78 results · 22ms · Sources: EU EUDAMED, US FDA

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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