18 results · 21ms · Sources: EU EUDAMED, US FDA

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SPY-PHI System with SPY-PHI Fluorescence Assessment Software

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04049772777617·LUMBAMED BASIC DORSAL STAY WM SILVER IV

Ophthalmic Knife

FDA UDI
KATENA PRODUCTS, INC.·00841668113226·VITRECTOMY KNIFE 20GA (BX/5)

Ophthalmic Knife

FDA UDI
KATENA PRODUCTS, INC.·00841668113264·SIDEPORT KNIFE 1MM ANGLED (BX/5)

Ophthalmic Knife

FDA UDI
KATENA PRODUCTS, INC.·00841668113356·CLEAR CORNEA KNIFE 2.8MM (BX/5)

NOBELACTIVE TIULTRA NP 3.5X13MM

FDA Adverse Event
Injury ·NOBEL BIOCARE AB·Product code DZE·May 31, 2021

NOBELACTIVE TIULTRA NP 3.5X13MM

FDA Adverse Event
Injury ·NOBEL BIOCARE AB·Product code DZE·May 31, 2021

RELIANCE ENDOSCOPE PROCESSING SYSTEM

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

G-1 VERSION 3, MODEL 10048

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

Y-90 THERASPHERE

FDA Adverse Event
Injury ·BIOCOMPATIBLES UK LIMITED·Product code NAW·December 16, 2022

EXPRESS2 MONORAIL CORONARY STENT DELIVERY SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC·Product code MAF·October 19, 2006

UNKNOWN DEPUY PFC CURVED 3X8 TIBIAL INSERT

FDA Adverse Event
Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code JWH·October 27, 2014

HEARTSTART ONSITE

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 28, 2013

CAPSUREFIX NOVUS

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011

ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

FDA Adverse Event
Injury ·ETHICON INC.·Product code GAT·July 15, 2025

SPECTRA OPTIA

FDA Adverse Event
Malfunction ·TERUMO BCT·Product code GKT·December 22, 2022

ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FCG·October 25, 2022

ATAR Disposable Extension Cable, sold under brand names: ATAR Disposable Series, ATAR 53912 Disposable Series, and XI Disposable Series. Model codes: ATAR D-A DARK BLUE DISPOSABLE, ATAR D-V WHITE DISPOSABLE, ATAR D-MDT DISPOSABLE, ATAR D-T DISPOSABLE, ATAR D-R DISPOSABLE, ATAR D-RL DISPOSABLE, ATAR D-MDTL DISPOSABLE, ATAR D-MDTS, ATAR D-R1 DISPOSABLE, ATAR D-R NP DISPOSABLE, ATAR D-MDT2, ATAR D-MDTR, ATAR D-R D2P, ATAR D-R T4P, ATAR D-R X2, ATAR D-V2, ATAR D-IS1-2PACE, PACE 101H, PACE 203H WITH ATAR D-MDTS, PACE 203H, PACE 101H WITH ATAR D-T, PACE 300, XI.D-A, DARK BLUE, DISPOSABLE, XI.D-V WHITE DISPOSABLE, XI.D-MDT DISPOSABLE 30 CM, XI.D-T DISPOSABLE, XI.D-RL, XI.D-R DISPOSABLE, 53912D - MDTS ATAR DISPOSABLE Cable is intended to connect an electrode/lead from a patients or another cable to a diagnostic machine or an external pacemaker

FDA Enforcement
Class I ·Terminated·Oscor, Inc.·July 19, 2017