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

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NUMED Z-MED PTV CATHERERS

FDA 510(k)
FDA Class 2 ·Cardiovascular

Endo-Model Knee System - Instruments

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575174072·Orthopaedic implant aiming/guiding block, reusa...

TANDEM T:SLIM INSULIN DELIVERY SYSTEM

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE, INC.·Product code LZG·December 11, 2014

VARIS 1.4G

FDA 510(k)
FDA Class 2 ·Radiology

INPLANT ORTHODONTIC ANCHOR SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

LIFEVEST WCD 4000 SYSTEM

FDA Adverse Event
Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·February 11, 2013

LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

FDA Adverse Event
Injury ·ALLERGAN·Product code LTI·February 23, 2011

ENDOSCOPIC MULTIFEED STAPLER - 360 ROTATION 20 TITANIUM STAPLES

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code GCJ·February 14, 2008

smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-68 and REF 14-504-68JP

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024

L3O0200 - NATURA

FDA Adverse Event
Injury ·CONVATEC DOMINICAN REPUBLIC INC·Product code EZQ·November 8, 2021

ASPHERE M SPEC 12/14 36 -2

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·December 14, 2012

L3O0200 - NATURA

FDA Adverse Event
Injury ·CONVATEC DOMINICAN REPUBLIC INC·Product code EZQ·November 8, 2021

CORAIL2 LAT COXA VARA SIZE 12

FDA Adverse Event
Injury ·DEPUY FRANCE SAS - 3003895575·Product code KWL·August 30, 2018

Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

FDA Enforcement
Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS

FDA Enforcement
Class II ·Terminated·Natus Medical Incorporated·December 21, 2016

Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

FDA Enforcement
Class II ·Ongoing·Covidien·August 28, 2024