13 results · 21ms · Sources: EU EUDAMED, US FDA

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MINIENDO III

FDA 510(k)
FDA Class 2 ·Dental

CAMLOG

FDA UDI
Preat Corporation·00842092125199·CAMLOG® Screw-Line-compatible 6.0mm Blue Light ...

QUASAR

FDA UDI
Modus Medical Devices Inc·G34350036400·Elekta APM Rigid target insert – Gel Filled

SCANLAN®

FDA UDI
SCANLAN INTERNATIONAL INC·00846159019568·DeBakey Ductus Clamp

BIOSOFT RESIN

FDA 510(k)
FDA Class 2 ·Dental

FREEDOM AUTOMATIC FILM PROCESSOR

FDA 510(k)
FDA Class 2 ·Radiology

4.5MM DCP HIP DRILL NEUTRAL & LOAD 60MM

FDA Adverse Event
Malfunction ·SYNTHES GMBH·Product code FZX·February 28, 2013

EX-PRESS MINI GLAUCOMA SHUNT

FDA Adverse Event
Injury ·OPTONOL, LTD·Product code KYF·February 24, 2011

PROXIMATE ILS CURVED CIR STAPL

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

smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP

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

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