560 results
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12ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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Corin BIOLOX DELTA MOD HEAD,032mm, EX LONG +7mm, REF 104.3215
FDA Enforcement
Class II
·Ongoing·Corin Ltd·December 28, 2022
Unity CR Femur Right, Size 6, Model Number 112.001.32 Primary and revision total knee arthroplasty
FDA Enforcement
Class II
·Ongoing·Corin Ltd·November 8, 2023
VS3 Iridium Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS-IR) Product Number: 174-0012
FDA Enforcement
Class II
·Ongoing·Visionsense, Ltd.·November 30, 2022
AirFit N10 Nasal Masks and User Guide
FDA Enforcement
Class I
·Ongoing·ResMed Ltd.·December 27, 2023
RET Proximal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome.
FDA Enforcement
Class II
·Ongoing·Cytocell Ltd.·July 26, 2023
AirFit N20 Nasal Mask and User Guide
FDA Enforcement
Class I
·Ongoing·ResMed Ltd.·December 27, 2023
STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. Model: G4 621103
FDA Enforcement
Class II
·Ongoing·Scican Ltd.·August 9, 2023
STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. Model: G4 622303
FDA Enforcement
Class II
·Ongoing·Scican Ltd.·August 9, 2023
RET Distal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome.
FDA Enforcement
Class II
·Ongoing·Cytocell Ltd.·July 26, 2023
AirTouch N20 Nasal Mask and User Guide
FDA Enforcement
Class I
·Ongoing·ResMed Ltd.·December 27, 2023
AirFit F20 Full Face Mask and User Guide
FDA Enforcement
Class I
·Ongoing·ResMed Ltd.·December 27, 2023
Astral 100 and Astral 150 ventilators
FDA Enforcement
Class I
·Ongoing·ResMed Ltd.·November 1, 2023
The EnPlace is a single use trans-vaginal pelvic floor repair system which enables delivery of a tissue anchor to the ligaments of the vaginal cavity. The anchors are pre-loaded inside the device shaft and are ready for use. A thimble is also supplied, as an accessory for the device, to be used as a guide channel for better handling of the EnPlace. Intended Use / Indications for Use: The EnPlace system is intended for attaching sutures to ligaments of the pelvic floor.
FDA Enforcement
Class II
·Ongoing·FEMSelect Ltd·February 9, 2022
AirFit F30 Full Face Mask and User Guide
FDA Enforcement
Class I
·Ongoing·ResMed Ltd.·December 27, 2023
VS3 Iridium Visionsense Infrared (IR) Fluorescence Light Integrator (Beam Combiner) Product Number: 161-0001
FDA Enforcement
Class II
·Ongoing·Visionsense, Ltd.·November 30, 2022
VS3 Iridium - Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS) - 785nm Product Number: 175-0012
FDA Enforcement
Class II
·Ongoing·Visionsense, Ltd.·November 30, 2022
AirTouch F20 Full Face Mask and User Guide
FDA Enforcement
Class I
·Ongoing·ResMed Ltd.·December 27, 2023
Corin BIOLOX DELTA MOD HEAD, 036mm EX LONG +8mm, REF 104.3615
FDA Enforcement
Class II
·Ongoing·Corin Ltd·December 28, 2022
Unity Total Knee System, Model Number 112.001.34. Primary and revision total knee arthroplasty
FDA Enforcement
Class II
·Ongoing·Corin Ltd·November 8, 2023
AirFit F30i Full Face Mask and User Guide
FDA Enforcement
Class I
·Ongoing·ResMed Ltd.·December 27, 2023