1,578 results
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13ms
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Sources: EU EUDAMED, US FDA
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
Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0
FDA Enforcement
Class I
·Terminated·Fresenius Kabi USA, LLC·October 12, 2022
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
PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981
FDA Enforcement
Class II
·Terminated·Ethicon, Inc.·July 25, 2018
CareFusion MaxPlus Clear Needleless Connector. Intended for Positive Displacement Connector for needleless access to the IV line and/or IV catheter during IV therapy Cat. No. MP1000-C
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·October 16, 2019