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

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REPROCESSED ELECTROSURGICAL INSTRUMENT

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

Leva® Anterior Interbody System

FDA UDI
Spine Wave, Inc.·10840642109016·Modular Spacer, 38 mm (W) x 30 mm (L) x 21 mm (...

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450387245·

BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·December 10, 2024

BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·December 29, 2024

BD LUER-LOK

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·December 29, 2024

VORTEX ACCESS SYSTEM

FDA 510(k)
FDA Class 2 ·General Hospital

REAVILLMED PRESSURE MONITORING SYSTEM AND PICC

FDA 510(k)
FDA Class 2 ·Cardiovascular

BD LUER-LOK

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·January 13, 2025

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 13, 2013

ZIMMER AIR DERMATOME II HANDPIECE

FDA Adverse Event
Malfunction ·ZIMMER SURGICAL·Product code GFD·September 11, 2014

M2A 38MM FLARED ONE PIECE CUP 38MM ID X 56MM OD

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code KWA·June 1, 2011

BD DISCARDIT¿ II SYRINGE

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·May 23, 2023

EVOLUT FX PLUS VALVE

FDA Adverse Event
Injury ·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·August 27, 2025

BD DISCARDIT¿ II SYRINGE

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·May 23, 2023

BD LUER-LOK

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·December 21, 2024

BD LUER-LOK

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·December 21, 2024

Achieva 1.5T Conversion

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·November 29, 2023

EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG-36UX Ultrasound Fiber Gastroscope Used to provide optical and sonographic visualization of and therapeutic access to the Upper Gastrointestinal Tract.

FDA Enforcement
Class II ·Terminated·Pentax Medical Company·July 30, 2014

Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System.

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·January 24, 2024