12 results
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20ms
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Sources: EU EUDAMED, US FDA
Bendit2.7 Steerable Microcatheter
FDA 510(k)
FDA Class 2
·Cardiovascular
N/A
FDA UDI
STRYKER SUSTAINABILITY SOLUTIONS, INC.·00885825003357·Diagnostic EP Catheter, Cournand curve, 4 elect...
ELMED
FDA UDI
ELMED INCORPORATED·00842180110212·MONOPOLAR RF-CABLE WITH 4MM EXTRA LONG UNIT PLU...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694016162·Trocar, Short Pointed
FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, CAT NO 11001
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BD Univia RightFit Enteral Extension Sets and Transitional Adapters
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC·Product code NBW·December 27, 2016
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 24, 2014
CONCERTO CRT-D DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·August 11, 2011
RESERVOIR 1.8ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·July 1, 2013
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
Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.
FDA Enforcement
Class II
·Terminated·Bayer Corp·June 11, 2014