21 results
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27ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SYSTEM 1E Liquid Chemical Sterilant Processing System
FDA 510(k)
FDA Class 2
·General Hospital
CoRoent
FDA UDI
Nuvasive, Inc.·00887517638823·CoRoent Ant TLIF PEEK, 8x10x34mm 12°
QCT Pro Asynchronous Calibration Module, CliniQCT
FDA UDI
MINDWAYS SOFTWARE, INC.·B052DIASYNC0·The QCT Pro Asynchronous Calibration Module is ...
MAESTRO TOTAL WRIST
FDA UDI
Biomet Orthopedics, LLC·00880304479517·
Maestro™ Total Wrist
FDA UDI
Biomet Orthopedics, LLC·00887868239694·
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197080873·SAROT Needle holder, straight
180 mm...
BYTE DAY ALIGNERS
FDA Adverse Event
Malfunction
·STRAIGHT SMILE, LLC·Product code NXC·October 31, 2024
YOLO CURVE
FDA 510(k)
FDA Class 2
·Physical Medicine
NIHON KOHDEN BEDSIDE MONITOR, MODEL BSM-6000S SERIES
FDA 510(k)
FDA Class 2
·Cardiovascular
OSSURE LOEP KIT
FDA Adverse Event
Death
·AGNOVOS HEALTHCARE USA, LLC·Product code MQV·December 27, 2018
OSSURE LOEP KIT
FDA Adverse Event
Death
·AGNOVOS HEALTHCARE USA, LLC·Product code MQV·January 18, 2020
AXIUM 3-D DETACHABLE COIL
FDA Adverse Event
Injury
·EV3 NEUROVASCULAR·Product code HCG·July 27, 2011
UPHOLD VAGINAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 20, 2013
ALARIS PC UNIT
FDA Adverse Event
Injury
·CAREFUSION CORP.·Product code FRN·October 7, 2014
LIFE SCOPE PT
FDA Adverse Event
Malfunction
·NIHON KOHDEN CORPORATION·Product code MHX·December 26, 2023
LIFE SCOPE PT
FDA Adverse Event
Malfunction
·NIHON KOHDEN CORPORATION·Product code MHX·December 8, 2023
Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·July 13, 2022
Artis icono biplane with software VE20C-diagnostic imaging angiography system Model: 11327600
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·February 2, 2022
Artis icono biplane- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging and interventional procedures. Model: 11327600
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022
syngo Application software VE20 (Material Number 10848815) installed on the Artis pheno and Artis icono systems as follows: (1) Artis pheno Model Number:10849000 (2) Artis icono biplane Model Number: 11327600 (3) Artis icono floor Model Number: 11327700
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·July 13, 2022