17 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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2cm Peripheral Cutting Balloon Microsurgical Dilatation Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Oticon
FDA UDI
Oticon A/S·05707131288004·ALTA2 PRO, DESIGNRITE 10 WL THP
SYRINGE 50ML LL TIP 1ML
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·July 15, 2024
BD TUBE SST PLH 13X100 5.0 PLBL GOLD BR
FDA Adverse Event
Malfunction
·BECTON DICKINSON IND. CIRURGICAS LTDA·Product code JKA·April 21, 2023
RII INFRARED EAR THERMOMETER, MODEL: TH60N
FDA 510(k)
FDA Class 2
·General Hospital
MODIFICATION TO: MULTIRATE INFUSOR SV )WITH AND WITHOUT PCM), MULTIRATE INFUSOR LV (WITH AND WITHOUT PCM)
FDA 510(k)
FDA Class 2
·General Hospital
840 VENTILATOR
FDA Adverse Event
Injury
·COVIDIEN·Product code CBK·June 20, 2017
840 VENTILATOR
FDA Adverse Event
Injury
·COVIDIEN·Product code CBK·August 1, 2017
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN·Product code CBK·July 25, 2017
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN·Product code CBK·August 17, 2017
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN·Product code CBK·March 21, 2017
CONNECSCR F/INSERTION DHS BLADE
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code LXH·June 7, 2013
UNKNOWN HIP HEAD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWY·June 30, 2011
MINICAP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - GUANGZHOU·Product code KDI·October 8, 2014
840 VENTILATOR
FDA Adverse Event
Injury
·COVIDIEN·Product code CBK·June 26, 2017
Precise Treatment Table. To be used as part of radiation therapy treatment process.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·April 17, 2013
All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 12, 2014