9 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Niobe ES System, Models 001-006000-1 and 001-006100-1
FDA Enforcement
Class II
·Terminated·Stereotaxis Inc·November 18, 2020
Savannah-T Straight Rod, 200mm, Part Number 10704-200; Savannah-T Straight Rod, 250mm, Part Number 10704-250; Savannah T-Straight Rod 300mm, Part Number 10704-300; Savannah-T Straight Rod, 400mm, Part Number 10704-400; Savannah-T Straight Rod, 500mm; Savannah-T High Top Straight Rod, 200mm; Savannah-T High Top Straight Rod, 220mm, Part Number 1705-220; Savannah-T High Top Straight Rod, 240mm, Product Code 10705-240; Savannah-T Straight Rod, 260mm, Part Number 10705-260; Savannah-T Straight Rod, 280mm, Part Number 10705-280; Savannah-T Straight Rod, 300mm, Part Number 10705-300; Savannah-T Notched Curved Rod, 200mm, Part Number 10706-200; Savannah-T Curve Rod, 200mm, Part Number 10707-200 The guide wire is passed through the cannulated handle of the Dual Stylet Needles and pressed into the bone
FDA Enforcement
Class II
·Terminated·Amendia, Inc·December 28, 2016
DynaCad software consist of an MR Analysis Server software and the viewer workstation software. The MR Analysis software consists of DynaCad Breast, DynaCad Prostate, and DynaCad Advanced PK for other MR analyses modules. Product Usage: Intended to be used as a post processing software package designed to provide a reliable means for analyzing MR datasets.
FDA Enforcement
Class II
·Terminated·Invivo Corporation·April 11, 2018
Omnidiagnost Classic, Product Codes 70859, 708023, 708024, 708025 Product Usage: The Philips OmniDiagnost is a multi-functional, universal X-ray system with remote-controlled facilities. It performs a wide range of routine examinations and interventional procedures include: Gastro-intestinal examination Urography Bronchography Arthrography Hysterography Myelography Lymphography Skeletal radiography Tomography Venography/phlebography Special procedures that require subtracted and non-subtracted digital imaginginclude: Angiography Peripheral angiography (bolus chasing) Vascular and non-vascular interventional procedures.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·April 3, 2019
URODiagnost Eleva, Product codes 708026, 708027, 708028 Product Usage: The Philips OmniDiagnost is a multi-functional, universal X-ray system with remote-controlled facilities. It performs a wide range of routine examinations and interventional procedures include: Gastro-intestinal examination Urography Bronchography Arthrography Hysterography Myelography Lymphography Skeletal radiography Tomography Venography/phlebography Special procedures that require subtracted and non-subtracted digital imaginginclude: Angiography Peripheral angiography (bolus chasing) Vascular and non-vascular interventional procedures.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·April 3, 2019
Siemens Medical Solutions, ACUSON P300 Ultrasound system with P300 PA 230E cardiac probe (Esaote product 7348). Provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·April 9, 2014
MultiDiagnost Eleva w/ Flat Detector, Product codes 708034, 708037, 708038 Product Usage: As a multifunctional I universal imaging application system, General RIF, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications on human patients. This includes the following general areas: Digestive system: Swallowing studies, Oesophagus, Stomach, Small intestine, Colon, Defeacography, ERCP, T-tube cholangiogram, Liver biopsies, Transjugular Intrahepatic Portosystemic Shunts (TIPS) Skeletal system: Bone studies. Urinary system: IVP, Cystograms, Percutaneous, Nephrolithotomy, Nephrostomy tube replacement Reproductive system: Hysterosalpingogram, Vena spermatica, Cavernography Respiratory system: Thorax, Bronchoscopy, Pulmonary biopsies Circulatory system: Venography, Arteriography, Thrombolytic Therapy, Em bolizations, Em bolectomy, IVC filter placement, Dilatations, Stent placement. Various: Arthrograms, Myelograms, Facet joint injections, Discography, Sialography.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·April 3, 2019
The LifeCare Pump Model 4200 PCA Infuser makes possible the practical implementation of patient-controlled analgesia. The health care professional sets the prescribed dose, rates, and limits for the drug to be infused. The infuser can be set to operate in one of three modes: PCA Mode, Continuous Mode, and PCA + Continuous Mode. The LifeCare Pump Model 4200 PCA Infuser is designed with a number of mechanical, electrical, and software safeguards that prevent patient injury or drug abuse.
FDA Enforcement
Class II
·Terminated·Hospira Inc.·July 20, 2016
Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare Inc·May 13, 2015