10,000 results
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11ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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G-4 HighMag Flange, Model #VG4HM. Standard Gonio Lens for High Magnification Static and Dynamic Gonioscopy.
FDA Recall
Terminated
·Volk Optical Inc·Product code HKS·June 30, 2008
Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-S and H1-S-INT, Small Vessel, 6F (2.2 mm) Recommended sheath, 0.014" (0.36 mm) Compatible guidewire. The HawkOne directional atherectomy system is intended for use in atherectomy of the peripheral vasculature. The HawkOne catheter is indicated for use in conjunction with the SpiderFX embolic protection device in the treatment of severely calcified lesions. The HawkOne catheter is not intended for use in the coronary, carotid, iliac, or renal vasculature.
FDA Enforcement
Class I
·Terminated·ev3 Inc.·January 26, 2022
HSG Trays/HS 5F Catheter Combo; HSG Procedure Tray+ Shapeable 5F HSG catheter. For hysterosonography and hysterosalpingography, gynecological use.
FDA Recall
Terminated
·Catheter Research, Inc·Product code HGS·April 7, 2015
Contact Nipple Shield (Sterile) - 24mm (Standard); Individually wrapped silicone contact nipple shields for immediate use for latch-on difficulties while breastfeeding the baby under professional care only; Manufactured for Medela, Inc., P.O. Box 660, McHenry, IL 60051-0660, Made in Switzerland; article #67203S Individually wrapped for immediate use. For latch-on difficulties. Made of silicone. For use under professional care only while breastfeeding the baby.
FDA Recall
Terminated
·Medela Inc·Product code HFS·May 18, 2011
Gold Hub Finesse Cannula, Catalog Nos. HK10F23; HK12F10; HK12F15; HK12F23; HK14F10; HK14F15; HK14F23; HK16F5; HK16F8
FDA Recall
Terminated
·HK Surgical Inc·Product code FIE·December 3, 2004
Gold Hub Monty Infiltration Cannula, Catalog Nos. IC14HM20; IC16HM15; IC18HM15; IC14HM20; IC16HM15; IC18HM15.
FDA Recall
Terminated
·HK Surgical Inc·Product code FIE·December 3, 2004
Gold Hub Capistrano Cannula, Catalog Nos. HK10C15; HK10C23;HK12C15;HK12C23: HK14C15; HK14C23; HK16C5; HK16C8; HK16C12; HK16C15; HK18C8; HK18C6
FDA Recall
Terminated
·HK Surgical Inc·Product code FIE·December 3, 2004
Offset Femoral Alignment Guide 4mm x 6¿; Product Code: KS 67024 Product Usage: The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Systems. Product Usage: The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Systems
FDA Enforcement
Class II
·Terminated·Omnilife Science Inc.·September 2, 2015
TriActiv FX Embolic Protection System 7F, Catalog numbers 60040-02 (has 190 cm guidewire) and 60040-03 (has 300 cm guidewire). The devices are comprised of four principal components including the ShieldWire Balloon Guidewire, the Shieldwire Inflator, the FX or LFX Catheter, and the AutoStream Flow Control.
FDA Recall
Terminated
·Kensey Nash Corp·Product code FRO·March 28, 2007
.045 X 6 ST Guide Wire, Part number 45-0029-S, Sterile 10 pack of WS-1106ST and has a 6 inch length and 0.045 inch diameter. .054 X 7 ST Guide Wire, Part number 45-0031-S, Sterile 10 Pack of WS-1407ST and has a 7 inch length and 0.054 inch diameter. These guide wires are an orthopedic manual surgical instrument.
FDA Enforcement
Class II
·Terminated·Acumed LLC·March 22, 2017
Offset Femoral Alignment Guide 4mm x 6; Product Code: KS 67024 Product Usage: The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Systems. Product Usage: The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Systems
FDA Recall
Terminated
·Omnilife Science Inc.·Product code FZX·June 9, 2015
Nucleic Acid test intended for screening for MRSA/SA. Each kit has 20 tubes. in vitro diagnostic.
