21 results
·
37ms
·
Sources: EU EUDAMED, US FDA
EZ-OX PLUS GENERATION II
FDA 510(k)
FDA Class 1
·Anesthesiology
3.5MM CORTEX SCREW SELF-TAPPING 55MM
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code HWC·January 26, 2017
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWC·July 25, 2018
VIGILANT EEG MONITOR MODEL VIGILANT 2.0
FDA 510(k)
FDA Class 2
·Neurology
LALAN GLOVES (PVT) LTD GLOVE, PATIENT EXAMINATION, LATEX
FDA 510(k)
FDA Class 1
·General Hospital
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·November 18, 2015
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWC·June 7, 2018
3.5MM CORTEX SCREW SELF-TAPPING 16MM
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·January 6, 2016
3.5MM CORTEX SCREW SELF-TAPPING 14MM
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·January 6, 2016
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 1, 2014
ENDO GIA MEDIUM/THICK RADIAL RELOAD
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SURGICAL·Product code GDW·May 13, 2013
VITA 2 DDDR
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code DXY·June 16, 2011
CORTSCR 3.5 SELF-TAP L65 TI
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code HWC·April 29, 2013
3.5MM CORTEX SCREW SELF-TAPPING 22MM
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·December 21, 2015
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HWC·January 4, 2016
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·July 14, 2016
3.5MM TI CORTEX SCREW 36MM
FDA Adverse Event
Malfunction
·SYNTHES TRAUMA : OBERDORF : SYNTHES PRODUKTIONS GM·Product code HWC·February 9, 2018
MEDFUSION 3500 SYRINGE INFUSION PUMP
FDA Adverse Event
Malfunction
·ST PAUL·Product code FRN·July 9, 2022
C-QUR MOSAIC
FDA Adverse Event
Injury
·ATRIUM MEDICAL CORPORATION·Product code FTL·October 9, 2015
Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.
FDA Enforcement
Class I
·Terminated·Dexcom Inc·April 20, 2016