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

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TETRACHROME REAGENTS AND TETRACXP SYSTEM

FDA 510(k)
FDA Class 2 ·Hematology

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587X1214450·12mm H x 14mm W x 45mm L x 0 degrees XLIF

Lasik Sweep

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896103023·Cornell Lasik Sweep Single End Semi Sharp Tip T...

TALOS® IBF

FDA UDI
MEDITECH SPINE, LLC·B16741214450·

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587X12144580·12mm H x 14mm W x 45mm L x 8 degrees XLIF

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587X121445120·12mm H x 14mm W x 45mm L x 12 degrees XLIF

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587L121445120·12mm H x 14mm W x 45mm L XLIF Trial 12 degree L...

SafeGuide®

FDA UDI
DIVERSATEK HEALTHCARE, INC.·00816734021132·Esophageal Dilator, 45 French

TALOS® IBF

FDA UDI
MEDITECH SPINE, LLC·B1674121445060·

UniTip High Resolution Catheter

FDA UDI
Unisensor AG·07640172970386·

MaxFuse VBR, 10 (D) x 12 (W) x 55 (H)

FDA UDI
Pioneer Surgical Technology, Inc.·00846468055653·10 (D) x 12 (W) x 55 (H)

ETEST CEFDITOREN FOR S. PNEUMONIAE AND H. INFLUENZAE

FDA 510(k)
FDA Class 2 ·Microbiology

VITAL SIGNS MONITOR-VSM 6000 SERIES

FDA 510(k)
FDA Class 2 ·Cardiovascular

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 20, 2013

CONSTELLATION VISION SYSTEM

FDA Adverse Event
Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·July 29, 2014

BIVONA CUSTOM TTS HYPERFLEX TRACHEOSTOMY TUBE

FDA Adverse Event
Malfunction ·SMITHS MEDICAL ASD, INC.·Product code JOH·May 6, 2011

Artis Q (material 10848280, 10848281, 10848282) - Product Usage: AXIOM Artis zee and Q/ Q.zen 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. Procedures that can be performed with the AXIOM Artis zee and Q/ Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis zee and Q/ Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis.

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·May 22, 2019

Artis Q Biplane, Model No. 10848282; Artis Q Ceiling, Model No.10848281; Artis Q Floor, Model No. 10848280; Artis Q zeego, Model No. 10848283 Product Usage: 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·March 25, 2020

Artis Q biplane, Model Number 10848282

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

Artis Q. angiography system. Model 10848280, 10848281, 10848282, 10848283, 10848353, 10848354 & 10848355 Product Usage: 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. Procedures that can be performed with the Artis family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis can also support the acquisition of position triggered imaging for spatial data synthesis.

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·August 22, 2018