3 results
·
10ms
·
Sources: EU EUDAMED, US FDA
Sorin Group Smart Perfusion Pack E-Pack, REF 088511400, Rev: L, Single Use, Sterile, Rx. The firm name on the label is Sorin Group USA, Inc., Arvada, CO.
FDA Enforcement
Class III
·Terminated·LivaNova USA·February 28, 2018
Portex Pulsator Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4080P-2, Sterile, RX. The firm name on the label is Smiths Medical ASD, Inc., Keene, NH.
FDA Enforcement
Class III
·Terminated·Smiths Medical ASD Inc.·September 26, 2018
Wallace Artificial Insemination Catheter, 180 mm, Sterile, Quantity: 1 Box (10 units), Model: AIC18JP, Cooper Surgical Inc., (01) 2 0888937 021749 - Product Usage: Intended use of the product is the introduction of washed spermatozoa into the uterine cavity.
FDA Enforcement
Class III
·Terminated·CooperSurgical, Inc.·April 22, 2020