44 results
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7ms
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Sources: EU EUDAMED, US FDA
Philips Allura Xper FD20 Ceiling version only; 722028; imaging applications.
FDA Enforcement
Class II
·Terminated·Philips Electronics North America Corporation·February 17, 2016
Allura Xper FD OR Table, Ceiling version only; 722035; imaging applications.
FDA Enforcement
Class II
·Terminated·Philips Electronics North America Corporation·February 17, 2016
Universal Compact Head Ring Adapter Plate (UCHRAP), a component of the Universal Compact Head Ring Adapter, UCHRA. The UCHRA is a component of the Integra¿ CRW¿ Precision Arc Stereotactic System.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp.·October 14, 2015
Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage Arc (1053958). Neurological stereotaxic Instrument
FDA Enforcement
Class II
·Terminated·Elekta Inc·May 6, 2020
Milex Arcing Diaphragm Size 95; Model Number: MXWS95
FDA Enforcement
Class II
·Terminated·CooperSurgical, Inc.·March 16, 2016
Varian Multileaf Collimator [MLC]; Millenium Multileaf Collimator [52, 80, 120 leaf]; High Definition 120 Multileaf Collimator Model Number(s): product code: H54 and H56; MLC software version 8.5 - Product Usage: is intended to assist the clinician in the delivery of external beam radiation to defined target volumes during radiosurgery and radiotherapy while sparing surrounding normal tissue and critical organs from excess radiation.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·May 13, 2020
FOCAL Sim Workstation, Radiation Treatment Planning System. Used for patient contouring and viewing of treatment plan outputs. Also able to perform CT simulations and forward their information to the RTP System for dose calculation.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·September 10, 2014
Monaco The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon and electron treatment plans and displays, on-screen and in hard-copy, two or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·September 10, 2014
Apex Arc Hip Stem, Size 2, HA Coated; Product Code: HC-21002-HA
FDA Enforcement
Class II
·Terminated·Omnilife Science Inc.·August 27, 2014
Apex ARC Hip Stem, HA Coated, Size 5; Product Code: HC-21005-HA Product Usage: The Apex ARC Hip Stem is the femoral component of a primary or revision total hip replacement. This femoral hip stem is intended for press-fit application and is provided sterile for single use. They are manufactured from titanium alloy. The stem has a proximal porous coating of titanium plasma spray under a coating of hydroxyapatite (HA)
FDA Enforcement
Class II
·Terminated·Omnilife Science Inc.·July 22, 2015
OrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, REF ZBH-PSNCRCD39-L.
FDA Enforcement
Class II
·Terminated·Orthosensor, Inc.·October 17, 2018
OrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, REF ZBH-PSNCRCD39-R.
FDA Enforcement
Class II
·Terminated·Orthosensor, Inc.·October 17, 2018
Integra CRW Precision Arc (CRWPRECISE), CRW Arc System (CRWASL), HRAIM Head Ring Assembly with Intubation Mounts The CRW stereotactic system is used in conjunction with the HRAIM head ring is a target-centered system that can be configured to be CT-only or CTIMR compatible. The CRW stereotactic system is a multi-purpose system used for localizing intercranial targets for precisely directing instruments such as: Biopsy forceps RF lesioning electrodes Deep brain electrodes Recording and stimulating electrodes
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corporation·September 26, 2012
VerSys¿ Cemented Revision Calcar (CRC) Hip System Femoral Stems VerSys Heritage Hip System Revision Femoral Stems. Indicated for total hip arthroplasty.
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·November 20, 2013
System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·October 28, 2020
System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·October 28, 2020
System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·October 28, 2020
System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·October 28, 2020
Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance - Product Usage: The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and / or PET imaging.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·October 28, 2020
SafeAir Telescopic Smoke Evacuation Pencil, Product No. 0703 046 004. The product is a Bovie pencil that is 75 inches long compressed, with a telescoping shaft. UDI GTIN 37613327466332
FDA Enforcement
Class II
·Terminated·Stryker Instruments Div. of Stryker Corporation·February 12, 2020