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Sources: EU EUDAMED, US FDA
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Pinook Micro Massager Distributed by www.pinookusa.com Used to strengthen the abdominal muscles.
FDA Recall
Terminated
·Pinook-Usa·Product code NGX·May 23, 2013
Pinook Mini Massager Distributed by www.pinookusa.com. Used to strengthen the abdominal muscles.
FDA Recall
Terminated
·Pinook-Usa·Product code NGX·May 23, 2013
Sealapex Xpress, Part No. 33639 The brand name of the device is Sealapex Xpress, a root canal filling resin. Sealapex Xpress is intended to be used during endodontic therapy to fill the root canal of a tooth.
FDA Recall
Terminated
·Ormco/Sybronendo·Product code KIF·August 31, 2016
Sealapex Express (Part Number: 33639), root canal filling material. Manufactured by SybronEndo, Glendora, CA. Intended as a root canal filling material that is used in conjunction with gutta percha or silver endodontic points.
FDA Recall
Terminated
·Sybron Dental Specialties·Product code KIF·February 23, 2009
Philips Respironics V60 Ventilator Part Number R1053618 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
FDA Enforcement
Class II
·Terminated·Respironics California, LLC·February 3, 2021
Philips Respironics V60 Ventilator Part Number 1076717 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
FDA Enforcement
Class II
·Terminated·Respironics California, LLC·February 3, 2021
Philips Respironics V60 Ventilator Part Number U1053617 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
FDA Enforcement
Class II
·Terminated·Respironics California, LLC·February 3, 2021
Philips Respironics V60 Ventilator Part Number 1053616 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
FDA Enforcement
Class II
·Terminated·Respironics California, LLC·February 3, 2021
Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For treatment of vascular aneurysms.
FDA Recall
Terminated
·Medtronic Vascular, Inc.·Product code MIH·April 28, 2021
Philips Respironics V60 Ventilator Part Number DU1053617 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
FDA Enforcement
Class II
·Terminated·Respironics California, LLC·February 3, 2021
Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For treatment of vascular aneurysms.
FDA Enforcement
Class II
·Terminated·Medtronic Vascular, Inc.·July 7, 2021
Philips Respironics V60 Ventilator Part Number 1053618 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
FDA Enforcement
Class II
·Terminated·Respironics California, LLC·February 3, 2021
Fancy i Color cosmetic lens, Contents: A pair of sterile soft color contact lens immersed in buffered isotonic saline solution, Size: B.C. 8.6mm DIA. 14.5mm. Dreamcon Co. LTD. Korea.
FDA Recall
Terminated
·Kim's Trading Inc·Product code LPM·May 17, 2010
Philips Respironics V60 Ventilator Part Number 1137292 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
FDA Enforcement
Class II
·Terminated·Respironics California, LLC·February 3, 2021
PT113950 PT HYBRID Glenoid Post Regenerex porous titanium construct Sterile R Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·January 16, 2013
NobelReplace Conical Connection (CC) PMC RP 4.3x10mm, REF: 37291 - Product Usage: implants are intended to be used in the upper or lower jaw bone (osseointegration) and used for anchoring or supporting tooth replacements to restore chewing function.
FDA Enforcement
Class II
·Terminated·NOBEL BIOCARE SERVICES AG·August 26, 2020
Philips Respironics V60 Ventilator Part Number 1053615 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
FDA Enforcement
Class II
·Terminated·Respironics California, LLC·February 3, 2021
BioGX SARS-CoV-2 Reagents for BD MAX System Catalog number (REF) 444213. In vitro diagnostic. SARS-CoV-2 Reagents is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal, nasal, mid-turbinate, and oropharyngeal swab specimens, nasopharyngeal wash/aspirate or nasal aspirates obtained from individuals suspected of COVID-19 by their healthcare provider.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·February 17, 2021
Endoscopic Cleaning Brush, single use, sold in kits and labeled as the following: a. Item Number DYK1002DCB, BRUSH, CLEANING, DOUBLE ENDED, W/ HANDLE - 300 EA/CS, 50EA/BX, 6BX/CS; b. Item Number DYK1002DBDE, BRUSH, CLEANING, DBL, DIF ENDS - 500 EA/CS, 50 EA/BX, 10 BX/CS; c. Item Number DYK1002DBSE, BRUSH, CLEANING, DBL, SAME END - 500 EA/CS, 50 EA/BX, 10 BX/CS; d. Item Number DYK1002SBC, BRUSH, CLEANING, SINGLE END - 500 EA/CS, 50 EA/BX, 10 BX/CS
FDA Recall
Terminated
·Medline Industries Inc·Product code MNL·June 15, 2018
Ki Mobility, Little Wave Tyke (Weight Limit: 95 lbs), Specifically the IFU The Little Wave Tyke is a manually operated device that can be used for medical purposes and is used to assist a disabled person to move from one place to another while sitting. Intended to be used by persons up to 95 pounds for transport.
FDA Recall
Terminated
·Ki Mobility Llc·Product code INM·November 19, 2021