15 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Veenstra Instruments VDC-506 Dose Calibrator
FDA 510(k)
FDA Class 2
·Radiology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814220·GENUMEDI PT SILVER L V
CoRoent
FDA UDI
Nuvasive, Inc.·00887517637536·CoRoent Ant TLIF PEEK, 14x12x32mm 15°
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814282·GENUMEDI PT SILVER R V
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704508482·SCISSORS LITTAUER SUTURE 5.5"
Vilex Power Accessory
FDA UDI
VILEX IN TENNESSEE, INC.·00841731122247·KWire .054x9" (1.4x225mm)
TROCHANTERIC NAIL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
IDRIVE SYSTEM (I DRIVE POWER HANDLE, IDRIVE (RALC) SINGLE USE RELOAD)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
530G INSULIN PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 5, 2014
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 3, 2013
BHR
FDA Adverse Event
Injury
·SMITH & NEPHEW ORTHOPAEDICS, LTD.·Product code NXT·June 28, 2011
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