13 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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HORIZON TMS Therapy System
FDA 510(k)
FDA Class 2
·Neurology
NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES AND PROTEIN CLAIM (50 MICROGRAMS OR LESS) MODEL: WHITE: X-SMALL, SMALL
FDA 510(k)
FDA Class 1
·General Hospital
PALOMAR ICON (TM) AESTHETIC SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 5
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·March 18, 2020
CERTAS PLUS INLINE WITH SIPHON
FDA Adverse Event
Injury
·INTEGRA LIFESCIENCES SWITZERLAND SAR·Product code JXG·September 14, 2022
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 20, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 27, 2011
INTERSTIM
FDA Adverse Event
Malfunction
·MPROC, JUNCOS·Product code EZW·September 23, 2008
PRODIGY VOICE
FDA Adverse Event
Injury
·OK BIOTECH CO., LTD.·Product code NBW·August 6, 2019
Aligned Medical Solutions, Local Lower Extremity Pack I, AMS10833, STERILEEO
FDA Enforcement
Class I
·Ongoing·Windstone Medical Packaging, Inc.·February 28, 2024
IntelliSpace PACS 4.4, Product number 837507 - Product Usage: intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians.
FDA Enforcement
Class II
·Completed·Philips Healthcare Informatics, Inc.·June 17, 2020
ROSA Brain 3.0 Application-Brain
FDA Enforcement
Class II
·Terminated·MEDTECH SAS·February 19, 2020
Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·February 26, 2020