18 results · 32ms · Sources: EU EUDAMED, US FDA

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V20 system

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Paxeon Femoral Head

FDA UDI
PAXEON RECONSTRUCTION LLC·08177570200115·Paxeon Head, Ceramic Size 28mm S

Signature Femoral Head

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215001896·

OrthoMedFlex

FDA UDI
ORTHOMEDFLEX LLC·M7161111526110·Ceramic Femoral Head, 28mm, S (-3.5 mm)

ECP HEALTH SYSTEM, MODEL 2005

FDA 510(k)
FDA Class 2 ·Cardiovascular

POWDER-FREE VINYL PATIENT EXAMINATION GLOVES

FDA 510(k)
FDA Class 1 ·General Hospital

SIGNATURE Head - BIOLOX Delta

FDA UDI
AMPLITUDE SAS·03701089520720·

DYNASTY® A-CLASS® STD POLY LINER 28MM GROUP B

FDA Adverse Event
Injury ·MICROPORT ORTHOPEDICS INC.·Product code JDI·April 7, 2025

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·June 13, 2025

I-STAT 6+ CARTRIDGE

FDA Adverse Event
Malfunction ·ABBOTT POINT OF CARE·Product code JGS·October 9, 2017

VIRTUOSO DR

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·June 7, 2013

9600

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 27, 2011

AXSYM RUBELLA IGG ANTIBODY

FDA Adverse Event
Malfunction ·ABBOTT LABORATORIES·Product code LFX·September 10, 2008

BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code NGT·January 6, 2023

Gold-Tite Square Uniscrew Item: UNISG Dental implants

FDA Enforcement
Class II ·Terminated·Biomet 3i, LLC·August 24, 2016

BD POSIFLUSH¿ SP SYRINGE

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code NGT·February 24, 2023

Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.

FDA Enforcement
Class II ·Terminated·Elekta, Inc.·April 9, 2014

ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

FDA Enforcement
Class II ·Ongoing·Elekta, Inc.·December 13, 2023