1,688 results · 23ms · Sources: EU EUDAMED, US FDA

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syngo Application Software

FDA 510(k)
FDA Class 2 ·Radiology

K-Systems

FDA UDI
Coopersurgical, Inc.·00888937025064·T45 Warming Plate

Kubtec Mozart Supra (XPERT 84) Radiography System

FDA 510(k)
FDA Class 2 ·Radiology

Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch

FDA 510(k)
FDA Class 2 ·Cardiovascular

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 6, 2014

COLLEAGUE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 1, 2011

MATNEU SCR Ø1.5 SELF-DRILL L5 TAN 1U I/C

FDA Adverse Event
Malfunction ·SYNTHES MONUMENT·Product code JEY·July 17, 2013

Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23055 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: No

FDA Enforcement
Class II ·Ongoing·CooperSurgical, Inc.·December 25, 2024

BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·May 8, 2026

BD VACUTAINER® SST¿

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·January 8, 2026

BD VACUTAINER® SST¿

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·December 30, 2025

BD VACUTAINER® SST¿

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code JKA·October 15, 2025

BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·February 19, 2026

BD VACUTAINER® SST¿

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·May 20, 2026

BD VACUTAINER® SST¿

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·May 20, 2026

BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·May 27, 2026

BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·May 26, 2026

BD VACUTAINER® SST¿

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·May 20, 2026

BD VACUTAINER® SST¿

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·May 20, 2026

BD VACUTAINER® SST¿

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·May 20, 2026