52 results · 32ms · Sources: EU EUDAMED, US FDA

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COMPUMEDICS SOMTE PSG RECORDING SYSTEM

FDA 510(k)
FDA Class 2 ·Anesthesiology

SOLIDEA

FDA UDI
CALZIFICIO PINELLI SRL·08300496072201·BE YOU STEP-UP CURVY, SIZE S-XL, NERO, OPAQUE M...

Genius Total Knee System

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215021580·

PREMICRON NONABSORBABLE PET SURGICAL SUTURE

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

ELECTROSTATIC HYDROPHOBIC BREATHING FILTER

FDA 510(k)
FDA Class 2 ·Anesthesiology

Crescendo Meniscal Insert CR Ultracongruent 10mm Size 1

FDA UDI
AMPLITUDE SAS·03701089524599·

SPRINT QUATTRO SECURE S MRI SURESCAN

FDA Adverse Event
Injury ·MPRI·Product code LWS·February 6, 2024

OT PING METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 23, 2013

ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - CORK·Product code MCX·April 28, 2011

SPRINT

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·July 10, 2008

LEAD MODEL 303

FDA Adverse Event
Malfunction ·LIVANOVA USA, INC.·Product code MUZ·November 16, 2021

LEAD MODEL 304

FDA Adverse Event
Malfunction ·LIVANOVA USA, INC.·Product code LYJ·August 29, 2025

INFINION CX

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·March 5, 2020

LEAD MODEL 300

FDA Adverse Event
Malfunction ·CYBERONICS - HOUSTON·Product code LYJ·March 31, 2025

LEAD MODEL 304

FDA Adverse Event
Malfunction ·LIVANOVA USA, INC.·Product code LYJ·August 8, 2025

LEAD MODEL 304

FDA Adverse Event
Malfunction ·LIVANOVA USA, INC.·Product code LYJ·July 13, 2021

Dual Tip Marker, Sterile Product Usage: A writing instrument intended to mark paper and plastic items around the sterile field during surgery. It has two tips. One is black for miscellaneous use. The other is for surgical skin marking.

FDA Enforcement
Class III ·Terminated·Viscot Medical LLC·April 10, 2013

CAPSUREFIX NOVUS LEAD MRI SURESCAN

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO VILLALBA·Product code DTB·November 15, 2025

LEAD MODEL UNKNOWN

FDA Adverse Event
Malfunction ·LIVANOVA USA, INC.·Product code LYJ·July 7, 2023

PREMICRON GREEN 4/0(1,5)4X45 HR13 TOM

FDA Adverse Event
Malfunction ·B.BRAUN SURGICAL SA·Product code GAT·January 29, 2020