83 results
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11ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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ProBeam Proton Therapy System (HGA and HFB) Product Usage:ProBeam Proton Therapy System provides protons for precision radiotherapy of lesions, tumors, and conditions anywhere in the body. where radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·VARIAN MEDICAL SYSTEMS PARTICLE THERAPY GMBH·July 2, 2014
ProBeam Proton Therapy System (HGA and HFB) Product Usage:ProBeam Proton Therapy System provides protons for precision radiotherapy of lesions, tumors, and conditions anywhere in the body. where radiation treatment is indicated.
FDA Recall
Terminated
·VARIAN MEDICAL SYSTEMS PARTICLE THERAPY GMBH FRIEDRICH-EBERT-STR. 1 BERGISCH GLADBACH Germany·Product code LHN·May 9, 2014
Human Fetal Hemoglobin (HBF-1) FITC Conjugate
FDA Enforcement
Class II
·Terminated·Life Technologies Corporation·April 25, 2018
Newport HT50 Ventilator. Model #HT50 H1-B The device is intended to provide continuous or intermittent mechanical ventilator support for the care of individuals who require mechanical ventilation. Specifically, the NEWPORT HT50 is applicable for adult and pediatric (i.e. infant, child and adolescent) patients, greater than or equal to 10 kg (22 Ibs), who require the following general types of ventilatory support.
FDA Recall
Terminated
·Newport Medical Instruments Inc·Product code CBK·January 13, 2009
Newport HT50 Ventilator. Model No. HT50-H, HT50-HB, HT50-H1, and HT50-H1B. The device is intended to provide continuous or intermittent mechanical ventilator support for the care of individuals who require mechanical ventilation. Specifically, the NEWPORT HT50 is applicable for adult and pediatric (i.e. infant, child and adolescent) patients, greater than or equal to 10 kg (22 Ibs)
FDA Recall
Terminated
·Newport Medical Instruments Inc·Product code CBK·May 14, 2010
Newport HT50 Ventilator, Model # HT-50-H, HT50-HB, HT50-H1, and HT50-H1B Product Code: NOU The device is intended to provide continuous or intermittent mechanical ventilator support for the care of individuals who require mechanical ventilation. Specifically, the NEWPORT HT50 is applicable for adult and pediatric (i.e. infant, child and adolescent) patients, greater than or equal to 10 kg (22Ibs), who require the following general types of ventilatory support: positive pressure ventilation with Assist/Control, SIMV and SPONT/CPAP modes of ventilation. The NEWPORT HT50 is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician; it is suitable for use in hospital, sub-acute, emergency room, and home care environments, as well as for transport and emergency response applications.
FDA Recall
Terminated
·Newport Medical Instruments Inc·Product code CBK·July 22, 2009
Lynx TM20 Torquemaster Low Speed Handpiece MTI Dental Products
FDA Recall
Terminated
·MTI Precision Products LLC.·Product code EFB·May 7, 2012
Midwest XGT High Speed Handpiece with Fiber Optics and Push Button Chuck, catalog #790000; Manufactured for DENTSPLY Professional, A Division of DENTSPLY International, 901 West Oakton Street, Des plaines, IL 60018-1884 USA
FDA Recall
Terminated
·DentSply Professional Division·Product code EFB·October 14, 2003
Smith & Nephew Dyonics Saw Blade, Long, Special, Product Number 3706
FDA Recall
Terminated
·Smith & Nephew, Inc.·Product code HAB·February 2, 2017
DYONICS POWER Shaver Blades, 4.5mm Long Curved Full Radius Convex, package of 3. Catalog Number: 7205336 Product Usage: Smith & Nephew DYONICS Disposable Endoscopic Blades are indicated for resection of soft and osseous tissues in both large and small articular cavities.
FDA Recall
Terminated
·Smith & Nephew, Inc. Endoscopy Division·Product code HAB·May 6, 2011
Diamond Coated Tips and Burs are accessories to the air powered dental handpiece (S-MAX pico) The intended use of the tips is based on the parent device. For burs used with the dental handpieces, the intended use is general dental actions such as removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.
FDA Recall
Terminated
·Nakanishi Inc. 700 Shimohinata Kanuma Japan·Product code EFB·July 8, 2016
Smith & Nephew Dyonics Saw Blade, Short, Product Number 3703
FDA Recall
Terminated
·Smith & Nephew, Inc.·Product code HAB·February 2, 2017
Smith & Nephew Dyonics Saw Blade, Narrow, Product Number 3705
FDA Recall
Terminated
·Smith & Nephew, Inc.·Product code HAB·February 2, 2017
Biomet Stablecut Saw Blade - Reprocessed Sterile device -- Powered Saw and Accessories.
FDA Recall
Terminated
·Ascent Healthcare Solutions, Inc.·Product code HAB·March 11, 2008
Smith & Nephew Dyonics Saw Blade, Standard, Product Number 3701
FDA Recall
Terminated
·Smith & Nephew, Inc.·Product code HAB·February 2, 2017
DYONICS POWER Shaver Blades, 4.5mm Long Full Radius, package of 3 Catalog Number: 7205341 Product Usage: Smith & Nephew DYONICS Disposable Endoscopic Blades are indicated for resection of soft and osseous tissues in both large and small articular cavities.
FDA Recall
Terminated
·Smith & Nephew, Inc. Endoscopy Division·Product code HAB·May 6, 2011
Smith & Nephew Dyonics Saw Blade, Short, Narrow, Product Number 3704
FDA Recall
Terminated
·Smith & Nephew, Inc.·Product code HAB·February 2, 2017
Midwest Tradition PB Fiber Optic High Speed Handpiece with Push Button Chuck (5 tube connection), catalog #790045 and 790045T; Manufactured for DENTSPLY Professional, A Division of DENTSPLY International, 901 West Oakton Street, Des plaines, IL 60018-1884 USA
FDA Recall
Terminated
·DentSply Professional Division·Product code EFB·October 14, 2003
Stryker Oscillating & Sagittal Blade - Reprocessed Sterile device -- Powered Saw and Accessories.
FDA Recall
Terminated
·Ascent Healthcare Solutions, Inc.·Product code HAB·March 11, 2008
Smith & Nephew Dyonics Saw Blade, Standard, Thick, Product Number 3702
FDA Recall
Terminated
·Smith & Nephew, Inc.·Product code HAB·February 2, 2017