18 results · 26ms · Sources: EU EUDAMED, US FDA

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ARDIS INTERBODY SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

SILK'N FLASH N GO

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

LATERAL ANGIOGRAPHIC C-ARM SUPPORT MH-400

FDA 510(k)
FDA Class 2 ·Radiology

GYNNIE OB-GYN STRETCHER

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code HDD·May 4, 2011

TWINLOOP FLEX DISPOSABLE DRILL

FDA Adverse Event
Malfunction ·STRYKER ENDOSCOPY-SAN JOSE·Product code LXH·May 29, 2013

PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

FDA Adverse Event
Injury ·ABBOTT VASCULAR REDWOOD CITY·Product code MGB·August 22, 2008

MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·April 4, 2018

MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·November 15, 2017

MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·November 7, 2017

MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·May 15, 2019

MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET

FDA Adverse Event
Injury ·COOK INC·Product code DYB·August 18, 2017

MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·April 4, 2018

MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·April 5, 2018

MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET

FDA Adverse Event
Injury ·COOK INC·Product code DYB·April 11, 2018

MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET

FDA Adverse Event
Injury ·COOK INC·Product code DYB·April 2, 2018

MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET

FDA Adverse Event
Injury ·COOK INC·Product code DYB·March 30, 2018

BD NEXIVA¿ SINGLE PORT CATHETER

FDA Adverse Event
Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·March 20, 2022

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