45 results
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21ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4599P-1
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·November 1, 2023
ABG II Modular Hip Stem Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430 Stryker Ireland Carrigtwohill Industrial Estate, Carrigtwohill County Cork, Ireland. The ABG II Modular range of implants is constituted of 8 right stems and 8 left stems. The necks are made of GADS Vitallium, a proprietary Co Cr alloy that Stryker has developed. GADS stands for Gas Atomized Dispersion Strengthened. IT is a Co Cr alloy that is a corrosion resistant and demonstrates qualities of improved fatigue strength (with respect to regular Co Cr alloy). Neck Range - The ABG II modular neck range is composed of 10 reversible neck implants. There are different options in terms of length, version and neck angle. The AG II Modular necks come in two different lengths: 28 mm (short) and 36 mm (long). The necks are offered in two version angles ; 0 and 7. The 0 and 7 necks are available in 125, 130 and 135 neck angles.
FDA Enforcement
Class II
·Ongoing·Stryker Howmedica Osteonics Corp.·August 1, 2012
Blood Type Test
FDA Enforcement
Class II
·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025
a. Comply INDICATOR, COMPLY VAPOR GAS (250/BG 4BG/CS) 3M Model Number: 1248. b. 3M Attest INDICATOR, CHEMICAL VAPORIZEDHYDROGEN PEROXIDE (250/BG) Model Number: 1348.
FDA Enforcement
Class III
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·October 5, 2022
20" Lead Wires, Replacement Part Number: 1067724-2
FDA Enforcement
Class II
·Ongoing·EBI, LLC·May 1, 2024
48" Lead Wires, Replacement Part Number: 1067724-4
FDA Enforcement
Class II
·Ongoing·EBI, LLC·May 1, 2024
Biomet OrthoPak Non-invasive Bone Growth Stimulator System-Indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones. Part Number: 1067718
FDA Enforcement
Class II
·Ongoing·EBI, LLC·May 1, 2024
Biomet SpinalPak Non-invasive Spine Fusion Stimulator System- Indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones, Part Number: 1067716
FDA Enforcement
Class II
·Ongoing·EBI, LLC·May 1, 2024
Edge Biologicals STERILE WATER, 3ML, 100/PK CAT T-0780 Sterile Water, 3mL, 10/PK - Sterile water is used in making dilutions of samples/transport media in preparation for microbial testing of the sample. It is also used for diluting sterile reagents and microorganism preparations
FDA Enforcement
Class II
·Ongoing·Edge Biologicals Inc·April 30, 2025
NanoSight LM10 fitted with LM14 module. A laboratory instrument for determination of particle characteristics (e.g. size).
FDA Enforcement
Class II
·Ongoing·MALVERN PANALYTICAL LTD·October 5, 2022
NanoSight LM10 fitted with LM12 module. A laboratory instrument for determination of particle characteristics (e.g. size).
FDA Enforcement
Class II
·Ongoing·MALVERN PANALYTICAL LTD·October 5, 2022
Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23055 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: No
FDA Enforcement
Class II
·Ongoing·CooperSurgical, Inc.·December 25, 2024
Brand Name: K-Systems Product Name: G85 Mini Incubator Model/Catalog Number: K22074 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: No
FDA Enforcement
Class II
·Ongoing·CooperSurgical, Inc.·December 25, 2024
Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23054 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: No
FDA Enforcement
Class II
·Ongoing·CooperSurgical, Inc.·December 25, 2024
Brand Name: K-Systems Product Name: G73 Dry Bath Incubator Model/Catalog Number: K22065 Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: N/A
FDA Enforcement
Class II
·Ongoing·CooperSurgical, Inc.·December 25, 2024
Brand Name: K-Systems Product Name: R65 Trolley Model/Catalog Number: K24012 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: N/A
FDA Enforcement
Class II
·Ongoing·CooperSurgical, Inc.·December 25, 2024
Brand Name: K-Systems Product Name: Multiple/unknown Model/Catalog Number: Multiple/unknown Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: N/A
FDA Enforcement
Class II
·Ongoing·CooperSurgical, Inc.·December 25, 2024
ErgoStar CM 55, Model/Catalog Number: MP01855, Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mechanically ventilated patient.
FDA Enforcement
Class I
·Ongoing·Draeger, Inc.·December 17, 2025
ErgoStar CM 45, Model/Catalog Number: MP01845, Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mechanically ventilated patient.
FDA Enforcement
Class I
·Ongoing·Draeger, Inc.·December 17, 2025
ErgoStar CM 60, Model/Catalog Number: MP01860, Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mechanically ventilated patient.
FDA Enforcement
Class I
·Ongoing·Draeger, Inc.·December 17, 2025