13 results
·
58ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
Burn Relief¿, MODEL #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200, CATALOG #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200 --- DRESSING,WOUND,HYDROGEL W/OUT DRUG AND/OR BIOLOGIC. --- Burn Relief¿ products are self-cooling, non-adhering and are intended to be used on 1st and 2nd degree burns.
FDA Enforcement
Class II
·Terminated·O-Two Medical Technologies, Inc.·July 19, 2017
O-Two Equinox Relieve N2O/O2 Analgesic Gas Mixing and Delivery System Model#: 01EQ1000
FDA Recall
Terminated
·O-Two Medical Technologies, Inc.·Product code BZR·May 14, 2018
Burn Relief, MODEL #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200, CATALOG #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200 --- DRESSING,WOUND,HYDROGEL W/OUT DRUG AND/OR BIOLOGIC. --- Burn Relief products are self-cooling, non-adhering and are intended to be used on 1st and 2nd degree burns.
FDA Recall
Terminated
·O-Two Medical Technologies, Inc.·Product code NAE·September 30, 2015
O-Two Adult Ventilation Timer, MODEL #(s): 01BM1000-CS, 01BM3201-MOTP-CS, 01BM3201-MOTL-CS, CATALOG #(s): 01BM1000 --- INTENDED USE: The Adult Ventilation Timer is intended to guide the rescuer to provide ventilations at a rate appropriate for adult patients
FDA Recall
Terminated
·O-Two Medical Technologies, Inc.·Product code JBS·June 23, 2015
O-Two Adult Ventilation Timer, MODEL #(s): 01BM1000-CS, 01BM3201-MOTP-CS, 01BM3201-MOTL-CS, CATALOG #(s): 01BM1000 --- INTENDED USE: The Adult Ventilation Timer is intended to guide the rescuer to provide ventilations at a rate appropriate for adult patients
FDA Enforcement
Class II
·Terminated·O-Two Medical Technologies, Inc.·July 19, 2017
O-Two Equinox¿ Relieve N2O/O2 Analgesic Gas Mixing and Delivery System Model#: 01EQ1000
FDA Enforcement
Class II
·Terminated·O-Two Medical Technologies, Inc.·August 29, 2018
e600 Automatic Transport Ventilator, Model Number 01EVE600
FDA Enforcement
Class I
·Terminated·O-Two Medical Technologies, Inc.·April 10, 2019
e500 Automatic Transport Ventilator, Model Number 01EVE500
FDA Enforcement
Class I
·Terminated·O-Two Medical Technologies, Inc.·April 10, 2019
e700 Automatic Transport Ventilator, Model Number 01EVE700
FDA Enforcement
Class I
·Terminated·O-Two Medical Technologies, Inc.·April 10, 2019
e600 Automatic Transport Ventilator, Model Number 01EVE600
FDA Recall
Terminated
·O-Two Medical Technologies, Inc. 45A Armthorpe Road Brampton Canada Ontario·Product code BTL·February 12, 2019
e500 Automatic Transport Ventilator, Model Number 01EVE500
FDA Recall
Terminated
·O-Two Medical Technologies, Inc. 45A Armthorpe Road Brampton Canada Ontario·Product code BTL·February 12, 2019
e700 Automatic Transport Ventilator, Model Number 01EVE700
FDA Recall
Terminated
·O-Two Medical Technologies, Inc. 45A Armthorpe Road Brampton Canada Ontario·Product code BTL·February 12, 2019
Olympus Fluid Aspiration Set; a sterile set of silicone tubing and connectors for use with the Olympus SP-2 Fluid Irrigation & Aspiration Pump; 10 sets per box; Manufactured for: Olympus America Inc., Two Corporate Center Drive, Melville, NY 11747-3157; catalog #72-00114-0 The fluid aspiration set is used in conjunction with the Olympus SP-2 pump for fluid aspiration during urological endoscopic procedures or laparoscopic procedures.
FDA Recall
Terminated
·Northgate Technologies, Inc.·Product code KQT·July 25, 2011