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

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ARIA

FDA 510(k)
FDA Class 2 ·Cardiovascular

365 by Whole Foods Market

FDA UDI
CORMAN SPA·00099482522919·365 Organic Cotton Tampons without Applicator -...

Henry Schein

FDA UDI
HENRY SCHEIN, INC.·00304040062470·Endoflex Reamers 21 mm

SOLIDEA

FDA UDI
CALZIFICIO PINELLI SRL·08300496001317·MAGIC 50, SIZE M, NERO, TIGHTS WITH A THREE-DIM...

Fitbone Trochanteric

FDA UDI
ORTHOFIX SRL·18059015376418·FITBONE TROCHANTERIC TRIAL NAIL L317MM D11MM

artVeneer life

FDA UDI
Merz Dental GmbH·D7092001317·artVeneer life lower anteriors, UCL, C1

Rampart One Lumbar Interbody Fusion System

FDA UDI
SPINEOLOGY INC.·M7401001317·Trial 12mm M 12°

Phonak Brand

FDA UDI
Sonova AG·07613389403053·myPhonak 4.0 app

SPECTRA-VRM Q-SWITCHED ND:YAG LASER SYSTEM, SPECTRA-VRM

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

RETRAX RETRACTING NEEDLE SYRINGE, SIZE 3CC

FDA 510(k)
FDA Class 2 ·General Hospital

UniTip Catheter

FDA UDI
Unisensor AG·07640172971352·

MINIMED QUICK-SET

FDA Adverse Event
Injury ·UNOMEDICAL UM-D·Product code FPA·April 10, 2025

INFUSOR

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code MEB·September 17, 2021

INFUSOR

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code MEB·September 4, 2024

INFUSOR

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·May 14, 2018

HIWIRE HYDROPHILIC WIRE GUIDE

FDA Adverse Event
Injury ·COOK, INC.·Product code DQX·March 5, 2013

OT ULTRALINK METER

FDA Adverse Event
Malfunction ·LIFESCAN INC.·Product code NBW·February 24, 2011

ACCU-CHEK SPIRIT

FDA Adverse Event
Malfunction ·DISETRONIC MEDICAL SYSTEMS·Product code LZG·February 19, 2008

SENSAR IOL

FDA Adverse Event
Malfunction ·AMO PUERTO RICO MFG. INC.·Product code HQL·May 7, 2024

Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

FDA Enforcement
Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013