120 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ePM Series Patient monitors
FDA 510(k)
FDA Class 2
·Cardiovascular
Paradigm
FDA UDI
Proprio, Inc.·00850042604182·Paradigm DRF L-Rod, 150 mm
ReLine
FDA UDI
Nuvasive, Inc.·00195377046987·RELINE-O Trial, 11mm H Lamina W L-pop
Phasix
FDA UDI
Davol Inc.·00801741095290·Phasix ST Mesh, 15 cm (6"), Circle
EVOS Lumbar Interbody System
FDA UDI
Cutting Edge Spine, LLC·00841193113258·HA PEEK EVOS Straight, ,15mmx8mmx 22mm , FLAT ...
BABY LEXER-STRABISMUS SCISSORS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896088146·BABY LEXER-STRABISMUS SCISSORS STRAIGHT BLADE P...
Standard Depth Gauge
FDA UDI
Osteocentric Technologies, Inc.·00810074306393·Standard Depth Gauge
BARCOMED 2MP2
FDA 510(k)
FDA Class 2
·Radiology
IMPLANT GUIDANCE SYSTEM APPLICATOR SET
FDA 510(k)
FDA Class 2
·Radiology
SMR CONNECTOR SMALL STD
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code KWS·June 28, 2022
Pulmonary Valve Prosthesis Percutaneously Delivered
FDA Pre-Market Approval
Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 10, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 17, 2014
SYNCHROMED II
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LKK·July 1, 2013
SAPIEN XT TRANSCATHETER HEART VALVE
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPV·March 13, 2026
Pulmonary Valve Prosthesis Percutaneously Delivered
FDA Pre-Market Approval
Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System
Pulmonary Valve Prosthesis Percutaneously Delivered
FDA Pre-Market Approval
Edwards SAPIEN 3 Transcatheter Heart Valves
Pulmonary Valve Prosthesis Percutaneously Delivered
FDA Pre-Market Approval
Edwards Commander Delivery System
Pulmonary Valve Prosthesis Percutaneously Delivered
FDA Pre-Market Approval
Edwards SAPIEN 3 Transcatheter Heart Valve
Pulmonary Valve Prosthesis Percutaneously Delivered
FDA Pre-Market Approval
Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System