32 results · 37ms · Sources: EU EUDAMED, US FDA

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HUMMINGBIRD SUBDURAL H900DS (DRAINAGE AND ICP), HUMMINGBIRD SUBDURAL- H800S (ICP ONLY)

FDA 510(k)
FDA Class 2 ·Neurology

ECHOTECH EASY 3D FAMILY, ECHOTECH 3D FREESCAN, ECHOTECH EASYARCHIVE, ECHOTECH QUANTICON, ECHOTECH EASYSTRESS

FDA 510(k)
FDA Class 2 ·Radiology

GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULESWITH PILLCAM R SENSORBELT

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

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

AXIOS

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·December 18, 2024

AXIOS

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·February 19, 2025

REMSTAR AUTO A-FLEX W/HUMID

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

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

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

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

FDA Adverse Event
Injury ·RESPIRONICS INC·Product code BZD·August 30, 2021

AXIOS

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·December 17, 2024

AXIOS

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·February 20, 2025

REMSTAR PRO C-FLEX+

FDA Adverse Event
Malfunction ·RESPIRONICS INC·Product code BZD·February 8, 2022

IMPAX CV OUTBOUND (RESULTS MANGEMENT 2.08)

FDA Adverse Event
Malfunction ·AGFA HEALTHCARE CORP·Product code LLZ·February 28, 2014

HEARTSTART FRX

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 9, 2013

ASR ACETABULAR IMPLANT 50

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·May 18, 2011

REMSTAR PRO C-FLEX+

FDA Adverse Event
Malfunction ·RESPIRONICS INC·Product code BZD·February 8, 2022

AXIOS

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·December 18, 2024

REMSTAR AUTO A-FLEX

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·January 14, 2022

VERSAFITCUP CC TRIO FLAT PE HC LINER Ø 32 / E

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code LZO·June 15, 2022