25 results
·
20ms
·
Sources: EU EUDAMED, US FDA
PROGASTRO CD ASSAY
FDA 510(k)
FDA Class 1
·Microbiology
K090539
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code MNS·February 26, 2026
COCAINE DIPSTICK TEST, MODEL D747-A
FDA 510(k)
FDA Class 2
·Clinical Toxicology
GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL
FDA 510(k)
FDA Class 2
·Hematology
BIPAP AUTOSV ADV
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code MNS·March 20, 2022
BIPAP AUTOSV ADVANCED
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code MNS·March 20, 2022
BIPAP AUTOSV ADV
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code MNS·March 20, 2022
DREAMSTATION BIPAP AUTOSV
FDA Adverse Event
Injury
·RESPIRONICS, INC.·Product code MNS·January 16, 2023
BIPAP AUTOSV ADV
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code MNS·March 20, 2022
BIPAP AUTOSV ADV SYSTEM ONE
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code MNS·March 21, 2022
BIPAP AUTOSV ADV
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code MNS·March 12, 2026
BIPAP AUTOSV ADV
FDA Adverse Event
Malfunction
·RESPIRONICS INC·Product code MNS·October 31, 2022
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 20, 2015
QUADRA ASSURA CRT-D, DF4 CONNECTOR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·May 2, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 15, 2014
BIPAP AUTOSV ADVANCED SYSTEM
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code MNS·January 28, 2022
DREAMSTATION BIPAP AUTOSV
FDA Adverse Event
Malfunction
·RESPIRONICS INC·Product code MNS·November 1, 2022
BIPAP AUTOSV ADV
FDA Adverse Event
Malfunction
·RESPIRONICS INC·Product code MNS·November 7, 2022
ISODUR PROSTHESIS HEAD 12/14 32MM XL
FDA Adverse Event
Malfunction
·AESCULAP AG AND CO KG·Product code LPH·March 28, 2014
DREAMSTATION BIPAP AUTOSV
FDA Adverse Event
Malfunction
·RESPIRONICS, INC·Product code MNS·March 30, 2022