57 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-SYS-6000-2D, SDM-SYS-6000-3D, SDM-00001-2D, SDM-00001-3D, SDM-00001-M2D, SDM-00001-M3D, SDM-05000-2A2, SDM-05000-2A3, SDM-05000-2AC, SDM-05000-2D2, SDM-05000-2D3, SDM-05000-2DC, SDM-05000-3D2, SDM-05000-3D3, SDM-05000-3DC, SDM-SYS-9000-2D, SDM-SYS-9000-3D.
FDA Recall
Open, Classified
·Hologic, Inc·Product code MUE·April 8, 2026
Hologic 3Dimensions/Selenia Dimensions Models: RM-SDM-00001-3D SDM-00001-2D SDM-00001-3D SDM-05000-3D3 SDM-05000-2DC SDM-00001-M3D SDM-05000-3DC SDM-SYS-6000-3D SDM-05000-2D3 SDA-SYS-3000-2D SDM-00001 SDM-SYS-9000-2D SDM-00001-M2D 3DM-SYS-STD 3DM-SYS-STD-NS SDM-05000-2AC SDM-05000-2A2 SDA-SYS-3000-3D SDA-SYS-3000-3D-UPS SDM-SYS-6000-3D-HTC SDM-05000-2D2 SDM-05000-3D2 SDM-SYS-6000-2D SDM-SYS-9000-3D
FDA Recall
Open, Classified
·Hologic, Inc.·Product code OTE·January 16, 2023
ETHIBOND EXCEL GRN 36IN(90CM) USP2-0(M3) D/A MH
FDA Recall
Open, Classified
·Ethicon Endo Surgery, LLC·Product code NEW·March 7, 2025
STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: STRATAFIX SPIRAL MONOCRYL PLUS BI UD 12+12IN(30+30CM) USP3-0(M2) D/A PS PRM- Indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate. Product Code: SXMP2B412
FDA Recall
Open, Classified
·Ethicon, Inc.·Product code GAM·March 8, 2024
Sit to Stand STS500 Patient Lift
FDA Recall
Open, Classified
·Med-Mizer, Inc.·Product code FSA·February 3, 2023
Grace Medical REF S-4500 *** spineX BONE DUST COLLECTOR *** 2 stainless steel filters - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.
FDA Recall
Open, Classified
·Oto Med Inc·Product code MXP·December 7, 2020
Grace Medical REF S-2500 *** SHEEHY BONE DUST COLLECTOR *** Stainless steel filter - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.
FDA Recall
Open, Classified
·Oto Med Inc·Product code MXP·December 7, 2020
Med-Riser MR600 Patient Lift
FDA Recall
Open, Classified
·Med-Mizer, Inc.·Product code FSA·February 3, 2023
Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit, Catalog number 504600-28
FDA Recall
Open, Classified
·Inter-Med Llc·Product code MVL·May 27, 2026
Grace Medical REF S-3500 *** COX BONE DUST COLLECTOR *** 2 stainless steel filters - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.
FDA Recall
Open, Classified
·Oto Med Inc·Product code MXP·December 7, 2020
Mojo Full Face with Headgear, All Sizes
FDA Recall
Open, Classified
·SleepNet Corporation·Product code BZD·March 1, 2024
SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, REMstar SE Auto Noncontinuous Ventilators The Philips Respironics E30 ventilator is intended to provide invasive and non-invasive ventilatory support for individuals with Respiratory Insufficiency. It is specifically for the care of adult and pediatric patients >7 years of age and >18kgs.
FDA Recall
Open, Classified
·Philips Respironics, Inc.·Product code BZD·June 14, 2021
Magic3 Go Intermittent Urinary Catheters, Female Catalog Numbers: a) REF 51808, b) REF 51810, c) REF 51812, d) REF 51814, e) REF 51816, f) REF 51818
FDA Recall
Open, Classified
·C.R. Bard Inc·Product code EZD·April 20, 2023
DreamStation Auto BiPAP. Non-Continuous Ventilator.
FDA Recall
Open, Classified
·Philips Respironics, Inc.·Product code BZD·June 30, 2025
HydroSil Go Intermittent Urinary Catheters, Catalog Numbers: a) REF 71808, b) REF 71810, c) REF 71812, d) REF 71814, e) REF 71816, f) REF 71818
FDA Recall
Open, Classified
·C.R. Bard Inc·Product code EZD·April 20, 2023
Magic3 Go Intermittent Urinary Catheters, pediatric Catalog Numbers: a) REF 52810G
FDA Recall
Open, Classified
·C.R. Bard Inc·Product code EZD·April 20, 2023
Phantom 2 Nasal Vented Mask
FDA Recall
Open, Classified
·SleepNet Corporation·Product code BZD·March 1, 2024
Philips Respironics DreamWear Full Face Mask
FDA Recall
Open, Classified
·Philips Respironics, Inc.·Product code BZD·September 6, 2022
Therapy Mask 3100 NC/SP
FDA Recall
Open, Classified
·Philips Respironics, Inc.·Product code BZD·September 6, 2022
AirTouch F20 Full Face Mask and User Guide
FDA Recall
Open, Classified
·Product code BZD·November 20, 2023