FDA Enforcement
Class II
·Terminated·Roche Molecular Systems, Inc.·April 4, 2018
Vascular Solutions Twin-Pass .023" Dual Access Catheter, model 5230. Sterilized with Ethylene Oxide. The Twin-Pass dual access catheter is a dual lumen catheter designed for use in the coronary and/or peripheral vasculature. The Twin-Pass catheter (Models 5200 and 5230) consists of an over-the-wire (OTW) lumen that runs the length of the catheter and a rapid exchange (RX) delivery lumen on the distal segment. The Twin-Pass catheter has a working length of 135cm and is compatible with various guidewire diameters. Model 5200 also has hydrophilic coating on the distal 18cm of the catheter. The Twin-Pass catheter has white positioning marks located at 95cm (single mark) and 105cm (double marks) from the distal tip, respectively. The Twin-Pass catheter has a marker band located 1mm from the distal tip. Model 5200 contains a second marker band located 11mm from the distal tip to identify the distal end of the OTW lumen.
FDA Enforcement
Class I
·Terminated·Vascular Solutions, Inc.·October 26, 2016
Vascular Solutions Twin-Pass Dual Access Catheter, models 5200, 5210, and 5230. Sterilized with Ethylene Oxide. The Twin-Pass dual access catheter is a dual lumen catheter designed for use in the coronary and/or peripheral vasculature. The Twin-Pass catheter (Models 5200 and 5230) consists of an over-the-wire (OTW) lumen that runs the length of the catheter and a rapid exchange (RX) delivery lumen on the distal segment. The Twin-Pass catheter has a working length of 135cm and is compatible with various guidewire diameters. Model 5200 also has hydrophilic coating on the distal 18cm of the catheter. The Twin-Pass catheter has white positioning marks located at 95cm (single mark) and 105cm (double marks) from the distal tip, respectively. The Twin-Pass catheter has a marker band located 1mm from the distal tip. Model 5200 contains a second marker band located 11mm from the distal tip to identify the distal end of the OTW lumen.
FDA Enforcement
Class I
·Terminated·Vascular Solutions, Inc.·October 26, 2016
Vascular Solutions Twin-Pass RX Dual Access Catheter, model 5210. Sterilized with Ethylene Oxide. The Twin-Pass dual access catheter is a dual lumen catheter designed for use in the coronary and/or peripheral vasculature. The Twin-Pass catheter (Models 5200 and 5230) consists of an over-the-wire (OTW) lumen that runs the length of the catheter and a rapid exchange (RX) delivery lumen on the distal segment. The Twin-Pass catheter has a working length of 135cm and is compatible with various guidewire diameters. Model 5200 also has hydrophilic coating on the distal 18cm of the catheter. The Twin-Pass catheter has white positioning marks located at 95cm (single mark) and 105cm (double marks) from the distal tip, respectively. The Twin-Pass catheter has a marker band located 1mm from the distal tip. Model 5200 contains a second marker band located 11mm from the distal tip to identify the distal end of the OTW lumen.
FDA Enforcement
Class I
·Terminated·Vascular Solutions, Inc.·October 26, 2016
50 mm Screw, Item #BG7050 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.
FDA Enforcement
Class II
·Terminated·Spinal Solutions, LLC·June 5, 2013
40 mm Rod, Item #BG1640 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.
FDA Enforcement
Class II
·Terminated·Spinal Solutions, LLC·June 5, 2013
50 mm Rod, Item #BG1650 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.
FDA Enforcement
Class II
·Terminated·Spinal Solutions, LLC·June 5, 2013
Fang Screw 20mm Fang Plate 21mm Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.
FDA Enforcement
Class II
·Terminated·Spinal Solutions, LLC·June 5, 2013
45 mm Screw, Item #BG7045 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.
FDA Enforcement
Class II
·Terminated·Spinal Solutions, LLC·June 5, 2013