10,000 results
·
14ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
×
LikoStretch Mod 600 IC Model Number: 3156065 LikoStretch Mod 600 IC, Wide Model Number: 3156065B (obsolete since 12JUN2020) - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient.
FDA Enforcement
Class II
·Ongoing·Hill-Rom, Inc.·October 6, 2021
Infection Control (IC) Lifting Strap used with the following Cirrus and Pinnacle Ceiling Lifts: Cirrus 450, Cirrus 600, Cirrus 700, Cirrus 750, and Pinnacle 1000
FDA Enforcement
Class II
·Ongoing·Tollos·November 23, 2022
Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS-15322-I
FDA Enforcement
Class I
·Ongoing·ARROW INTERNATIONAL, LLC·May 20, 2026
Draeger Infinity CentralStation (ICS), centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment, Software versions VG2.1.3 and lower
FDA Enforcement
Class II
·Ongoing·Draeger Medical Systems, Inc.·May 3, 2023
Bard Medical SureStep Foley Tray System, 16 Fr., Catalog #A319416AM; and Bard Medical Bardex IC Complete Care Infection Control Temperature-Sensing Foley Catheter Tray with Bard Hydrogel and Bacti-Guard Silver Alloy Coating, 350 ml Urine Meter, 16 Fr, Catalog #319416AM. Intended for use in the drainage and/or collection and/or measurement of urine.
FDA Enforcement
Class II
·Ongoing·C.R. Bard Inc·June 26, 2024
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 13 cm;
FDA Enforcement
Class II
·Ongoing·Mozarc Medical US LLC·November 12, 2025
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 16 cm;
FDA Enforcement
Class II
·Ongoing·Mozarc Medical US LLC·November 12, 2025
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm;
FDA Enforcement
Class II
·Ongoing·Mozarc Medical US LLC·November 12, 2025
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 24 cm;
FDA Enforcement
Class II
·Ongoing·Mozarc Medical US LLC·November 12, 2025
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Safety Components: 12 Fr/Ch (4.0 mm) x 24 cm;
FDA Enforcement
Class II
·Ongoing·Mozarc Medical US LLC·November 12, 2025
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm;
FDA Enforcement
Class II
·Ongoing·Mozarc Medical US LLC·November 12, 2025
EkoSonic Kit 135cm, 12cm TZ The EkoSonic Endovascular Device is packaged as a kit that includes both the USC and IC components. They are placed into the respective trays and sealed in a Tyvek pouch. The sealed pouches are placed inside the kit carton (box) and the product labels.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·August 10, 2022
EkoSonic Kit 106cm, 12cm TZ The EkoSonic Endovascular Device is packaged as a kit that includes both the USC and IC components. They are placed into the respective trays and sealed in a Tyvek pouch. The sealed pouches are placed inside the kit carton (box) and the product labels.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·August 10, 2022
Draeger Globe-Trotter and Globe-Trotter IC, Model numbers MS20508 and MS20509. neonatal transport system
FDA Enforcement
Class II
·Ongoing·Draeger Medical Systems, Inc.·July 20, 2022
Infinity Central Station. Model Number: MS26800 The Infinity CentralStation (ICS) is intended for centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment. Centralized monitoring involves the display and management of data from networked patient monitors including the annunciation of visual and audible physiologic parameter alarms at a central monitoring workstation.
FDA Enforcement
Class II
·Ongoing·Draeger Medical Systems, Inc.·February 5, 2025
Draeger Infinity M300 and M300+, for use with the ICS to monitor ECG and pulse oximetry on ambulatory and non-ambulatory adult and pediatric patients using wireless communication over the Infinity patient monitoring network,
FDA Enforcement
Class II
·Ongoing·Draeger Medical Systems, Inc.·May 3, 2023
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 8888102004HP
FDA Enforcement
Class I
·Ongoing·Covidien LP·August 23, 2023
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, IC Tray REF: 8888101004HP
FDA Enforcement
Class I
·Ongoing·Covidien LP·August 23, 2023
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, IC Tray REF:8888101001HP
FDA Enforcement
Class I
·Ongoing·Covidien LP·August 23, 2023
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, IC Tray REF: 8888101002HP
FDA Enforcement
Class I
·Ongoing·Covidien LP·August 23, 2023