22 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
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