142 results · 31ms · Sources: EU EUDAMED, US FDA

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Predicate III Guidewire

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

SCANX 14

FDA 510(k)
FDA Class 2 ·Radiology

KYPHON XPEDE BONE CEMENT

FDA 510(k)
FDA Class 2 ·Orthopedic

KYPHX HV-R BONE CEMENT

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NDN·February 25, 2020

SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·October 5, 2014

PROLIFT PELVIC FLOOR REPAIR

FDA Adverse Event
Injury ·ETHICON, INC.·Product code OTP·June 3, 2013

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC MINIMED·Product code MDS·June 21, 2011

KYPHON XPEDE BONE CEMENT

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NDN·November 6, 2019

KYPHON XPEDE BONE CEMENT

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NDN·July 30, 2019

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·June 5, 2025

KYPHX HV-R BONE CEMENT

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NDN·April 2, 2019

KYPHX HV-R BONE CEMENT

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NDN·April 2, 2019

RADIUS-7

FDA Adverse Event
Malfunction ·MASIMO CORPORATION·Product code DQA·July 2, 2015

KYPHX HV-R BONE CEMENT

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NDN·January 9, 2020

ACTIVOS¿ BONE CEMENT

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NDN·October 22, 2024

iCup DX 8 Panel w/Adulterant, Item No. I-DXA-187-016

FDA Enforcement
Class III ·Terminated·Ameditech Inc·December 30, 2015

KYPHON XPEDE BONE CEMENT

FDA Adverse Event
Malfunction ·CARDIAC SURGERY MFG KERKRADE·Product code NDN·November 10, 2025

KYPHON XPEDE BONE CEMENT

FDA Adverse Event
Malfunction ·CARDIAC SURGERY MFG KERKRADE·Product code NDN·November 10, 2025

KYPHON® ACTIVOS¿ BONE CEMENT WITH HYDROXYAPATITE

FDA Adverse Event
Malfunction ·CARDIAC SURGERY MFG KERKRADE·Product code NDN·November 29, 2024

KYPHON® ACTIVOS¿ BONE CEMENT WITH HYDROXYAPATITE

FDA Adverse Event
Malfunction ·CARDIAC SURGERY MFG KERKRADE·Product code NDN·April 29, 2025