58 results
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8ms
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Sources: EU EUDAMED, US FDA
DermaPen Pro Model, Micro Needling System, a motorized AC powered surgical instrument for dermabrasive use. Each motorized handpiece is packaged within a small box. Each disposable needle cartridge is packaged individually and then placed into boxes of 30 quantities per box.
FDA Enforcement
Class II
·Terminated·Derma Pen, LLC·September 16, 2015
Waterpik Sonic-Fusion Professional, Model: SF-02 Product Usage: The device is composed of a unit base and an oral irrigator/ battery operated brush power handle. The device provides a pulsating stream of potable water and/or powered toothbrush action to remove plaque and food particles from between the teeth and below the gum line. The power handle can also function as a rechargeable battery powered mechanical toothbrush.
FDA Enforcement
Class II
·Terminated·Water Pik, Inc.·August 15, 2018
Covidien Clearify Visualization System Item Code: 21-345 Intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope as well as clean the scope lens
FDA Enforcement
Class II
·Terminated·Medtronic·December 28, 2016
Signmoidoscope Product Usage: Intended to provide optical visualization of, therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Large Bowel to the Sigmoid Colon. The instrument is introduced via the rectum when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
FDA Enforcement
Class II
·Terminated·Pentax Medical Company·August 3, 2016
Duodenoscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, and Large Bowel to the Cecum. The instrument is introduced via the mouth or rectum as decided by the the anatomy being accessed when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
FDA Enforcement
Class II
·Terminated·Pentax Medical Company·August 3, 2016
Ultrasound Gastroscope Product Usage: Intended to provide optical visualization of, ultrasonic Visualization of, and therapeutic access to the Upper Gastrointestinal Tract including but not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, Small Bowel and underlying areas. The instrument is introduced via per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.
FDA Enforcement
Class II
·Terminated·Pentax Medical Company·August 3, 2016
Confocal GI Scope Product Usage: Intended to provide optical visualization of and therapeutic access to the Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, and Large Bowel to the Cecum. The instrument is introduced via the mouth or rectum as decided by the the anatomy being accessed when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
FDA Enforcement
Class II
·Terminated·Pentax Medical Company·August 3, 2016
Colonoscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Large Bowel to the Cecum. The instrument is introduced via the rectum when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
FDA Enforcement
Class II
·Terminated·Pentax Medical Company·August 3, 2016
Gastroscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach and Duodenum. The instrument is introduced via the mouth when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
FDA Enforcement
Class II
·Terminated·Pentax Medical Company·August 3, 2016
Custom Pak¿ (Custom Pak in which Alcon 25+¿ TOTALPLUS¿ Vitrectomy Pak is a component.) Includes all necessary items for a core vitrectomy procedure and connects to the CONSTELLATION Vision System.
FDA Enforcement
Class II
·Terminated·Alcon Research, LTD.·March 7, 2018
The Alcon Custom Pak. The Alcon Customer Pak is an assemblage of single-use medical devices and accessories designed by medical professionals for specific ophthalmic surgical procedures. Some Paks contain the Devon Light Glove.
FDA Enforcement
Class II
·Terminated·Alcon Research, Ltd.·June 10, 2015
Pad-Pak and Pedi-Pak accessories for the HeartSine Samaritan PAD 300P and 350P device (SAM 300P and 350P). Automated External Defibrillator electrode supplies. The Pedi-Pak is specifically designed for use with the HeartSine Samaritan PAD 300P and 350P device. It contains defibrillator electrodes in a sealed foil pouch and a battery pack in a sealed plastic housing.
FDA Enforcement
Class II
·Terminated·Heartsine Technologies, Limited·July 30, 2014
Alcon Custom Pak
FDA Enforcement
Class II
·Terminated·Alcon Research, LTD.·November 8, 2017
KimVent* Wet Pak* Closed Suction System for Adults, 14 F, DSE, MDI (Product 8224); KimVent* Wet Pak* Closed Suction System for Adults, 14 F, DSE (Product Code 22106); KimVent* Closed Suction System for Adults, 14 F, DSE, Wet Pak (Produce Code 221036) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.
FDA Enforcement
Class II
·Terminated·Halyard Health, Inc·September 9, 2015
KimVent* Wet Pak* Closed Suction System for Adults, 14 F, T-Piece (Product Code 22056); KimVent* Wet Pak* Closed Suction System for Adults, 16 F, T-Piece (Product Code 22556); KimVent* Wet Pak* Closed Suction System for Adults, 14 F, T-Piece (Product Code 22012356) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.
FDA Enforcement
Class II
·Terminated·Halyard Health, Inc·September 9, 2015
PAK 9733497 NAV NIM-SPINE PEDICLE ACC KT
FDA Enforcement
Class II
·Terminated·Medtronic Navigation, Inc.·November 26, 2014
eye-pak 7407 Tray Support Cover REF 8065740745
FDA Enforcement
Class II
·Terminated·Alcon Research, Ltd.·October 1, 2014
Wolf-Pak Premium Dressing Kit with GuardVA Cs/30 Ref: DC5030LF
FDA Enforcement
Class II
·Terminated·Trinity Sterile, Inc.·August 24, 2022
Humidifier Adaptor, 040 Shelf Pak, French, Teleflex Medical, respiratory gas humidifier adaptor.
FDA Enforcement
Class II
·Terminated·Teleflex Medical·July 16, 2014
Wolf Pak Premium Dressing Change Kit with Statlock CS/30 Ref: DC5040LF
FDA Enforcement
Class II
·Terminated·Trinity Sterile, Inc.·August 24, 2022