16 results · 22ms · Sources: EU EUDAMED, US FDA

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Spinal Manometer NRFit; Spinal Manometer LUER

FDA 510(k)
FDA Class 2 ·General Hospital

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04064984699571·GENUMEDI PSS BLUE, SIZE V

LOCATOR F-Tx

FDA UDI
Zest Anchors, LLC·00840481121951·LOCATOR F-Tx Abutment For 4.05mm Platform Exter...

Denovo Preformed Matrix Band

FDA UDI
Denovo Dental, Inc.·00810059290853·Denovo Preformed Matrix Band - Pediatric 3/16, ...

ALERE DETERMINE HIV 1/2 AG/AB COMBO

FDA Adverse Event
Malfunction ·ALERE SCARBOROUGH INC.·Product code MZF·June 12, 2018

ALERE DETERMINE HIV 1/2 AG/AB COMBO

FDA Adverse Event
Malfunction ·ALERE SCARBOROUGH INC.·Product code MZF·June 12, 2018

PRE-LOADED VISICOIL

FDA 510(k)
FDA Class 2 ·Radiology

ETURN SPINAL IMPLANT MODEL ETURN XX-12; ETURN XX-16 WHERE XX=07, 09, 11, 13, OR 15 AND ETURN XX-12 K; ETURN XX-16 K WHER

FDA 510(k)
FDA Class 2 ·Orthopedic

ECHELON*FLEX60

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·June 14, 2013

FINELINE II

FDA Adverse Event
Injury ·CPI - DEL CARIBE·Product code NVN·July 20, 2011

ENDO CATCH

FDA Adverse Event
Malfunction ·UNITED STATES SURGICAL CORP. (COVIDIEN)·Product code GCJ·September 12, 2008

KIT BD MAX EXT ENTERIC BACTERIAL PANEL

FDA Adverse Event
Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code PCH·June 21, 2022

Artis icono floor-angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327700

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

Artis icono floor with software VE20C-diagnostic imaging angiography system Model: 11327700

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·February 2, 2022

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 floor in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging and interventional procedures. Model: 11327700

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022