17 results · 29ms · Sources: EU EUDAMED, US FDA

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BPC-3000 PERSONAL BLOOD PRESSURE COMMUNICATOR, MODEL 52520

FDA 510(k)
FDA Class 2 ·Cardiovascular

Vital Signs

FDA UDI
Carefusion Finland 320 Oy·70885403255252·Low Dead Space Adapter, 4.0 mm

Creation Willi Geller

FDA UDI
KLEMA Dentalprodukte GmbH·09010782022641·CC/ Opaque Dentine OD-43 (ivory)

Creation Willi Geller

FDA UDI
KLEMA Dentalprodukte GmbH·ECWG0015431·CC/ Opaque Dentine OD-43 (ivory)

artVeneer life

FDA UDI
Merz Dental GmbH·D7092001543·artVeneer life upper anteriors, IM, BL1

Scanlan® VASCU-STATT® II approximator single-use bulldog clamp w/firmr pres

FDA UDI
SCANLAN INTERNATIONAL INC·00846159000580·Scanlan® VASCU-STATT® II approximator single-us...

CONTEMPRO-MIST

FDA 510(k)
FDA Class 2 ·Anesthesiology

KAWASUMI LABORATORY BLOOD DRAWING KIT

FDA 510(k)
FDA Class 2 ·Hematology

BD SAFETYGLIDE¿ NEEDLE

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMI·February 25, 2019

BHR

FDA Adverse Event
Injury ·SMITH & NEPHEW ORTHOPAEDICS LTD·Product code NXT·March 13, 2013

CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code DYE·February 25, 2011

INFINITI VISION SYSTEM

FDA Adverse Event
Injury ·ALCON -IRVINE TECHNOLOGY CENTER·Product code HQE·February 21, 2008

Sunrise Brand Zippie Voyage, Chair with Casters, Early Intervention Device (Stroller), Model: EIZ14; Product is manufactured and distributed by Sunrise Medical (US) LLC., Fresno, CA. Used by a person to move from one place to another while sitting.

FDA Enforcement
Class II ·Terminated·Sunrise Medical (US) LLC·December 11, 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

1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

FDA Enforcement
Class II ·Ongoing·B-K Medical A/S·November 12, 2025

Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

FDA Enforcement
Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013

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

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