12 results · 22ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

Enzyme linked immunosorbent assay, for herpes simplex virus, hsv-2

FDA Recall
Terminated ·Siemens Healthcare Diagnostics, Inc·Product code MYF·February 8, 2021

Airway Mobilescope MAF-TM

FDA Recall
Terminated ·Olympus Corporation of the Americas·Product code EOQ·August 8, 2018

Airway Mobilescope MAF-TM

FDA Enforcement
Class II ·Terminated·Olympus Corporation of the Americas·October 10, 2018

Cosmetic color soft contact lenses. Multiple colors which include Blue, Green, Aqua, Brown, Grey. BesCon (brand)

FDA Recall
Terminated ·My Cosmetics Inc·Product code LPL·November 13, 2002

QUADROX-i Neonatal without integrated arterial filter and VHK 11000 (VKMO 10000-USA#QUADROX-i Neo.+Reservoir), Part Number 701055120 The membrane oxygenator QUADROXi Neonatal is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery.

FDA Recall
Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code DTZ·October 25, 2018

QUADROX-i Neonatal with integrated arterial filter and VHK 11000 (VKMO 11000-USA#QUADROX-i Neo.+Reservoir), Part Number 701055207 The membrane oxygenator QUADROXi Neonatal is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery.

FDA Recall
Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code DTZ·October 25, 2018

First Breath Adult Venturi Oxygen Mask with Corrugated Tubing, O2 Diluter Jets (6), Oxygen Tubing, and Nebulizer Hood. (Non-latex) 50/CA Reorder Number: 002610 For acute use, e.g. Post-op recovery, minimal trauma, patient transfer; used for patients requiring more oxygen than is delivered via a standard nasal cannula (>6L/minute). During inspiration, the patient draws gases both from the oxygen flowing into the mask through the tubing as well as the room via ports on the sides of the mask. Oxygen concentration delivered is 40 60% depending on the patients breathing rate and tidal volume

FDA Recall
Terminated ·Smiths Medical Hythe Hythe, Kent United Kingdom·Product code BYF·February 11, 2011

Advanta SuperSoft Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.

FDA Recall
Terminated ·Atrium Medical Corporation·Product code DYF·July 12, 2013

Mask adult, elastic strap style, Percent-O2 Lock air entrainment system, w/7' tube (Linde) - 50/cs; Salter Labs, Arvin, CA 93203 Intended usage: respiratory therapy.

FDA Recall
Terminated ·Salter Laboratories, Division of Regulatory Affairs·Product code BYF·March 25, 2011

Advanta VS Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.

FDA Recall
Terminated ·Atrium Medical Corporation·Product code DYF·July 12, 2013

Value Pack General Anesthesia Kit, (containing Reorder Number: 001421 Oxygen Face Mask) Reorder Number: VP1302 For acute use, e.g. Post-op recovery, minimal trauma, patient transfer; used for patients requiring more oxygen than is delivered via a standard nasal cannula (>6L/minute). During inspiration, the patient draws gases both from the oxygen flowing into the mask through the tubing as well as the room via ports on the sides of the mask. Oxygen concentration delivered is 40 60% depending on the patients breathing rate and tidal volume

FDA Recall
Terminated ·Smiths Medical Hythe Hythe, Kent United Kingdom·Product code BYF·February 11, 2011

Advanta VXT Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.

FDA Recall
Terminated ·Atrium Medical Corporation·Product code DYF·July 12, 2013