14 results
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17ms
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Sources: EU EUDAMED, US FDA
Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-05400-CA1
FDA Enforcement
Class II
·Terminated·Arrow International Inc·February 26, 2020
FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05400-CA1
FDA Enforcement
Class II
·Terminated·Arrow International Inc·February 19, 2020
NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3
FDA Enforcement
Class II
·Terminated·Fresenius Medical Care Holdings, Inc.·July 13, 2022
Contra-Angles CA1:1L EVO 15 Catalog numbers: 1600939-001 and 1600938-001 Used for generally dentistry procedures
FDA Enforcement
Class II
·Terminated·Bien Air Dental SA·September 30, 2015
Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1003
FDA Enforcement
Class II
·Terminated·Kelyniam Global, Inc.·May 23, 2018
PSI Knee System- Prosthesis, knee patellofemorotibial, semi-constrained, cemented, polymer/meal/polymer The Zimmer PSI Knee System is indicated as an orthopedic instrument system to assist in the positioning of knee replacement components.
FDA Enforcement
Class II
·Terminated·Zimmer CAS·December 10, 2014
Tibial Alignment Guide; Orthopedic Stereotaxic Instrument;
FDA Enforcement
Class II
·Terminated·Zimmer CAS·June 10, 2015
POM Procedural Oxygen Masks, Endoscopic, Conscious Sedation, Bronchoscopy Mask, as follows: (1) POM Medical, LLC, REF 1001-MM, High/Med Concentrations, Distributed by POM Medical, LLC, Moorpark, CA; (2) curaplex, REF 301-0318LT, Medium Concentration, Distributed by Sarnova HC, LLC's family of companies: Bound Tree Medical, LLC, Cardio Partners, Inc., Emergency Medical Products, Inc. & Tri-anim Health Services, Inc., Dublin, OH; and (3) POM Medical, LLC REF 1001-MF, High/Med Concentrations, Distributed by POM Medical, LLC, Moorpark, CA. All are packaged 1 mask/plastic pouch, 30 masks/case.
FDA Enforcement
Class II
·Terminated·POM Medical LLC·November 6, 2019
Varian brand Clinac, Trilogy, Novalis Tx, Unique, linear accelerators; Model Number: H14, H18, H29, Reference/FSCA Identifier: CP-08881; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA. 1) The Varian Low Energy Linear Accelerator is indicated for precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment i is indicated. (2) The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc. Oncology Systems·September 26, 2012
SmartTools Knee System Orthopedic Stereotaxic Instrument
FDA Enforcement
Class II
·Terminated·Orthosoft, Inc. dba Zimmer CAS·April 26, 2017
Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument CAS Software application intended to assist in the placement of total knee replacement components
FDA Enforcement
Class II
·Terminated·Orthosoft, Inc. dba Zimmer CAS·May 3, 2017
Navitrack System - OS Knee Universal, Stereotaxic instrument
FDA Enforcement
Class II
·Terminated·Orthosoft, Inc. dba Zimmer CAS·May 24, 2017
Sesamoid Plasty, Stereotaxic Instrument The Sesamoid Plasty workstation is used to run the tracking software as part of the software based navigation systems. The affected Sesamoid Plasty components are the central structural column and its base that hold up the computer and the tracking camera on the Sesamoid Plasty workstation. They are also designed to be disassembled such that the column can be folded onto itself for ease of transport after use. This is a retrospective recall report for a removal initiated on 17 June 2008
FDA Enforcement
Class II
·Terminated·Orthosoft, Inc. dba Zimmer CAS·June 14, 2017
NDI P7 Position Sensor, Stereotaxic Instrument
FDA Enforcement
Class II
·Terminated·Orthosoft, Inc. dba Zimmer CAS·May 17, 2017