10 results
·
26ms
·
Sources: EU EUDAMED, US FDA
ANALGESIA BREATHING CIRCUIT
FDA 510(k)
FDA Class 1
·Anesthesiology
PressON™
FDA UDI
NEXUS SPINE, L.L.C.·B6788203520·Retractor Foot
SURGICAL DYNAMICS OGDEN SUTURE ANCHOR WITH SUTURE
FDA 510(k)
FDA Class 2
·Orthopedic
STRYKER QUIKFLAP STERILE PROCEDURE PACK
FDA 510(k)
FDA Class 2
·Neurology
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 9, 2014
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 31, 2012
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code MDS·August 30, 2010
3M Steri-Vac Gas Sterilizer/Aerator, models 5XL and 8XL.
FDA Enforcement
Class II
·Terminated·3M Company - Health Care Business·May 4, 2016
Presource PBDS, Kit, Common. Kit includes a exerciser volumetric 5000 ML device, two items of cloth, skin prep 2% CHG, a packet of 4 chlorhexidine gluconate antiseptic cloths, and Gatorade pouches. Product Usage: The kit is provided to a patient pre-surgery, as part of the Enhanced Recovery After Surgery protocol. Items included at 1) an exerciser volumetric 5000ML device that is utilized to foster improved lung performance in an effort to avoid potential pulmonary post-operative complications, 2) up to two items of cloth, skin prep 2% CHG, a packet of for chlorhexidine gluconate antiseptic cloths utilized by the patient to reduce the risk of surgical site infections by wiping the body in a prescribed manner, 3) up to two Gatorade to help restore the body s electrolytes when fasting prior to surgery.
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·July 25, 2018
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021