24 results · 20ms · Sources: EU EUDAMED, US FDA

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HOMMED OBSERVER, MODEL I

FDA 510(k)
FDA Class 2 ·Cardiovascular

EndoGator Hybrid

FDA UDI
MEDIVATORS INC.·00724995224219·EndoGator Tubing Hybrid, Fuji 700 is used with ...

Ophthalmic Cannula

FDA UDI
KATENA PRODUCTS, INC.·00841668114087·SIMCOE CORTEX EXTRACTOR (PK/10)

SCANLAN® Needle Holders

FDA UDI
SCANLAN INTERNATIONAL INC·00846159002843·Jacobson Micro Needle Holder Round Handle

TEMPORARY PACEMAKER EXTENSION CABLE, MODELS 5235, 5235A, 5235V, TEMPORARY PACEMAKER SURGICAL EXTENSION CABLE, MODELS 528

FDA 510(k)
FDA Class 2 ·Cardiovascular

TRANSANAL ENDOSCOPIC MICROSURGERY (TEM) COMBINATION SYSTEM AND INSTRUMENT SET, INSTRUMENT SET FOR THE TRANSANAL ENDOSCOP

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

AUTOSOFT XC

FDA Adverse Event
Malfunction ·UNOMEDICAL UM-D·Product code FPA·January 30, 2025

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·January 26, 2012

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·January 26, 2012

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDIC INC.·Product code KWP·October 15, 2009

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDIC INC.·Product code KWP·December 31, 2009

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDIC INC.·Product code KWP·October 29, 2009

HEARTSTART MRX - EMS DEFIBRILLATOR

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 26, 2014

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 14, 2013

CAREASSIST BED

FDA Adverse Event
Malfunction ·HILL-ROM PLUVIGNER·Product code FNL·February 22, 2011

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·May 21, 2010

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·May 21, 2010

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDIC INC.·Product code KWP·August 13, 2010

EVOLUT FX DCS

FDA Adverse Event
Malfunction ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·June 25, 2025

smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024