18 results · 30ms · Sources: EU EUDAMED, US FDA

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7D Surgical System

FDA 510(k)
FDA Class 2 ·Neurology

MAESTRO TOTAL WRIST

FDA UDI
Biomet Orthopedics, LLC·00880304479494·

Maestro™ Total Wrist

FDA UDI
Biomet Orthopedics, LLC·00887868239779·

DIAGNOSOFT HARP MODEL 2.06

FDA 510(k)
FDA Class 2 ·Radiology

MICRO QA+ ANCHOR WITHT #3-0 ORTHOCORD SUTURE, MODEL 212843, MICROFIX AQ+ ANCHOR WITH #3-0 ORTHOCORD SUTURE

FDA 510(k)
FDA Class 2 ·Orthopedic

LIGAMAX CLIP APPLIER

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·October 17, 2014

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·June 20, 2013

OXFORD UNICOMPARTMENTAL KNEE PHASE 3 ANATOMIC ARCOM MENISCAL BEARING

FDA Adverse Event
Injury ·BIOMET UK LTD·Product code NRA·July 27, 2011

MODIFIED NOVY CORNUAL CANNULATION SET

FDA Adverse Event
Malfunction ·COOK INC·Product code MOV·March 14, 2024

VITEK® 2 AST-P656 TEST KIT

FDA Adverse Event
Malfunction ·BIOMERIEUX, INC.·Product code LON·December 18, 2018

MODIFIED NOVY CORNUAL CANNULATION SET

FDA Adverse Event
Malfunction ·COOK INC·Product code MOV·January 10, 2024

MODIFIED NOVY CORNUAL CANNULATION SET

FDA Adverse Event
Malfunction ·COOK INC·Product code MOV·November 22, 2024

DUO FLUID CART WITH SMOKE EVACUATOR

FDA Adverse Event
Malfunction ·DORNOCH·Product code JCX·September 17, 2019

Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc·July 13, 2022

Artis icono biplane with software VE20C-diagnostic imaging angiography system Model: 11327600

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·February 2, 2022

Artis icono biplane- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging and interventional procedures. Model: 11327600

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022

Artis icono biplane- Model No. 11327600 Artis icono floor- Model No. 11327700

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc·September 7, 2022

syngo Application software VE20 (Material Number 10848815) installed on the Artis pheno and Artis icono systems as follows: (1) Artis pheno Model Number:10849000 (2) Artis icono biplane Model Number: 11327600 (3) Artis icono floor Model Number: 11327700

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc·July 13, 2022