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

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DYNESYS TOP-LOADING SPINAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

ABRAM'S MULTI-DENSITY POLYURETHANE FOAM WOUND DRESSING SYSTEM

FDA 510(k)
FDA Unclassified ·Unknown

VONFLEX HEAVY, VINFLEX LIGHT

FDA 510(k)
FDA Class 2 ·Dental

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·June 5, 2024

ABRAMS MULTIDENSITY POLYURETHAN FOAM WOUND DRESSING SYSTEM

FDA Adverse Event
Other ·DR LEN'S MEDICAL PRODUCTS·Product code FRO·October 11, 2005

PFC SIGMA OV DOME PAT 3PEG 41

FDA Adverse Event
Injury ·9616671 DEPUY (IRELAND)·Product code JWH·May 29, 2013

ACCESS® 2 IMMUNOASSAY SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER, INC.·Product code MXZ·June 19, 2011

TALENT ABDOMINAL STENT GRAFT SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC CARDIO VASCULAR·Product code MIH·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

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