13 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Tens & Ems Device
FDA 510(k)
FDA Class 2
·Neurology
GelFlex Wrist Support
FDA UDI
MEDICAL SPECIALTIES INCORPORATED·00802357238255·
Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A
FDA 510(k)
FDA Class 2
·Anesthesiology
FILM PROCESSOR, MODEL LIFE RAY PRO 2500
FDA 510(k)
FDA Class 2
·Radiology
IDENTITY SR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·November 10, 2008
FIXODENT DENTURE ADHESIVE, VERSION UNK (CALCIUM ZINC GANTREZ SALT 33% CELLULOSE
FDA Adverse Event
Other
·PROCTER & GAMBLE MANUFACTURING CO.·Product code KOO·August 18, 2011
840 VENTILATOR
FDA Adverse Event
Injury
·COVIDIEN·Product code CBK·July 10, 2013
SYRINGE 10ML REG PR SALINE 10ML FILL
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·May 20, 2021
SYRINGE 10ML REG PR SALINE 10ML FILL
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·May 25, 2021
BD POSIFLUSH NORMAL SALINE SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·February 5, 2021
10 ML BD POSIFLUSH NORMAL SALINE SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·June 1, 2021
ACTIVA
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·February 4, 2016
Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
FDA Enforcement
Class II
·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026