17 results
·
6ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
×
Safil QUI + UNDY 5/0 (1) 45CM DSMP13 Suture
FDA Enforcement
Class II
·Terminated·Aesculap Implant Systems LLC·November 2, 2016
Physio-Control QuikCombo Pacing/Defibrillation/ECG Electrodes RediPak¿ Preconnect System Item Code:PM20022
FDA Enforcement
Class II
·Terminated·Covidien LLC·September 9, 2015
Sevoflurane E_Vap.(Quik-Fil):used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concentration to an A9 anesthesia system. Part Number 115-066755-00
FDA Enforcement
Class II
·Ongoing·Mindray DS USA, Inc. dba Mindray North America·September 11, 2024
MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Physio-Control¿ Quik-Combo" Connector, REF/Catalog Number 2602M Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602 electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (non-invasive) cardiac pacemaker and the pediatric patients skin. The electrode is intended for use on pediatric infants whose weight is less than 10 kg. (22 lbs.).
FDA Enforcement
Class II
·Terminated·ConMed Corporation·April 4, 2018
HipLOC Hip Fracture Fixation System-Hiploc System 140¿ Plate 38 mm Barrel 4 Hole Plate Item Number: 2110-140-004 Product Usage: The HipLOC Compression Hip Screw may be used primarily for fixation of bone fractures. Specific indications include open reduction and internal fixation of a wide variety of fractures of the proximal femur: intracapsular fractures, intertrochanteric fractures and subtrochanteric fractures
FDA Enforcement
Class II
·Terminated·Biomet UK Ltd.·October 3, 2018
HipLOC Hip Fracture Fixation System-Hiploc System 135¿ Plate 38 mm Barrel 4 Hole Plate Item Number: 2110-135-004 Product Usage: The HipLOC Compression Hip Screw may be used primarily for fixation of bone fractures. Specific indications include open reduction and internal fixation of a wide variety of fractures of the proximal femur: intracapsular fractures, intertrochanteric fractures and subtrochanteric fractures
FDA Enforcement
Class II
·Terminated·Biomet UK Ltd.·October 3, 2018
HipLOC Hip Fracture Fixation System- Hiploc System 130¿ Plate 38 mm Barrel 4 Hole Plate Item Number: 2110-130-004 Product Usage: The HipLOC Compression Hip Screw may be used primarily for fixation of bone fractures. Specific indications include open reduction and internal fixation of a wide variety of fractures of the proximal femur: intracapsular fractures, intertrochanteric fractures and subtrochanteric fractures
FDA Enforcement
Class II
·Terminated·Biomet UK Ltd.·October 3, 2018
HipLOC Hip Fracture Fixation System-Hiploc System 135¿ Plate 38 mm Barrel 3 Hole Plate Item Number: 2110-135-003 Product Usage: The HipLOC Compression Hip Screw may be used primarily for fixation of bone fractures. Specific indications include open reduction and internal fixation of a wide variety of fractures of the proximal femur: intracapsular fractures, intertrochanteric fractures and subtrochanteric fractures
FDA Enforcement
Class II
·Terminated·Biomet UK Ltd.·October 3, 2018
Medicina Oral Tip Syringe 2.5ml Code: OT25
FDA Enforcement
Class II
·Ongoing·Medicina Uk Ltd·October 26, 2022
Medicina Oral Tip Syringe 1ml Code: OT01
FDA Enforcement
Class II
·Ongoing·Medicina Uk Ltd·October 26, 2022
Medicina ENFit 1ml Reusable Low Dose Enteral Syringe Code: LHE01LD
FDA Enforcement
Class II
·Ongoing·Medicina Uk Ltd·October 26, 2022
Medicina Oral Tip Syringe 0.5ml Code: OT005
FDA Enforcement
Class II
·Ongoing·Medicina Uk Ltd·October 26, 2022
Medicina Reusable Oral syringe 5ml Code: OTH05
FDA Enforcement
Class II
·Ongoing·Medicina Uk Ltd·October 26, 2022
Medicina Reusable Oral syringe 2.5ml Code: OTH25
FDA Enforcement
Class II
·Ongoing·Medicina Uk Ltd·October 26, 2022
Medicina Reusable Oral syringe 1ml Code: OTH01
FDA Enforcement
Class II
·Ongoing·Medicina Uk Ltd·October 26, 2022
Medicina ENFit 5ml Reusable Enteral Syringe Code: LHE05
FDA Enforcement
Class II
·Ongoing·Medicina Uk Ltd·October 26, 2022
GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system
FDA Enforcement
Class II
·Ongoing·GE Healthcare GmbH·December 24, 2025