23 results · 25ms · Sources: EU EUDAMED, US FDA

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EVOLVE EPS ORTHOLOC

FDA 510(k)
FDA Class 2 ·Orthopedic

PGI

FDA UDI
Nuvasive, Inc.·00887517419590·PGI Curette, Straight

OsteoMed

FDA UDI
OSTEOMED LLC·00845694025850·Genio Plate, 10mm, Rigid

Vilex Guidewire

FDA UDI
VILEX IN TENNESSEE, INC.·00841731120342·Guidewire 1.4x100mm Sgl Trocar

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450172117·

M SEIRES PATIENT MONITOR MODEL M66, M69, M8000, M9000, M7000

FDA 510(k)
FDA Class 2 ·Cardiovascular

ENA EIA KIT RANGE

FDA 510(k)
FDA Class 2 ·Immunology

ELECTRONIC GAS BLENDER

FDA Adverse Event
Malfunction ·LIVANOVA DEUTSCHLAND·Product code DTX·November 19, 2025

STOCKERT S3 GAS BLENDER

FDA Adverse Event
Other ·SORIN GROUP DEUTSCHLAND·Product code DTQ·December 22, 2014

DEPUY ASR XL FEM IMP SIZE 43

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL·Product code KWA·May 8, 2013

TERUMO ADVANCED PERFUSION SYSTEM 1

FDA Adverse Event
Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·May 16, 2011

PROXIMATE RELOADABLE LINEAR CUTTER WITH SAFETY LOCK-OUT, 100 MM

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, INC (CINCINNATI)·Product code GDW·August 5, 2008

S3 GAS BLENDER SYSTEM

FDA Adverse Event
Malfunction ·LIVANOVA DEUTSCHLAND·Product code DTX·October 16, 2017

S3 GAS BLENDER SYSTEM

FDA Adverse Event
Malfunction ·LIVANOVA DEUTSCHLAND·Product code DTX·October 16, 2017

S3 ELECTRONIC GAS BLENDER

FDA Adverse Event
Malfunction ·LIVANOVA DEUTSCHLAND·Product code DTX·December 19, 2024

SORIN S3 GAS BLENDER

FDA Adverse Event
Malfunction ·SORIN GROUP DEUTSCHLAND·Product code DTX·February 25, 2015

Separation Technology Creamatocrit Plus, Catalog Number: 100-146

FDA Recall
Terminated ·Product code QEI·March 16, 2022

Professional Urine Drug Control, Item code 88010 - Product Usage: The Alere Professional Cup Urine Drug Controls are compatible with all quantitative and qualitative drug detection procedures which are sufficiently sensitive to detect the control constituents.

FDA Enforcement
Class II ·Terminated·Cardinal Health Inc.·May 27, 2020

Separation Technology Creamatocrit Plus, Catalog Number: 100-146

FDA Enforcement
Class II ·Terminated·Stanbio Laboratory, LP·April 20, 2022

WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code NGV·July 12, 2022