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