13 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
×
Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000Z
FDA Enforcement
Class II
·Ongoing·Maquet Cardiovascular, LLC·November 27, 2024
Acrobat-i Vacuum Stabilizer System. Model Number C-OM-10000Z
FDA Enforcement
Class II
·Ongoing·Maquet Cardiovascular, LLC·November 27, 2024
TOMTEC-ARENA TTA2;software version no. 2.20 and lower; Picture archiving and communications system. Software Versions and applicable UDI: TTA 1.2 release prior to UDI requirement TTA2.00.01 release prior to UDI requirement TTA2.11.01 release prior to UDI requirement TTA2.11.02 release prior to UDI requirement TTA2.20.01 UDI: (01)04260361440143(11)160429(10)20.01 TTA2.20.10 UDI:(01)04260361440143(11)160809(10)20.10 TTA2.20.13 UDI:(01)04260361440143(11)160922(10)20.13 TTA2.20.14 UDI:(01)04260361440143(11)161028(10)20.14 TTA2.20.15 UDI: (01)04260361440143[11]161207[10]20.15 TTA2.20.16 UDI:(01)04260361440143(11)170127(10)20.16 TTA2.20.18 UDI:(01)04260361440143(11)170622(10)20.18
FDA Enforcement
Class II
·Ongoing·Tomtec Imaging Systems Gmbh·July 15, 2020
ACROBAT-i Vacuum Stabilizer System, Part Number C-OM-10000. Component of a chest stabilization system for cardiac and chest surgery.
FDA Enforcement
Class II
·Ongoing·Maquet Cardiovascular, LLC·August 9, 2023
ACROBAT SUV Vacuum Off-Pump System, Part Number C-OM-9000S. Component of a chest stabilization system for cardiac and chest surgery.
FDA Enforcement
Class II
·Ongoing·Maquet Cardiovascular, LLC·August 9, 2023
ACROBAT V Vacuum Off-Pump System, Part Number C-OM-9100S. Component of a chest stabilization system for cardiac and chest surgery.
FDA Enforcement
Class II
·Ongoing·Maquet Cardiovascular, LLC·August 9, 2023
(1) Lumenis Pulse 120H 30 amp, REF GA 2009996, Laser System; (2) Lumenis Pulse 120H, Moses 2.0 (DOM), REF GA0006802, Laser System; and (3) Lumenis Pulse 120H, REF GA-0008700, Laser System.
FDA Enforcement
Class II
·Ongoing·LUMENIS, LTD.·March 12, 2025
Brand Name: MEDLINE Product Name: SYR 30ML L/L Model/Catalog Number: 83078 Product Description: NON-Sterile syringes without needles for single use Component: No
FDA Enforcement
Not Yet Classified
·Ongoing·Jiangsu Shenli Medical Production Co., Ltd.·May 29, 2024
BD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 The BD AlarisTM System with Guardrails" Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent administration of fluids to adult, pediatric, and neonatal patients through clinically accepted routes of administration: intravenous (IV), intra-arterial (IA), subcutaneous, epidural, or irrigation of fluid spaces. The BD AlarisTM System includes the PC Unit (PCU) and one or more of the following: Pump Module, Syringe Module, end-tidal CO2 (EtCO2) Module, Auto-ID Module, patient-controlled analgesia (PCA) Module, and associated software applications.
FDA Enforcement
Class II
·Ongoing·CareFusion 303, Inc.·February 4, 2026
Model: Incisive CT for Brazil SKD; Product Code (REF): 728146; Software Versions: 5.1.0.X & 5.1.1.X;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS·November 5, 2025
NOA Medical Industries Behavioral Health Hospital bed side rails, Product number 1055050GRY-BOX
FDA Enforcement
Class II
·Ongoing·NOA Medical Industries Inc·January 22, 2025
Model: Incisive CT; Product Code (REF): (1) 728143, (2) 728144; Software Versions: 5.1.0.X & 5.1.1.X;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS·November 5, 2025
Model: CT 5300; Product Code (REF): 728285; Software Versions: 5.1.0.X & 5.1.1.X;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS·November 5, 2025