219 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SUCTION PUMP
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MAXIM KNEE SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304010093·
MAXIM® KNEE SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00887868225079·
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776389994·Working Insert, Albarran Deflecting Mechanism &...
HEMOSTAT KELLY-RANKIN 6 1/4"-CURVED
FDA UDI
W.H. Holden, Inc.·D9281400310·
4.0MHZ PENCIL PROBE 7'
FDA UDI
PARKS MEDICAL ELECTRONICS, INC.·00816787020564·
CERAGEM-C THERMAL ACUPRESSURE MASSAGER
FDA 510(k)
FDA Class 2
·Physical Medicine
IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10
FDA 510(k)
FDA Class 2
·Hematology
REMINGTON I-LIGHT HAIR REMOVAL SYSTEM
FDA Adverse Event
Injury
·SHASER INC·Product code ONF·May 21, 2021
MAXZERO
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FPA·March 17, 2026
EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE / P140031
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·August 30, 2023
EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE / P140031
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·August 10, 2023
AORTIC AP
FDA Adverse Event
Injury
·MEDTRONIC ATS MEDICAL·Product code LWQ·May 31, 2013
LOW RECIRCULATION VOLUME APDSET W/CASSETTE
FDA Adverse Event
Malfunction
·PLASTI ESTERIL, S.A. DE C.V.·Product code FKX·June 25, 2011
VITALITY 2
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 3, 2014
EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE / P140031
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·March 6, 2024
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES
BD MAXZERO¿ MULTI-FUSE PRESSURE RATED EXTENSION SET
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·March 21, 2023
AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·March 16, 2018
EDWARDS SAPIEN 3 ULTRA RESILIA TRANSCATHETER HEART VALVE / P140031
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·August 6, 2024