121 results
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15ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Hologic InPlex CF Molecular Test (IVD); Catalog Number: 95-432.
FDA Recall
Terminated
·Hologic, Inc·Product code NUA·March 31, 2016
CF InPlex ASR Card; Catalog Number: 95-0501.
FDA Recall
Terminated
·Hologic, Inc·Product code NUA·March 31, 2016
CF InPlex ASR Card; Catalog Number: 95-0501.
FDA Enforcement
Class II
·Terminated·Hologic, Inc·May 4, 2016
Hologic InPlex CF Molecular Test (IVD); Catalog Number: 95-432.
FDA Enforcement
Class II
·Terminated·Hologic, Inc·May 4, 2016
Applied Medical, Separator Abdominal Access System REF:C0605 15x100mm Threaded Separator System with Universal Seal, for laparoscopic procedures.
FDA Recall
Terminated
·Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa·Product code HET·June 25, 2008
(a) CareFusion Snowden-Pencer Plastics, Endoplastic Endoscope 10 mm, 30 degrees 7", 17.5 cm, Catalog #88-5910; (b) CareFusion Snowden-Pencer Plastics, Endoplastic Endoscope 5 mm, 30 degrees 7", 17.5 cm, Catalog #88-5920; (c) CareFusion Snowden-Pencer MIS, Endoplastic Fitting, Storz Scope, Catalog #88-9808; and (d) CareFusion Snowden-Pencer MIS, Endoplastic Fitting, Wolf Scope, Catalog #88-9809.
FDA Recall
Terminated
·Carefusion 2200 Inc
75 N Fairway Dr
Vernon Hills IL 60061-1845·Product code HET·February 23, 2022
Gynecare Morcellex Tissue Morcellator; Manufactured by: Ethicon Women's Health & Urology; A Division of ETHICON INC, a Johnson & Johnson Company, Somerville, NJ 08876
FDA Recall
Terminated
·Ethicon, Inc. US·Product code HET·September 28, 2009
Applied Medical, Separator Abdominal Access System REF: C0606 15x150mm Non-threaded Separator System with Universal Seal, for laparoscopic procedures.
FDA Recall
Terminated
·Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa·Product code HET·June 25, 2008
Instructions for Use for the blue endo MOREsolution Electromechanical Laparoscopic Morcellator System, Model 55-000011, consisting of the control unit, hand-grip, flexible shaft, trocars/obturators, sleeves, valves, and blades.
FDA Recall
Terminated
·Market-Tiers Inc·Product code HET·July 16, 2014
FlexTray Procedure Delivery System Endopath Gynecololgy Tray, Product #FN065.
FDA Recall
Terminated
·Ethicon Endo-Surgery·Product code HET·November 25, 2003
FlexTray Procedure Delivery System Endopath Gynecology Tray, Product #FD063.
FDA Recall
Terminated
·Ethicon Endo-Surgery·Product code HET·November 25, 2003
Guidant Brand VasoView 5 Harvesting Cannula System, Model Number: VH-1000
FDA Recall
Terminated
·Guidant Cardiac Surgery·Product code HET·November 19, 2003
Stryker brand Insufflation Tube Set and High Flow Insufflation Tube Set, Model Numbers: 620-030-201, 620-030-301
FDA Recall
Terminated
·Stryker Endoscopy·Product code HET·June 2, 2006
FlexTray Procedure Delivery System Endopath Gynecology Tray, Product #FD065.
FDA Recall
Terminated
·Ethicon Endo-Surgery·Product code HET·November 25, 2003
Olympus ENDOEYE HD II Video Telescopes. Models WA50040A ENDOEYE HD II, 10 mm, 0 degree, WA50042A ENDOEYE HD II 10 mm, 30 degree, W7100603 Repair cable 10 mm 0/30 degree. The ENDOEYE video Telescopes are used with other supporting equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including the female reproductive organs.
FDA Recall
Terminated
·Olympus Corporation of the Americas·Product code HET·November 17, 2015
Applied Medical, Separator Abdominal Access System REF: C0607 15x150mm Threaded Separator System with Universal Seal, for laparoscopic procedures.
FDA Recall
Terminated
·Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa·Product code HET·June 25, 2008
Applied Medical, Separator Abdominal Access System REF: C0604 15 x 100mm Non-threaded Separator System with Universal Seal, for laparoscopic procedures.
FDA Recall
Terminated
·Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa·Product code HET·June 25, 2008
Olympus ENDOEYE HD II Video Telescopes Models: WA50040A Endoeye HD II, 10 mm, 0 deg., autoclavable; WA50042A Endoeye HD II, 10 mm, 30 deg., autoclavable; repair cable 10mm 0/30 deg., part number W7100603
FDA Recall
Terminated
·Olympus Corporation of the Americas·Product code HET·February 10, 2017
Cardinal Health Jackson-Pratt Channel Drain 15FR, Full flutes, with trocar Product Number: JP-2189 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions.
FDA Recall
Terminated
·Degania Silicone, Ltd. Degania Bet Dganya Bet Israel·Product code GBX·June 28, 2019
Temperature sensing catheter 14FR, Catalogue Number 102201101463NU Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.
FDA Recall
Terminated
·Degania Silicone, Ltd. Degania Bet Dganya Bet Israel·Product code EZL·June 21, 2018