6 results
·
7ms
·
Sources: EU EUDAMED, US FDA
MicroAire K-Wires
FDA Enforcement
Class II
·Terminated·MicroAire Surgical Instruments, LLC·March 15, 2017
Screw Removal Case Assembly, Part Number 1985BASE - Product Usage: The Wright Medical hardware removal kit is designed to facilitate removal of both plates and screws used in foot and ankle procedures. Along with a complete range of drivers, the kit also features driver handles and a range of k-wires to assist in removal of cannulated screws. This product is a multiple use, non-sterile instrument.
FDA Enforcement
Class II
·Terminated·Wright Medical Technology, Inc.·August 19, 2020
Hardware removal kit, Part Number 1985KIT1 - Product Usage: The Wright Medical hardware removal kit is designed to facilitate removal of both plates and screws used in foot and ankle procedures. Along with a complete range of drivers, the kit also features driver handles and a range of k-wires to assist in removal of cannulated screws. This product is a multiple use, non-sterile instrument.
FDA Enforcement
Class II
·Terminated·Wright Medical Technology, Inc.·August 19, 2020
15 g R.K. Epidural Needle (TW), Catalog #/REF #100-1415 Intended for the epidural placement, directly or through an epidural catheter, of anesthetic agents to elicit regional anesthesia
FDA Enforcement
Class II
·Terminated·Epimed International, Inc.·November 9, 2016
King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents.
FDA Enforcement
Class II
·Terminated·King Systems Corp.·October 9, 2013
Code Alert Advanced 4-Way Care Solution, CA520 System, PN 9600-1600, RF Technologies. This product is used to alert caregivers when a patient at risk for falls is leaving a bed or chair.
FDA Enforcement
Class II
·Terminated·RF Technologies, Inc.·July 3, 2013