59 results · 22ms · Sources: EU EUDAMED, US FDA

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GSO PCT SPINAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450529126·

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450533352·

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450472453·

K091319

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·January 9, 2026

MODIFICATION TO KSEA ENDOTIP SYSTEM

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

DASH 3000/4000 PATIENT MONITOR

FDA 510(k)
FDA Class 2 ·Cardiovascular

REMSTAR AUTO A-FLEX

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·January 12, 2026

REMSTAR AUTO A-FLEX, SYS ONE, 60 SRS, FR

FDA Adverse Event
Injury ·RESPIRONICS, INC·Product code BZD·August 5, 2021

REMSTAR PRO C-FLEX

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·December 31, 2025

REMSTAR

FDA Adverse Event
Injury ·RESPIRONICS, INC.·Product code BZD·October 22, 2024

BIPAP PRO BIFLEX

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

REMSTAR

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·October 28, 2024

DREAMSTATION AUTO CPAP

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·April 10, 2025

REMSTAR PRO C-FLEX+

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·January 7, 2026

OPTISENSE

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, INC. CRMD·Product code DTB·January 14, 2014

2530088-2013-00230

FDA Adverse Event
Injury ·SYNTHES BRANDYWINE·Product code MJO·May 3, 2013

PARADIGM INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code FRN·May 5, 2011

REMSTAR PLUS C-FLEX

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·July 17, 2024

REMSTAR PLUS C-FLEX

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