28 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00681490542425·HANDLE 9150046 TREPHINE DRIVER PEAR
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526768505·GENUMEDI PSS GREEN VI
TMA - Archwire
FDA UDI
ORMCO CORPORATION·00889989029604·TMA REV.CURVE/LOOPS 019X025 40MM PK/5
Electrical Impedance Spectrometer
FDA Pre-Market Approval
FDA Class 2
·NEVISENSE
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197057714·FLETCHER Sponge Forceps
24cm, ...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197416719·PELKMANN Sponge Forceps
25cm, ...
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 25, 2024
M SEIRES PATIENT MONITOR MODEL M66, M69, M8000, M9000, M7000
FDA 510(k)
FDA Class 2
·Cardiovascular
REHABILICARE IF 3 WAVE INTERFERENTIAL STIMULATOR SYSTEM, MODEL 7110S
FDA 510(k)
FDA Class 2
·Physical Medicine
RD SET YI
FDA Adverse Event
Malfunction
·MASIMO - 52 DISCOVERY·Product code DQA·March 29, 2021
RD SET DCI
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code DQA·February 10, 2023
Electrical Impedance Spectrometer
FDA Pre-Market Approval
FDA Class 2
·Nevisense
Electrical Impedance Spectrometer
FDA Pre-Market Approval
FDA Class 2
·Nevisense
Electrical Impedance Spectrometer
FDA Pre-Market Approval
FDA Class 2
·Nevisense
Electrical Impedance Spectrometer
FDA Pre-Market Approval
FDA Class 2
·Nevisense
Electrical Impedance Spectrometer
FDA Pre-Market Approval
FDA Class 2
·Nevisense
Electrical Impedance Spectrometer
FDA Pre-Market Approval
FDA Class 2
·Nevisense
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 7, 2014
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 30, 2013