13 results
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15ms
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Sources: EU EUDAMED, US FDA
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