21 results · 22ms · Sources: EU EUDAMED, US FDA

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ANGIODYNAMICS SOFT-VU HYDROPHILIC COATED ANGIOGRAPHIC CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

Creation Willi Geller

FDA UDI
KLEMA Dentalprodukte GmbH·ECWG0015781·CC/ Opaque Dentine OD-B4

TruForm

FDA UDI
Rmo, Inc.·00885797099709·MX MLR BDS R/L SE ASIA ASST100

Creation Willi Geller

FDA UDI
KLEMA Dentalprodukte GmbH·09010782022887·CC/ Opaque Dentine OD-B4

artVeneer life

FDA UDI
Merz Dental GmbH·D7092001578·artVeneer life upper anteriors, ITL, BL2

AtriClip PRO-Mini LAA Exclusion System

FDA UDI
ATRICURE, INC.·10840143913594·LAA Exclusion System, PROM50

RESTORE

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 15, 2013

RESTORE

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·October 29, 2013

SERIM LEUKOCYTE ESTERASE TEST STRIPS

FDA 510(k)
FDA Class 1 ·Hematology

SULZER ORTHOPEDICS MS-30 FEMORAL STEM

FDA 510(k)
FDA Class 2 ·Orthopedic

RESTORE

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·July 12, 2012

AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM - ANTERIOR

FDA Adverse Event
Injury ·BARD SHANNON LTD·Product code FTL·March 11, 2013

MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT

FDA Adverse Event
Malfunction ·UNKNOWN·Product code INI·August 12, 2014

COOL PATH DUO 7F, 1304-CP2-7-1.5(5)-L1-TE4BE1AB

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, IRVINE·Product code OAD·January 26, 2011

HANDLE BATTERY POWERED DRIVER

FDA Adverse Event
Malfunction ·SYNTHES GMBH·Product code HWE·December 30, 2024

ONYX

FDA Adverse Event
Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code MFE·August 30, 2023

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

bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic

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

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