25 results
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Sources: EU EUDAMED, US FDA
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DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that come in two sizes (3.75mm and 6.35mm) containing: 1. DKS Large Obturator Trocar (Model Number 330.017) 2. DKS Large Lighted Cannula (Model Number 330.011) 3. DKS Large Kerrison (330.015) 4. DKS Small Obturator Trocar (330.013) 5. DKs Small Lighted Cannula (330.014) 6. DKS Small Kerrison (330.016)
FDA Enforcement
Class II
·Ongoing·Folsom Metal Products, Inc.·December 18, 2024
KLS Martin Battery Pack, REF: KLS BP2 001, and KLS BP2 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver 2.0 surgical driver, REF: KLS-SD-2000
FDA Enforcement
Class II
·Ongoing·Pro-Dex Inc·November 6, 2024
Small DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that come in two sizes (3.75mm and 6.35mm) containing: 1. DKS Small Obturator Trocar (Model Number 330.013) 2. DKs Small Lighted Cannula (Model Number 330.014) 3. DKS Small Kerrison (330.016)
FDA Enforcement
Class II
·Ongoing·Folsom Metal Products, Inc.·December 18, 2024
KLS Martin Battery Pack, REF: KLS BP 001, and KLS BP 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver
FDA Enforcement
Class II
·Ongoing·Pro-Dex Inc·July 12, 2023
Battery Pack KLS-SD-1000 Single Models: KLS-BP-001 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver).
FDA Enforcement
Class II
·Terminated·Pro-Dex Inc·March 23, 2016
Battery Pack KLS-SD-1000 Case (40 ct) Models: KLS-BP-040 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver).
FDA Enforcement
Class II
·Terminated·Pro-Dex Inc·March 23, 2016
KLS martin Group KLS E-COUPLING ADAPTER REF PDEC-1000-2 E-Coupling Adapter Assembly used to connect the KLS driver (e.g. drill) to a driver bit that fits into the adapter.
FDA Enforcement
Class II
·Ongoing·Pro-Dex Inc·April 26, 2023
OEC UroView 2800, fluoroscopic x-ray system
FDA Enforcement
Class II
·Terminated·GE OEC Medical Systems, Inc·August 31, 2016
OEC 9800, fluoroscopic x-ray system
FDA Enforcement
Class II
·Terminated·GE OEC Medical Systems, Inc·August 31, 2016
ACL TOP 700 LAS, automated coagulation laboratory instrument.
FDA Enforcement
Class II
·Terminated·Instrumentation Laboratory Co.·July 23, 2014
Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle dependent upon device in use 100 - 240 VAC, 50/60HZ, 16 AM
FDA Enforcement
Class II
·Ongoing·Spectranetics Corporation·July 20, 2022
IontoPatch 80, On-the-Go Patch Therapy, Model/Catalog Number: D-0077-080; The IontoPatch is an Iontophoresis transdermal patch.
FDA Enforcement
Class II
·Ongoing·LTS Therapy Systems, LLC·August 6, 2025
IontoPatch STAT, On-the-Go Patch Therapy, Model/Catalog Number D-0062-080; IontoPatch is an Iontophoresis transdermal patch.
FDA Enforcement
Class II
·Ongoing·LTS Therapy Systems, LLC·August 6, 2025
Philips Laser System, REF: LAS-100. Used in minimally invasive interventional procedures within the cardiovascular system, and for the removal of problematic pacemaker and defibrillator cardiac leads.
FDA Enforcement
Class II
·Ongoing·Spectranetics Corporation·November 23, 2022
Siemens CentraLink Data Management System, software version 14. The CentraLink system software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·September 24, 2014
ACL TOP 700 LAS; PN 0000280030 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.
FDA Enforcement
Class II
·Terminated·Instrumentation Laboratory Co.·September 25, 2013
CentraLink" Data Management System; software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab. The CentraLink software consolidates data from all connected instruments so that an operator can review and edit patient and quality control results from a single location.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·July 8, 2015
Instrumentation Laboratory ACL TOP 700 LAS PN 0000280030 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters
FDA Enforcement
Class II
·Terminated·Instrumentation Laboratory Co.·September 26, 2012
Siemens CentraLink" Data Management System V14.0.4, V14.0.5 or V14.0.8 The CentraLink system software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab. The CentraLink software consolidates data from all connected instruments so that an operator can review and edit patient and quality control results from a single location.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·January 29, 2014
ADVIA Chemistry XPT interfaced to the CentraLink Data Management System V14x in specific configurations: The CentraLink system software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab. The CentraLink software consolidates data from all connected instruments so that an operator can review and edit patient and quality control results from a single location.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·January 21, 2015