21 results · 24ms · Sources: EU EUDAMED, US FDA

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ClotTriever Thrombectomy System

FDA 510(k)
FDA Class 2 ·Cardiovascular

MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S5 - LATER

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code HSX·December 16, 2020

SURGISEAL TOPICAL SKIN ADHESIVE

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

CAP PLUS, EQUIVABONE, CAP/DBM

FDA 510(k)
FDA Class 2 ·Orthopedic

MPACT FLAT PE HC LINER Ø36/E

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·October 16, 2018

MOTO PARTIAL KNEE TIBIAL INSERT FIX S4 LM - 8MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code HSX·October 26, 2023

COCR FEMORAL BALL HEAD

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·November 18, 2024

OBTRYX SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 20, 2013

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 27, 2011

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 17, 2014

OPTILENE 6/0 (0,7) 75CM 2XDRC13 CV2 RCP

FDA Adverse Event
Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAW·December 9, 2025

OPTILENE 7/0 (0,5) 60CM 2XDRC8 CV2 RCP

FDA Adverse Event
Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAW·December 9, 2025

Interventional Fluoroscopic X-Ray System ARTIS icono biplane- 11327600 ARTIS icono floor- 11327700 ARTIS pheno- 10849000 ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·May 5, 2021

Artis icono biplane -angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327600

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc·June 15, 2022

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

BIOMET StageOne Hip Cement Spacer Mold with Insert, 60 MM, Silicone, Sterile, Item 431184.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020

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

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

ROSA Brain 3.0 Application-Brain

FDA Enforcement
Class II ·Terminated·MEDTECH SAS·February 19, 2020