607 results
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21ms
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Sources: EU EUDAMED, US FDA
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StoneBreaker Exhaust Line, Catalog number: SBA-EL; GPN: G52600; UDI: (01)00827002526006
FDA Enforcement
Class II
·Terminated·Cook Inc.·May 9, 2018
StoneBreaker Exhaust Cap, Catalog number: SBA-EC; GPN: G52599; UDI: (01)00827002525993
FDA Enforcement
Class II
·Terminated·Cook Inc.·May 9, 2018
StoneBreaker Sterilization Cap, Catalog number: SBA-SC; GPN: G52602; UDI: (01)00827002526020
FDA Enforcement
Class II
·Terminated·Cook Inc.·May 9, 2018
ANSPACH - 4MM x 11 MM Fluted Barrel, 14 Flutes; REF M-4BA-A-G1. Cutting shaping bone including spine and cranium.
FDA Enforcement
Class II
·Terminated·The Anspach Effort, Inc.·August 5, 2015
ANSPACH - 5MM x 11.3MM Fluted Barrel; REF M-5BA-A-G1 Cutting shaping bone including spine and cranium.
FDA Enforcement
Class II
·Terminated·The Anspach Effort, Inc.·August 5, 2015
FlexLab (FLX); Version: FLX-217-10;
FDA Enforcement
Class II
·Ongoing·Inpeco S.A.·December 3, 2025
FlexLab (FLX); Version: FLX-217-40;
FDA Enforcement
Class II
·Ongoing·Inpeco S.A.·December 3, 2025
FlexLab (FLX) System. Potassium Test System. in vitro diagnostic
FDA Enforcement
Class II
·Ongoing·Inpeco S.A.·October 15, 2025
FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic
FDA Enforcement
Class II
·Ongoing·Inpeco S.A.·October 15, 2025
ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.
FDA Enforcement
Class II
·Ongoing·TERRAGENE S.A.·March 5, 2025
The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring intracranial ventricular pressure with tunneling (PSO-VT) indicated for use in intraventricular pressure monitoring and cerebrospinal fluid drainage application. Model/Catalog Number: PSO-VT
FDA Enforcement
Class II
·Ongoing·Sophysa S.A.·May 22, 2024
The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring intracranial ventricular pressure and temperature with tunneling (PSO-VTT) indicated for use in intraventricular pressure monitoring and cerebrospinal fluid drainage application. Model/Catalog Number: PSO-VTT
FDA Enforcement
Class II
·Ongoing·Sophysa S.A.·May 22, 2024
Large Stealth Chamber, Catalog Numbers: DS50-001-XL-T, DS50-002-XL-T, DS50-003-XL-T, DS50-102-XL-T, DS50-103-XL-T
FDA Enforcement
Class II
·Terminated·Iba Dosimetry·June 14, 2017
TDHistology/Cytology Classification name: Calculator/data processing module for clinical use (862.2100). Intended use: Laboratory Information System (L.I.S)
FDA Enforcement
Class III
·Terminated·Technidata S.A.·July 24, 2013
TD-Synergy. Laboratory Information System.
FDA Enforcement
Class II
·Terminated·Technidata S.A.·May 29, 2013
Punch Hair Matic A surgical hair transplant device designed for automation of follicular transplantation.
FDA Enforcement
Class II
·Terminated·MEDICAMAT S.A.·March 12, 2014
FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2), Laboratory Automation System
FDA Enforcement
Class II
·Terminated·Inpeco S.A.·May 16, 2018
RadPro 40kW Digital X-Ray Panel and Mobile/Portable Diagnostic X-Ray. Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts.
FDA Enforcement
Class II
·Terminated·Sedecal S.A.·August 26, 2015
TDWorkstation version 11.01.A or higher. TDWorkstation Evolution. TDWorkstation receives patient results from a connected instrument and sends them to a Laboratory Information System (LIS).
FDA Enforcement
Class III
·Terminated·Technidata S.A.·April 9, 2014
MobileDiagnost wDR motorized portable diagnostic X-ray systems.
FDA Enforcement
Class II
·Terminated·Sedecal S.A.·February 11, 2015