11 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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G-CEM ONE
FDA 510(k)
FDA Class 2
·Dental
N/A
FDA UDI
STRYKER SUSTAINABILITY SOLUTIONS, INC.·00885825003791·Steerable Diagnostic EP Catheter , LARGE 4.0, 8...
BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code FMI·October 31, 2019
HEMOCHRON JR. SIGNATURE +
FDA 510(k)
FDA Class 2
·Hematology
TALON BALLOON DILATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·May 15, 2025
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·October 24, 2014
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·July 29, 2011
STANDARD BARREL HIP PLATE, KEYLESS OMEGA 3 135°, 4 HOLES
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS-SELZACH·Product code KTT·July 2, 2013
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC·Product code NIQ·January 12, 2007
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