79 results
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37ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ASAHI Neurovasulature Guide Wire: ASAHI CHIKAI black 18 soft tip
FDA 510(k)
FDA Class 2
·Cardiovascular
AMIGO INSULIN PUMP
FDA 510(k)
FDA Class 2
·General Hospital
XELIS FUSION
FDA 510(k)
FDA Class 2
·Radiology
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·October 14, 2014
PROTECT SLEEVE 16/11 F/PFNA BLADE
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code FZX·June 15, 2013
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 21, 2011
ILAB? POLARIS MULTI-MODALITY GUIDANCE SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQK·May 14, 2026
LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DQX·October 8, 2020
NEU_INTERSTIM_INS
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code EZW·August 16, 2017
LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DQX·June 15, 2021
LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE
FDA Adverse Event
Malfunction
·Product code DQX·October 28, 2021
NEU_INTERSTIM_INS
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code EZW·August 16, 2017
LUNDERQUIST EXTRA-STIFF STRAIGHT EXCHANGE SUPPORT WIRE GUIDE
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DQX·February 1, 2022
LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE
FDA Adverse Event
Death
·WILLIAM COOK EUROPE·Product code DQX·March 23, 2022
LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DQX·September 17, 2019
UNKNOWN
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DQX·September 17, 2019
UNKNOWN
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DQX·December 4, 2019
LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE
FDA Adverse Event
Death
·WILLIAM COOK EUROPE·Product code DQX·July 18, 2019
Piston Syringe and Hypodermic Needle, 1 CC TB 28 G X 0.5, 100 per box, 30 boxes/case, 3,000/case
FDA Enforcement
Class II
·Terminated·International Medsurg Connection, Inc.·August 16, 2017
Syringe Bulb, 60 CC 50 pcs per case. The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.
FDA Enforcement
Class II
·Terminated·International Medsurg Connection, Inc.·August 16, 2017