13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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