10,000 results
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular Support Systems (cardiovascular)
FDA Recall
Terminated
·Abiomed, Inc.·Product code OZD·March 1, 2021
Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular Support Systems (cardiovascular)
FDA Enforcement
Class II
·Terminated·Abiomed, Inc.·February 28, 2024
Aesculap Inc.(AIC) Miethke Ventricular Catheter with Deflector/Miethke Shunt System The Miethke Shunt System is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.
FDA Recall
Terminated
·Aesculap, Inc.·Product code JXG·April 21, 2014
Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1.
FDA Recall
Terminated
·Abiomed, Inc.·Product code OZD·October 10, 2023
Automated Impella Controller (AIC), product number 0042-000-US with software versions V8.4 and V8.4.1.
FDA Recall
Terminated
·Abiomed, Inc.·Product code OZD·October 10, 2023
Aesculap Inc.(AIC) Miethke Ventricular Catheter with Deflector/Miethke Shunt System The Miethke Shunt System is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.
FDA Enforcement
Class II
·Terminated·Aesculap, Inc.·June 11, 2014
Vein Irrigation Cannula with blunt tip. ASY BIC, STERILE 25/CS REF/ GTIN for Insert Label:BIC/ 00803622133091
FDA Recall
Terminated
·LivaNova USA Inc.·Product code DWF·April 24, 2020
Automated Impella Controller (AIC), product number 0042-000-US with software versions V8.4 and V8.4.1.
FDA Enforcement
Class II
·Terminated·Abiomed, Inc.·December 13, 2023
Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1.
FDA Enforcement
Class II
·Terminated·Abiomed, Inc.·December 13, 2023
Vein Irrigation Cannula with blunt tip. ASY BIC, STERILE 25/CS REF/ GTIN for Insert Label:BIC/ 00803622133091
FDA Enforcement
Class II
·Terminated·LivaNova USA Inc.·July 8, 2020
Aesculap Miethke Shunt System, miniNAV Valve: The Miethke Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum.
FDA Enforcement
Class III
·Terminated·Aesculap, Inc.·December 24, 2014
Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item # 3456102A The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a Physician. The following types of renal replacement therapy can be carried out with the system: Hemodialysis (HD) with or without phases of pure ultrafiltration, High flux hemodialysis and low flux hemodialysis.
FDA Enforcement
Class I
·Terminated·B Braun Medical Inc·May 11, 2016
Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item 3456103A The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a Physician. The following types of renal replacement therapy can be carried out with the system: Hemodialysis (HD) with or without phases of pure ultrafiltration, High flux hemodialysis and low flux hemodialysis.
FDA Enforcement
Class I
·Terminated·B Braun Medical Inc·May 11, 2016
The Dual Switch Valve is used for fluid drainage from the ventricles into the peritoneum, in cases of hydrocephalus.
FDA Enforcement
Class II
·Terminated·Aesculap, Inc.·December 10, 2014
Aesculap Miethke Shunt System, miniNAV Valve: The Miethke Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum.
FDA Recall
Terminated
·Aesculap, Inc.·Product code JXG·November 11, 2014
Dafilon Suture Black 10/0 (0.2) 15 cm DRM4 NS, non-sterile, non-absorbable polyamide Surgical Suture, additional label affixed on the box states the product is sterile, packaged in a cassette holding 12 sutures
FDA Enforcement
Class II
·Terminated·Aesculap, Inc.·July 16, 2014
Dialog+ Hemodialysis machines: Dialog A + HE/BIC Product Code 710200L Serial # >200318 and < 2039222 The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a Physician. The following types of renal replacement therapy can be carried out with the system: Hemodialysis (HD) with or without phases of pure ultrafiltration, High flux hemodialysis and low flux hemodialysis.
FDA Enforcement
Class I
·Terminated·B Braun Medical Inc·May 11, 2016
Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL-BIC Product Code # 710200U Serial # 202136 and < 203837 The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a Physician. The following types of renal replacement therapy can be carried out with the system: Hemodialysis (HD) with or without phases of pure ultrafiltration, High flux hemodialysis and low flux hemodialysis.
FDA Enforcement
Class I
·Terminated·B Braun Medical Inc·May 11, 2016
Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Conductivity Sensor (BIC) - VERSION 2, Article Code Number 3456102A. These conductivity sensors may be used as spare parts for the following dialysis machines: 710200L (UDI 04046963686345), 710200S (UDI 04046964285608), 710200U (UDI 04046964285615), 710200K (UDI 04046963686338), 710500L (UDI Not applicable) and 710500K (UDI Not applicable).
FDA Enforcement
Class II
·Terminated·B Braun Medical Inc·April 20, 2022
The Dual Switch Valve is used for fluid drainage from the ventricles into the peritoneum, in cases of hydrocephalus.
FDA Recall
Terminated
·Aesculap, Inc.·Product code JXG·October 24, 2014