1,214 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Novalung System
FDA 510(k)
FDA Class 2
·Cardiovascular
OneLIF™
FDA UDI
Novapproach Spine LLC·G07001011914070·OneLIF Interbody, Small, 19 Degree, 14mm X 7mm
OneLIF™
FDA UDI
Novapproach Spine LLC·G07001111914070·Trial-OneLIF Interbody, Small, 19 Degree, 14mm ...
TRIPORT, TRIPORT+, TRIPORT15, QUADPORT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ALPHA HISTOPLASMA ANTIGEN EIA MODEL HAG102
FDA 510(k)
FDA Class 2
·Microbiology
MONOPOLAR CURVED SCISSORSINSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·June 26, 2013
MRH TIB BP PEG EX SML
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS LIMERICK·Product code KRO·July 28, 2011
LIFEPAK CR PLUS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code MKJ·September 26, 2008
DGPHP RFA High-Power Single Use Grounding Pads and Cool-Tip RFA Electrode Kits (containing DGPHP RFA High-Power single use grounding pads) The product is used during ablation surgical procedures.
FDA Enforcement
Class II
·Terminated·Nellcor Puritan Bennett Inc. (dba Covidien LP)·September 5, 2012
ARTIS ZEE III CEILING
FDA Adverse Event
Malfunction
·SIEMENS HEALTHINEERS AG·Product code OWB·May 17, 2024
HEATER-COOLER SYSTEM 3T
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND GMBH·Product code DWC·January 5, 2022
HEATER-COOLER SYSTEM 3T
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DWC·February 11, 2022
HEATER-COOLER SYSTEM 3T
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND GMBH·Product code DWC·August 19, 2020
HEATER-COOLER SYSTEM 3T
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DWC·December 1, 2020
HEATER-COOLER SYSTEM 3T
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DWC·October 27, 2020
HEATER-COOLER SYSTEM 3T
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DWC·November 20, 2020
HEATER-COOLER SYSTEM 3T
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DWC·May 7, 2021
HEATER-COOLER SYSTEM 3T
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND GMBH·Product code DWC·August 21, 2020
ARTIS ZEE III CEILING
FDA Adverse Event
Malfunction
·SIEMENS HEALTHINEERS AG·Product code OWB·December 3, 2024
HEATER-COOLER SYSTEM 3T
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DWC·February 11, 2022