2,165 results
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7ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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2.5MM Aggressive Blade Known as a Sinuscopic Shaver Blade, this device is composed of a metal cutter and plastic drive shaft that goes into a metal housing supported by a plastic hub. ENT Precision Cutter, Aggressive, ESSxlHUMMER 4, Rx Only It is used for ENT procedures and functions by means of rotation when adapted to a handpiece and console. Through the rotation, the necessary tissue is resected as required by the user. The blade housing has an etching line guide that starts with a straight line and along with a scale from 1cm to 7cm in 1cm increments that serves the doctor as a guide by indicating how far the device is being introduced into the surgical area.
FDA Enforcement
Class II
·Terminated·Stryker Instruments Div. of Stryker Corporation·March 26, 2014
PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292
FDA Enforcement
Class II
·Terminated·Ethicon, Inc.·July 25, 2018
PRONOVA SUTURE BLUE 122CM M1.5, D10189
FDA Enforcement
Class II
·Terminated·Ethicon, Inc.·July 25, 2018
PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662
FDA Enforcement
Class II
·Terminated·Ethicon, Inc.·July 25, 2018
PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
FDA Enforcement
Class II
·Terminated·Ethicon, Inc.·July 25, 2018
PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688
FDA Enforcement
Class II
·Terminated·Ethicon, Inc.·July 25, 2018
PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
FDA Enforcement
Class II
·Terminated·Ethicon, Inc.·July 25, 2018
PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
FDA Enforcement
Class II
·Terminated·Ethicon, Inc.·July 25, 2018
PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
FDA Enforcement
Class II
·Terminated·Ethicon, Inc.·July 25, 2018
PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
FDA Enforcement
Class II
·Terminated·Ethicon, Inc.·July 25, 2018
10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM - Sterile: intended to treat stable and unstable fractures of the proximal femur
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·November 26, 2014
PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416
FDA Enforcement
Class II
·Terminated·Ethicon, Inc.·July 25, 2018
PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031
FDA Enforcement
Class II
·Terminated·Ethicon, Inc.·July 25, 2018
PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879
FDA Enforcement
Class II
·Terminated·Ethicon, Inc.·July 25, 2018
PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
FDA Enforcement
Class II
·Terminated·Ethicon, Inc.·July 25, 2018
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882476 - Gemini TF Big Bore PET/CT
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·July 7, 2021
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and MX16 Models: 728131
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·July 7, 2021
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882446 - Vereos PET/CT
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·July 7, 2021
PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748
FDA Enforcement
Class II
·Terminated·Ethicon, Inc.·July 25, 2018
PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
FDA Enforcement
Class II
·Terminated·Ethicon, Inc.·July 25, 2018