14 results · 33ms · Sources: EU EUDAMED, US FDA

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Bernafon

FDA UDI
Bernafon AG·05711584078679·AQ CO9 MNR T, 2.4G NFM DPB MAC ACCUQ

Ceramco® II Silver™

FDA UDI
Dentsply International Inc.·D0011821410·

Novo Surgical Inc.

FDA UDI
NOVO SURGICAL, INC.·00842331192548·brown tissue forceps, 8x8 teeth, 12" (30.5 cm)

SMARTEPIL,DEPILASE YAG LASE PLUS

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

ARCHITECT C-PEPTIDE CALIBRATORS, AND ARCHITECT C-PEPTIDE CONTROLS, MODELS 3L53-01, 3L53-10

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED)

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

POLARIS

FDA Adverse Event
Malfunction ·SOPHYSA·Product code JXG·May 31, 2023

PRIMEADVANCED

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·February 27, 2013

TRUEMETRIX

FDA Adverse Event
Malfunction ·TRIVIDIA HEALTH, INC.·Product code NBW·February 24, 2017

DELTA SHUNT KIT, REGULAR, PERFORMANCE LEVEL 1

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·October 17, 2014

EON MINI

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 14, 2013

TRANSTAR STRETCHER

FDA Adverse Event
Malfunction ·HILL-ROM, INC.·Product code FPO·June 23, 2011

RESTORE ADVANCED

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·February 11, 2015

Zenith Alpha Abdominal Endovascular Graft - Distributed OUS only. Indicated for the endovascular treatment of patients with abdominal aortic or aorto-iliac aneurysms Reference Part Number (RPN): ZIMB-22-108 ZIMB-22-118 ZIMB-22-128 ZIMB-22-70 ZIMB-22-84 ZIMB-22-98 ZIMB-24-108 ZIMB-24-118 ZIMB-24-128 ZIMB-24-70 ZIMB-24-84 ZIMB-24-98 ZIMB-26-108 ZIMB-26-118 ZIMB-26-128 ZIMB-26-70 ZIMB-26-84 ZIMB-26-98 ZIMB-28-108 ZIMB-28-118 ZIMB-28-128 ZIMB-28-70 ZIMB-28-84 ZIMB-28-98 ZIMB-30-108 ZIMB-30-118 ZIMB-30-128 ZIMB-30-70 ZIMB-30-84 ZIMB-30-98 ZIMB-32-108 ZIMB-32-108 ZIMB-32-118 ZIMB-32-128 ZIMB-32-70 ZIMB-32-84 ZIMB-32-98 ZIMB-36-108 ZIMB-36-118 ZIMB-36-128 ZIMB-36-84 ZIMB-36-98

FDA Enforcement
Class II ·Terminated·Cook Inc.·September 23, 2020