17 results · 23ms · Sources: EU EUDAMED, US FDA

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Uroject12 Syringe Lever

FDA 510(k)
FDA Class 2 ·General Hospital

CoRoent

FDA UDI
Nuvasive, Inc.·00887517638830·CoRoent Ant TLIF PEEK, 8x10x34mm 15°

Maestro™ Total Wrist

FDA UDI
Biomet Orthopedics, LLC·00887868239724·

MAESTRO TOTAL WRIST

FDA UDI
Biomet Orthopedics, LLC·00880304479418·

Millennium

FDA UDI
Avalign Technologies, Inc.·00190776367732·Yasargil Bayonet Tumor Forceps, 5mm sharp cut c...

BYTE DAY ALIGNERS

FDA Adverse Event
Malfunction ·STRAIGHT SMILE, LLC·Product code NXC·October 31, 2024

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197453073·CCR Titanium Lateral Blade 24x45m...

SCANVIEW SYSTEM

FDA 510(k)
FDA Class 2 ·Immunology

SYSTEMS INTEGRATION MODEL: ENDOALPHA

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

REAMER SHAFT, MOD. TRINKLE BIXCUT 8.0 X 284 MM

FDA Adverse Event
Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·December 18, 2012

GYNECARE TVT OBURATOR SYSTEM

FDA Adverse Event
Injury ·ETHICON INC.·Product code OTN·June 20, 2013

NXT DETACHABLE COIL, TETRIS

FDA Adverse Event
Malfunction ·EV3 NEUROVASCULAR·Product code HCG·July 27, 2011

WECK HEMOLOK L CLIPS 6/CART 84/BOX

FDA Adverse Event
Malfunction ·TELEFLEX·Product code MCH·October 15, 2014

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

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