11 results · 22ms · Sources: EU EUDAMED, 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