18 results · 24ms · Sources: EU EUDAMED, US FDA

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BRACCO INJEENERING TRANSFER SET

FDA 510(k)
FDA Class 2 ·General Hospital

CLEARTOOTH DIGITAL X-RAY SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

SYRINGE 3ML LL EURO 200 S/C

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·July 6, 2021

ALINITY C PROCESSING MODULE

FDA Adverse Event
Malfunction ·ABBOTT LABORATORIES·Product code JJE·August 21, 2023

ALINITY C PROCESSING MODULE

FDA Adverse Event
Malfunction ·ABBOTT LABORATORIES·Product code JJE·January 11, 2024

ARCHITECT C8000

FDA Adverse Event
Malfunction ·ABBOTT LABORATORIES·Product code JJE·December 11, 2020

OT VERIO2 METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 23, 2016

HOMECHOICE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·October 1, 2014

PINNACLE MTL INS NEUT36IDX50OD

FDA Adverse Event
Injury ·DEPUY INTL., LTD - 8010379·Product code KWA·May 29, 2013

RESTORE RECHARGABLE NEUROSTIMULATOR

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·August 22, 2008

BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC)

FDA Adverse Event
Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·September 29, 2022

BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC)

FDA Adverse Event
Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·October 11, 2022

BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC)

FDA Adverse Event
Injury ·BECTON DICKINSON CARIBE LTD.·Product code MDB·October 10, 2022

BD PLASTIPAK¿ LUER-LOK¿ TIP SYRINGE

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·February 9, 2022

BD SYRINGE 3ML LL

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·January 13, 2021

AQUAPAK 340 SW, 340 ML W/404 ADAPTOR. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.

FDA Enforcement
Class II ·Terminated·Teleflex Medical·February 18, 2015

Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

FDA Enforcement
Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015