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

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ERISE Laser handpiece

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

Ophthalmic Knife

FDA UDI
KATENA PRODUCTS, INC.·00841668113257·VITRECTOMY KNIFE 25GA (BX/5)

Corneal Trephine

FDA UDI
KATENA PRODUCTS, INC.·00841668112939·CORNEAL TREPHINE BLADE8.0MM

Corneal Trephine

FDA UDI
KATENA PRODUCTS, INC.·00841668112519·BARRON VACUUM TREPHINE 8.0MM

B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. DENTAL IMPLANT SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

ULTRAGUIDE CT-GUIDE 1010

FDA 510(k)
FDA Class 2 ·Radiology

EDWARDS ESHEATH+ INTRODUCER SET

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES·Product code DYB·April 28, 2022

UNKNOWN EDWARDS TRANSFEMORAL SHEATH

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code DYB·March 12, 2026

TF SHEATH UNKNOWN

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES·Product code DYB·July 18, 2023

UNKNOWN EDWARDS LIFESCIENCES SHEATH

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code DYB·May 12, 2025

EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES LLC·Product code NPT·December 5, 2024

TENDRIL SDX

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, INC., CARDIAC RHYTHM MANAGEMENT DIVISI·Product code NVN·January 13, 2014

PLV-100

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code CBK·June 28, 2013

HS III PROXIMAL SEAL SYSTEM 4.3MM

FDA Adverse Event
Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code DXC·August 5, 2011

ESHEATH INTRODUCER SHEATH

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code DYB·December 17, 2021

UNKNOWN EDWARDS LIFESCIENCES SHEATH

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code DYB·May 30, 2024

UNKNOWN EDWARDS INTRODUCER SHEATH SET

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code NPT·June 21, 2023

EDWARDS TRANSFEMORAL SHEATH

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code NPT·January 20, 2022

ATTUNE PS FEM LT SZ 8 CEM

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code JWH·November 13, 2025

FLEXCATH ADVANCE STEERABLE SHEATH

FDA Adverse Event
Injury ·MEDTRONIC CRYOCATH LP·Product code DRA·March 23, 2023