48 results
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20ms
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Sources: EU EUDAMED, US FDA
Octopus Evolution AS Tissue Stabilizer, Model TS2500
FDA Recall
Open, Classified
·Medtronic Perfusion Systems·Product code MWS·May 12, 2026
Octopus 4 Tissue Stabilizer, Model 29400
FDA Recall
Open, Classified
·Medtronic Perfusion Systems·Product code MWS·May 12, 2026
Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1
FDA Recall
Open, Classified
·Medtronic Perfusion Systems·Product code MWS·January 13, 2026
Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000Z
FDA Recall
Open, Classified
·Maquet Cardiovascular, LLC·Product code MWS·October 16, 2024
Acrobat-i Vacuum Stabilizer System. Model Number C-OM-10000Z
FDA Recall
Open, Classified
·Maquet Cardiovascular, LLC·Product code MWS·October 16, 2024
Acrobat-i Vacuum Positioner System, Model Number XP-5000Z
FDA Recall
Open, Classified
·Maquet Cardiovascular, LLC·Product code MWS·October 31, 2023
Octopus Evolution Tissue Stabilizer, Model TS2000
FDA Recall
Open, Classified
·Medtronic Perfusion Systems·Product code MWS·May 12, 2026
Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac surgical procedures through a sternotomy incision approach. Product Code: OM-10000Z
FDA Recall
Open, Classified
·Maquet Cardiovascular, LLC·Product code MWS·September 13, 2023
Acrobat-i Positioner. Model Number C-XP-5000Z
FDA Recall
Open, Classified
·Maquet Cardiovascular, LLC·Product code MWS·October 16, 2024
Disposable Surgical Level 3 Gown, Size/Product Code: Large/GWS-03-L-B, XLarge/GWS-03-XL-B, XXLarge/GWS-03-XXL-B
FDA Recall
Open, Classified
·Texas Medical Technology Inc.·Product code FYA·September 1, 2022
Body Weight Support (BWS) Light; Model No. RB011; a component of C-Mill, Grail, M-Gait - Product Usage: is designed to facilitate functional gait training of subjects with gait and/or balance impairment by providing dynamic partial vertical unloading during walking on a treadmill. The device will be used as an assistive device for gait deficiency rehabilitation and research purposes.
FDA Recall
Open, Classified
·MOTEK MEDICAL B.V. Hogehilweg 18 18 Unit C Amsterdam Netherlands·Product code BXB·July 29, 2019
Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) REF IAB-05840-LWS; c) REF IAB-05850-LWS
FDA Recall
Open, Classified
·ARROW INTERNATIONAL Inc.·Product code DSP·April 29, 2024
NxStage Cartridge Express with Speedswap, Catalog No. CAR-535. An accessory device for facilitating the removal and replacement of a flow-compromised filter during treatment of acute and chronic renal failure or fluid overload.
FDA Recall
Open, Classified
·NxStage MDS Corporation·Product code KDI·January 29, 2024
ROSA One 3.1 Brain application The device is intended for the spatial positioning and orientation of instruments holders or tool guides to be used by trained surgeons to guide standard surgical instruments during brain and spine surgeries.
FDA Recall
Open, Classified
·MEDTECH SAS 900 Rue Du Mas De Verchant Montpellier France·Product code HAW·September 22, 2021
AltiVate Anatomic Shoulder System for the following Part Numbers: 1. Part # 520-08-00, Rev. C., 2. Part # 520-10-000, 3. Part # 520-12-000, 4. Part # 520-14-000, 5. Part # 520-16-000
FDA Recall
Open, Classified
·Product code KWS·June 28, 2021
Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, LEFT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-04-22, b) 41, 44, 47, 50 head, Medium, Item Number 314-04-23, c) 44, 47, 50, 53 head, Large, Item Number 314-04-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-04-25; Shoulder Arthroplasty
FDA Recall
Open, Classified
·Exactech, Inc.·Product code KWS·March 6, 2024
Exactech Equinoxe Shoulder System, Catalog Numbers: a) 314-23-02, b) 314-23-03, c) 314-23-13, d) 314-23-14, e) 314-23-15, f) 314-24-22, g) 314-24-23, h) 314-24-24, i) 314-24-32, j) 314-24-33, k) 314-24-34, l) 314-24-35
FDA Recall
Open, Classified
·Exactech, Inc.·Product code KWS·November 21, 2023
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
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Recall
Open, Classified
·Exactech, Inc.·Product code KWS·March 6, 2024
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Recall
Open, Classified
·Exactech, Inc.·Product code KWS·March 6, 2024