11 results · 20ms · Sources: EU EUDAMED, US FDA

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SMITH & NEPHEW DYONICS LAPAROSCOPY SYSTEM

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

ABBOTT LIFECARE 5000 PUMP MODIFIED

FDA 510(k)
FDA Class 2 ·General Hospital

PROXIMAL FEMUR REPLACEMENT STEM

FDA 510(k)
FDA Class 2 ·Orthopedic

GREENLIGHT ADDSTAT

FDA Adverse Event
Malfunction ·AMS INNOVATION CENTER - SILICON VALLEY·Product code GEX·November 17, 2010

OT PING METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 5, 2014

GO BED PLUS

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code FNL·December 7, 2012

EVOLUT R TRANSCATHETER AORTIC VALVE

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·March 29, 2019

EVOLUT PRO TRANSCATHETER AORTIC VALVE

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·March 29, 2019

EVOLUT PRO TRANSCATHETER AORTIC VALVE

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·October 24, 2019

EVOLUT R TRANSCATHETER AORTIC VALVE

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·October 24, 2019

Siemens Medical Solutions, ACUSON P300 Ultrasound system with P300 PA 230E cardiac probe (Esaote product 7348). Provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc.·April 9, 2014