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