1,691 results
·
31ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
SwiftMR
FDA 510(k)
FDA Class 2
·Radiology
K-Systems
FDA UDI
Coopersurgical, Inc.·00888937025071·T47 Warming Plate
N/A
FDA UDI
inomed Medizintechnik GmbH·EINO2308549·DBS Guide tube, 10 mm to target, for DBS electr...
DePuy PINNACLE Dual Mobility Liner
FDA 510(k)
FDA Class 2
·Orthopedic
PROTOCO2L COLON INSUFFLATOR WITH PERFORMANCE IMPROVEMENTS, MODEL 6400
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TUBE, GASTROINTESTINAL (AND ACCESS)
FDA Adverse Event
Malfunction
·C. R. BARD INC. (BASD)·Product code KNT·October 28, 2008
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code NIQ·August 26, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 17, 2013
Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23054 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 INSULIN SYRINGE 1CC 31G
FDA Adverse Event
Injury
·BD MEDICAL - DIABETES CARE·Product code FMF·September 30, 2015
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