19 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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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