71 results · 32ms · Sources: EU EUDAMED, US FDA

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UD IMPLANT SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

OsteoMed

FDA UDI
OSTEOMED LLC·00845694055420·1.6mm Orbital Floor Plate, Preformed, Left, .25...

K131982

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·February 23, 2024

S 100 PEDICLE SCREW SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

LIPOPROTEIN CALIBRATOR

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

BIPAP PRO BIFLEX

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·March 2, 2026

DREAMSTATION BIPAP AUTOSV

FDA Adverse Event
Malfunction ·RESPIRONICS, INC·Product code MNS·March 30, 2022

REMSTAR SYSTEM ONE 60 SERIES

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·October 31, 2024

REMSTAR SYSTEM ONE 60 SERIES

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·January 19, 2026

REMSTAR AUTO

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·August 20, 2021

REMSTAR PRO

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·August 20, 2021

DREAMSTATION BIPAP AUTOSV

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code MNS·March 30, 2022

OMNILAB ADVANCED PLUS

FDA Adverse Event
Malfunction ·RESPIRONICS, INC·Product code MNS·March 31, 2022

REMSTAR PLUS

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·January 5, 2026

REMSTAR AUTOA-FLEX

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·May 20, 2022

REMSTAR AUTO A-FLEX W/HUMID

FDA Adverse Event
Malfunction ·RESPIRONICS, INC·Product code BZD·August 10, 2021

REMSTAR PLUS C-FLEX

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·January 5, 2026

HAHN TAPERED IMPLANT Ø4.3 X 13 MM

FDA Adverse Event
Injury ·PRISMATIK DENTALCRAFT, INC·Product code DZE·December 2, 2024

DREAMSTATION BIPAP AUTOSV

FDA Adverse Event
Malfunction ·RESPIRONICS, INC·Product code MNS·March 30, 2022

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·May 28, 2025