78 results
·
22ms
·
Sources: EU EUDAMED, US FDA
TigerConnect Alarm Management
FDA 510(k)
FDA Class 2
·Cardiovascular
Integra® Miltex®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780160441·Integra® Miltex® Cooley Vascular Clamp, 5-1/2",...
Stage 1
FDA UDI
KEYSTONE DENTAL, INC.·D768S2432701K0·COC Abutment
SIRUS INTRAMEDULLARY NAIL-FEMORAL AND TIBIAL NAILS, MODELS 02.02631, 02.02651, 02.02652 SERIES
FDA 510(k)
FDA Class 2
·Orthopedic
Optima XR646
FDA 510(k)
FDA Class 2
·Radiology
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·September 24, 2021
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·November 11, 2014
PERFORMANCE PRO AMBULANCE COT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·September 1, 2011
FEMALE NON-VENTED LUER LOCK COVER
FDA Adverse Event
Other
·ICU MEDICAL, INC.·Product code FPA·July 12, 2013
BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·December 8, 2025
BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code FMI·October 15, 2025
BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code FMI·December 3, 2025
BD VACUTAINER® SERUM
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·January 26, 2026
BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code FMI·November 17, 2025
BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code FMI·November 20, 2025
BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·December 8, 2025
BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·December 8, 2025
BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code FMI·December 8, 2025
BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·September 29, 2025
PKG, GRASPER FORCEPS, SERRSTED FENESTRATED, P/N 0250080318. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014