avid Medical Part Number: LAKC001-04
FDA Enforcement
Class I
·Terminated·Avid Medical, Inc.·June 16, 2021
Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
FDA Enforcement
Class I
·Terminated·Abbott Molecular, Inc.·October 20, 2021
Neuro Omega System, incorporating HaGuide software. For neurological and neurosurgical use. To monitor, record and display bioelectric signals, and stimulate nerves and brain tissue.
FDA Enforcement
Class I
·Terminated·Alpha Omega Engineering·May 15, 2019
GemStar Docking Station, used with GemStar infusion pump, in combination with other GemStar accessories such as the GemStar Lock Box and patient bolus cord. The docking station is also used for hosting the GemStar pump for general infusions. List Numbers: 13075-XX-XX.
FDA Enforcement
Class I
·Terminated·Hospira Inc.·May 7, 2014
Nova Max Glucose Test Strips (50 Count Retail) Catalog Number: 43437 Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control
FDA Enforcement
Class I
·Terminated·Nova Biomedical Corporation·August 21, 2013
Nova Max Glucose Test Strips (50 Count DME) Catalog Number: 43523 Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control
FDA Enforcement
Class I
·Terminated·Nova Biomedical Corporation·August 21, 2013
Kit: Midline Insertion DA. MAI Kit Part Number: 77981B
FDA Enforcement
Class I
·Terminated·Medical Action Industries, Inc. 306·May 19, 2021
FISTULA (ON/OFF) ALL IN ONE BAG. Medical convenience kit, Avid Medical Part Number: VAMK024-03
FDA Enforcement
Class I
·Terminated·Avid Medical, Inc.·June 16, 2021
DIALYSIS ACCESS Medical convenience kit, Avid Medical Part Number: VMED004-03.
FDA Enforcement
Class I
·Terminated·Avid Medical, Inc.·June 16, 2021
DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming Set
FDA Enforcement
Class I
·Terminated·Deroyal Industries, Inc. Lafollette·October 6, 2021
Microscan Synergies Plus Negative Urine Combo 2 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria.
FDA Enforcement
Class I
·Terminated·Siemens Healthcare Diagnostics, Inc.·September 18, 2013
OXY-1 System, Model Number 001-0500-001. Used during cardiopulmonary bypass. OXY-1 System consists of Console, Pump Drive, E Drive, and Pole Mount. The disposable Pump Lung Unit PLU part number 001-0400-100 is sold separately and is not part of this recall.
FDA Enforcement
Class I
·Terminated·Abiomed, Inc.·February 9, 2022
Microscan Synergies Plus Negative Breakpoint Combo 7 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria.
FDA Enforcement
Class I
·Terminated·Siemens Healthcare Diagnostics, Inc.·September 18, 2013
Nova Max Plus Monitor System (Kit w/10 Count Vials) Catalog Number: 43435 Product usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control
FDA Enforcement
Class I
·Terminated·Nova Biomedical Corporation·August 21, 2013
Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
FDA Enforcement
Class I
·Terminated·Abbott Molecular, Inc.·October 20, 2021
AlboGraft Woven with Collagen, Straight 30x24 Catalog Number: ATC3024 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
FDA Enforcement
Class I
·Terminated·LeMaitre Vascular, Inc.·July 31, 2013
AlboGraft Knitted with Collagen, Bifurcate 14x08 Catalog Number: AMC1408 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
FDA Enforcement
Class I
·Terminated·LeMaitre Vascular, Inc.·July 31, 2013
AlboGraft Knitted with Collagen, Straight 60x08 Catalog Number: AMC6008 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
FDA Enforcement
Class I
·Terminated·LeMaitre Vascular, Inc.·July 31, 2013
AlboGraft Woven with Collagen, Straight 15x30 Catalog Number: ATC1530 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
FDA Enforcement
Class I
·Terminated·LeMaitre Vascular, Inc.·July 31, 2013