18 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NuVasive X-CORE(R) Expandable VBR System
FDA 510(k)
FDA Class 2
·Orthopedic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814688·GENUMEDI SILVER SIZE V
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04047872666534·PT CONTROL II GREY LEFT XL
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526550148·GENUMEDI PT KNEE SUP SILVER L EW V
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690192817·20mm X 150mm Stem Pilot
Vilex Power Accessory
FDA UDI
VILEX IN TENNESSEE, INC.·00841731122247·KWire .054x9" (1.4x225mm)
BONE FUSION PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SNORERX 9.0
FDA 510(k)
FDA Class 2
·Dental
BATHLIFT BLISS RECLINER US AB
FDA Adverse Event
Malfunction
·HANDICARE·Product code FNG·May 23, 2013
CSF-FLOW CONTROL VALVE, ULTRA SMALL, MEDIUM PRESSURE
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROSURGERY·Product code JXG·May 26, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 3, 2008
da Vinci S Surgical System IS2000, Disposable Accessory Kit, 3 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·April 15, 2015
da Vinci S Surgical System IS2000, Disposable Accessory Kit, 4 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·April 15, 2015
STA-R blood coagulation analyzer. Catalog Number 57160.
FDA Recall
Terminated
·Diagnostica Stago, Inc.·Product code JPA·June 20, 2005
da Vinci S / Si Surgical System IS2000 / IS3000, Camera Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·April 15, 2015
da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 4 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·April 15, 2015
da Vinci Si Surgical System IS3000, Camera Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·April 15, 2015
da Vinci S / Si Surgical System IS2000 / IS3000, Instrument Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·April 15, 2015