18 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Yushan X-Ray Flat Panel Detector with DROC
FDA 510(k)
FDA Class 2
·Radiology
N/A
FDA UDI
HANS RUDOLPH, INC.·00874750003969·SWVL PORT ASY 7700 22ID PC YEL
FAC-4 - Duke Power Cabinet
FDA UDI
Certified Safety Manufacturing, Inc.·00766588015293·FAC-4 - Duke Power Cabinet
ABSORBENT PAPER POINTS
FDA UDI
DiaDent Group International·08806383512138·"An absorbent paper points is an endodontic pap...
Tecomet
FDA UDI
TECOMET INC.·00841435120839·SCREW HOLDING FORCEP
APPLE ECG (ELECTROCARDIOGRAPH) APP
FDA Adverse Event
Injury
·APPLE INC.·Product code QDA·July 5, 2023
WALLACH ULTRA FREEZE
FDA Adverse Event
Malfunction
·COOPERSURGICAL, INC.·Product code GEH·November 25, 2019
REPROCESSED VENODYNE SEQUENTIAL COMPRESSION SLEEVES / WRAP
FDA 510(k)
FDA Class 2
·Cardiovascular
PC FLOW +
FDA 510(k)
FDA Class 2
·Anesthesiology
WALLACH ULTRA FREEZE
FDA Adverse Event
Malfunction
·COOPERSURGICAL, INC.·Product code GEH·March 19, 2020
WALLACH ULTRA FREEZE
FDA Adverse Event
Malfunction
·COOPERSURGICAL, INC.·Product code GEH·July 1, 2019
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code NIQ·October 17, 2008
ENRHYTHM DR
FDA Adverse Event
Malfunction
·MEDTRONIC S.A.·Product code DXY·August 11, 2011
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 2, 2013
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
FDA Adverse Event
Injury
·ANIMAS CORP·Product code LZG·January 26, 2011
WALLACH ULTRA FREEZE
FDA Adverse Event
Malfunction
·COOPERSURGICAL, INC.·Product code GEH·November 19, 2019
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012