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

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

Meron Plus QM

FDA 510(k)
FDA Class 2 ·Dental

FUKUSHIMA SUCTION TUBE

FDA UDI
SONTEC INSTRUMENTS, INC.·B0991803860·FUKUSHIMA SUCTION TUBE

Tibial Alignment Sleeve

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215063702·

BYTE DAY ALIGNERS

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

DISPOSABLE CIRCULAR STAPLER, MODELS WHY-25, WHY-29. WHY 32

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

COLUMBIA 600 ELECTRODE, COLUMBIA 06 LEADWIRE

FDA 510(k)
FDA Class 2 ·Neurology

LIBERTÉ?

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code MAF·June 20, 2013

COLLEAGUE PRE P1.7

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

ACCU-CHEK ® SPIRIT COMBO

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LZG·October 17, 2014

SYRINGE 1.0ML 30GA 1/2IN UF 10BAG 500CS

FDA Adverse Event
Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·May 25, 2021

POLYETHYLENE ANGIOGRAPHIC CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code DQO·April 5, 2022

RELION PEN NEEDLES 4MM X 32 GAUGE

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code FMI·December 12, 2022

RELION PEN NEEDLES 4MM X 32 GAUGE

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code FMI·December 12, 2022

RELION PEN NEEDLES 4MM X 32 GAUGE

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code FMI·December 12, 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- 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

OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

FDA Enforcement
Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012