15 results
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8ms
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Sources: EU EUDAMED, US FDA
Willy Rusch GmbH Tracheostomy Tube Set Cannulation of tracheotomised patients, particularly in the case of a narrow tracheostoma and narrow-lumen tracheas. When using cannulas with curr. For short term intermittent inflation.
FDA Enforcement
Class I
·Terminated·Teleflex Medical·October 26, 2016
Vyaire Medical GmbH, Vyaire Twin Tube sample line 240 cm, Model Number V-707327; The TwinTube sample line 240cm is used in the Vyntus CPX. The TwinTube sample line 240cm is connected to the adapter for DVT. Twin Tube Probenschlauch (707004), which is sold outside the US only. Used in breath analysis for metabolic response study.
FDA Enforcement
Class I
·Ongoing·Vyaire Medical, Inc.·May 15, 2024
Sheath, 20 Fr., 130 mm (REF: WA2PS20S), gastroenterology-urology endoscopic access overtube.
FDA Enforcement
Class I
·Ongoing·Trokamed GmbH·January 22, 2025
Sheath, 18 Fr., 130 mm (REF: WA2PS18S), gastroenterology-urology endoscopic access overtube.
FDA Enforcement
Class I
·Ongoing·Trokamed GmbH·January 22, 2025
Sheath, 18 Fr., 160 mm (REF: WA2PS18L), gastroenterology-urology endoscopic access overtube.
FDA Enforcement
Class I
·Ongoing·Trokamed GmbH·January 22, 2025
Sheath, 20 Fr., 160 mm (REF: WA2PS20L), gastroenterology-urology endoscopic access overtube.
FDA Enforcement
Class I
·Ongoing·Trokamed GmbH·January 22, 2025
EXCOR Pediatric Ventricular Assist Device Blood Pumps, Models: P10P-001 (10 ml blood pump); P15P-001 (10 ml blood pump); P25P-001x01 (25 ml blood pump); P30P-001x01 (30 ml blood pump), P50P-001 (50 ml blood pump); P60P-001 (60 ml blood pump). Recall occurred in 2018, and was retrospectively reported.
FDA Enforcement
Class I
·Terminated·BERLIN HEART GMBH·May 31, 2023
GE Healthcare Pediatric Direct-Wired Disposable Defibrillation/Pacing Electrodes. REF 2059144-001 and 2059144-005. . Product Usage: Usage: Skintact Pediatric Multifunction Electrodes are for use on pediatric patients, less than 8 years of age, or weighing less than 25 kg (55 lbs), for external defibrillation, pacing, monitoring and cardioversion. The device is non-sterile and for single use only.
FDA Enforcement
Class I
·Terminated·Leonhard Lang Gmbh·December 31, 2014
CentriMag Acute Circulatory Support System Motor, U.S. Model 102956 and OUS Model 201-10002, a component of the CentriMag Extracorporeal Blood Pumping System.
FDA Enforcement
Class I
·Terminated·Thoratec Switzerland GMBH·November 6, 2019
Skintact Electrode for Defibrillation, Pacing, Monitoring, Cardioversion. Product Usage: Multifunction electrode for external defibrillation, pacing, cardioversion, and monitoring. The device is non-sterile and for single use only. Used with automated external defibrillators
FDA Enforcement
Class I
·Terminated·Leonhard Lang Medizintechnik GmbH·September 20, 2017
Skintact Electrodes for Defibrillation, DF29N. Product Usage: Multifunction electrode for external defibrillation, pacing, cardioversion, and monitoring. The device is non-sterile and for single use only.
FDA Enforcement
Class I
·Terminated·Leonhard Lang Medizintechnik GmbH·October 26, 2016
DORO LUCENT Base Unit, REF 1101.021 Headrest System used in open and percutaneous craniotomies and spinal surgeries
FDA Enforcement
Class I
·Terminated·Pro-Med Instruments Gmbh·September 26, 2018
DORO LUCENT Locking Transitional Member, REF 1101.031 Component of headrest system used in open and percutaneous craniotomies and spinal surgeries
FDA Enforcement
Class I
·Terminated·Pro-Med Instruments Gmbh·September 26, 2018
DORO LUCENT Transitional Member, REF 1101.026 Component of headrest system used in open and percutaneous craniotomies and spinal surgeries
FDA Enforcement
Class I
·Terminated·Pro-Med Instruments Gmbh·September 26, 2018
Pediatric care bed; Product Designation: KayserBett IDA;
FDA Enforcement
Class I
·Ongoing·KAYSERBETTEN GMBH & CO. KG·June 10, 2026