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

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STERISPINE PS

FDA 510(k)
FDA Class 2 ·Orthopedic

MaxFuse,VBR, 12 (D) x 14 (W) x 29 (H)

FDA UDI
Pioneer Surgical Technology, Inc.·00846468056216·VBR, 12 (D) x 14 (W) x 29 (H)

SBI WRISTFIT

FDA 510(k)
FDA Class 2 ·Orthopedic

BRAUN THERMOSCAN PRO 4000 SERIES AND BRAUN THERMOSCAN IRT 4000 SERIES MODEL 6021791-PRO 4000 SERIES, 6022790-IRT 4000 SE

FDA 510(k)
FDA Class 2 ·General Hospital

PASSEO-18 5/200/90

FDA Adverse Event
Malfunction ·BIOTRONIK AG, BUELACH, SWITZERLAND·Product code LIT·September 28, 2021

PASSEO-18 6/200/90

FDA Adverse Event
Malfunction ·BIOTRONIK AG, BUELACH, SWITZERLAND·Product code LIT·September 28, 2021

PASSEO-18 2.5/170/130

FDA Adverse Event
Malfunction ·BIOTRONIK AG, BUELACH, SWITZERLAND·Product code LIT·January 20, 2021

DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

FDA Adverse Event
Malfunction ·RICE CREEK MFG·Product code OJX·June 7, 2013

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·July 6, 2011

VERSACARE

FDA Adverse Event
Malfunction ·HILL-ROM RITTER·Product code FNL·September 10, 2008

CONTOUR® NEXT

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code JJX·September 4, 2025

AXIUM

FDA Adverse Event
Malfunction ·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·October 10, 2019

AXIUM

FDA Adverse Event
Malfunction ·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·October 10, 2019

AXIUM

FDA Adverse Event
Malfunction ·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·October 10, 2019

AXIUM

FDA Adverse Event
Malfunction ·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·October 11, 2019

CONTOUR® PLUS

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code JJX·February 20, 2025

Medical Linear Accelerator

FDA Enforcement
Class II ·Terminated·Elekta, Inc.·September 14, 2016