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

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FALLER STYLET

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

EVONOS

FDA UDI
Gyrus ACMI, LLC·00821925018501·MCGEE FOOTPLATE HOOK ANTERIOR .50 MM TIP LENGTH...

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450385395·

XINIWAVE, MODEL XW-18

FDA 510(k)
FDA Class 2 ·Neurology

SYDNEY IVF BLASTOCYST CRYOPRESERVATION KIT AND SYDNEY IVF BLASTOCYST THAW KIT

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

GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 3 / 12 MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·February 28, 2018

CORDLESS DRIVER 3

FDA Adverse Event
Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code HRX·May 24, 2013

MECHANICAL WALKER, ROLLATOR

FDA Adverse Event
DANYANG MAXTHAI MEDICAL EQUIPMENT·Product code ITJ·September 30, 2014

FLANGE FIXTURE AND ABUTMENT

FDA Adverse Event
Injury ·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·June 16, 2011

H30 HOLMIUM LASER 30 WATT HOLMIUM LASER

FDA Adverse Event
Malfunction ·COOK INC·Product code GEX·October 30, 2017

H30 HOLMIUM LASER 30 WATT HOLMIUM LASER

FDA Adverse Event
Malfunction ·COOK INC·Product code GEX·February 9, 2018

H30 HOLMIUM LASER 30 WATT HOLMIUM LASER

FDA Adverse Event
Injury ·COOK INC·Product code GEX·February 28, 2018

H30 HOLMIUM LASER 30 WATT HOLMIUM LASER

FDA Adverse Event
Malfunction ·COOK INC·Product code GEX·February 8, 2018

H30 HOLMIUM LASER 30 WATT HOLMIUM LASER

FDA Adverse Event
Injury ·COOK INC·Product code GEX·April 25, 2018

Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024

Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

FDA Enforcement
Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015

The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.

FDA Enforcement
Class II ·Ongoing·Abbott Medical·January 1, 2025