25 results · 20ms · Sources: EU EUDAMED, US FDA

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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