12 results
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7ms
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Sources: EU EUDAMED, US FDA
Pediatric care bed; Product Designation: KayserBett IDA;
FDA Enforcement
Class I
·Ongoing·KAYSERBETTEN GMBH & CO. KG·June 10, 2026
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
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
Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereotactic. Radiology Departments. The BrainLAB Cranial IGS System is intended to be an intra-operative image guided localization system to enable minimally invasive surgery.
FDA Enforcement
Class I
·Terminated·Brainlab AG·January 27, 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
Spine & Trauma 3D Navigation 1.0 (subpart of the system Navigation Software Spine & Trauma 3D, Version 3.0 ) Intended Use The Spine & Trauma Navigation System is intended as an intraoperative image-guided localization system to enable minimally invasive surgery.
FDA Enforcement
Class I
·Terminated·Brainlab AG·April 24, 2019