37 results · 26ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

Spectrum IQ Infusion System with Dose IQ Safety Software

FDA 510(k)
FDA Class 2 ·General Hospital

Intrigue

FDA UDI
LANCER ORTHODONTICS, INC.·00817573020102·INTRG WHISP-Z ROTH ANT 0T 0A 018 LO

SHEATHES STERILE ULTRASOUND GEL

FDA 510(k)
FDA Class 2 ·Radiology

FlexPointer 1.5 Single Use, FlexTube 3 Single Use

FDA 510(k)
FDA Class 2 ·Neurology

IMP, TSV, 4.1, 1, MTX,MC,

FDA Adverse Event
Malfunction ·ZIMMER DENTAL·Product code DZE·February 24, 2022

SMS STEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·November 4, 2025

SMS STEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·January 8, 2026

SMS STEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·January 29, 2026

MPACT ACETABULAR SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·January 23, 2026

HEARTSTRING III PROXIMAL SEAL SYSTEM

FDA Adverse Event
Injury ·GUIDANT CARDIAC SURGERY·Product code DXC·November 12, 2008

ACCESS

FDA Adverse Event
Malfunction ·BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS·Product code FPA·August 31, 2011

INTERSTIM II

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·July 16, 2013

MECTACER BIOLOX DELTA FEMORAL BALL HEAD

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·November 13, 2024

MECTACER BIOLOX DELTA FEMORAL BALL HEAD

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·August 13, 2025

MPACT ACETABULAR SYSTEM IMPLANTS

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code LPH·November 5, 2025

MPACT ACETABULAR SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·December 18, 2025

BALL HEADS: MECTACER 01.29.211 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE XL

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·May 26, 2023

bk3500 Ultrasound System w/battery; Model No. 2300-41; System, Imaging, Pulsed Doppler, Ultrasonic

FDA Recall
Open, Classified ·B-K Medical A/S Mileparken 34 Herlev Denmark·Product code IYN·October 9, 2025

SMS STEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·November 18, 2025

MECTACER BIOLOX DELTA FEMORAL BALL HEAD

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·August 27, 2025