12 results
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18ms
·
Sources: EU EUDAMED, US FDA
FETAL HEART DETECTOR #D206
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209103768·
OFFICE BASED ANESTHESIA MACHINE, MODEL OBA-1
FDA 510(k)
FDA Class 2
·Anesthesiology
DRF 4343
FDA 510(k)
FDA Class 2
·Radiology
EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code NTE·May 8, 2014
CHARGING SYSTEM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·October 18, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 21, 2007
Acrobat-i Vacuum Positioner System, Model Number XP-5000Z
FDA Recall
Open, Classified
·Maquet Cardiovascular, LLC·Product code MWS·October 31, 2023
QUADROX-i Neonatal without integrated arterial filter and VHK 11000 (VKMO 10000-USA#QUADROX-i Neo.+Reservoir), Part Number 701055120 The membrane oxygenator QUADROXi Neonatal is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery.
FDA Recall
Terminated
·Maquet Cardiovascular Us Sales, Llc·Product code DTZ·October 25, 2018
QUADROX-i Neonatal with integrated arterial filter and VHK 11000 (VKMO 11000-USA#QUADROX-i Neo.+Reservoir), Part Number 701055207 The membrane oxygenator QUADROXi Neonatal is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery.
FDA Recall
Terminated
·Maquet Cardiovascular Us Sales, Llc·Product code DTZ·October 25, 2018
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025