25 results · 21ms · Sources: EU EUDAMED, US FDA

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LIAISON VZV IgG HT, LIAISON Control VZV IgG HT

FDA 510(k)
FDA Class 2 ·Microbiology

Dornier MedTech

FDA UDI
DORNIER MEDTECH AMERICA, INC.·00810116022601·Dornier 600 µm Single-Use SMA UroBeam Diode Las...

CRANIAL MAP NEURO

FDA 510(k)
FDA Class 2 ·Neurology

CYCLONE ANTERIOR CERVICAL PLATE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code OZO·January 12, 2022

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·January 12, 2022

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·January 21, 2022

DRILL, AO, STERILE 4, 2X340 MM

FDA Adverse Event
Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·September 23, 2011

COCHLEAR OSIA OSI300 IMPLANT

FDA Adverse Event
Injury ·COCHLEAR LTD·Product code PFO·March 8, 2026

COCHLEAR OSIA OSI300 IMPLANT

FDA Adverse Event
Injury ·COCHLEAR LTD·Product code PFO·January 15, 2024

COCHLEAR OSIA OSI300 IMPLANT

FDA Adverse Event
Injury ·COCHLEAR LIMITED·Product code PFO·January 15, 2024

FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·November 17, 2008

IN TOUCH ZU

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code FNL·July 18, 2011

CONNEC-ROD Ø6/3.5 L500 Ø6/250 Ø3.5/240 T

FDA Adverse Event
Malfunction ·SYNTHES MONUMENT·Product code KWP·July 17, 2013

IPS e.max ZirCAD CER/in. Prime A3 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth Article Number: 758439

FDA Enforcement
Class II ·Ongoing·IVOCLAR VIVADENT AG·May 8, 2024

IPS e.max ZirCAD CER/in. Prime A1 C17/5 - A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758437

FDA Enforcement
Class II ·Ongoing·IVOCLAR VIVADENT AG·May 8, 2024

IPS e.max ZirCAD CER/in. Prime BL1 C17/3- A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758434

FDA Enforcement
Class II ·Ongoing·IVOCLAR VIVADENT AG·May 8, 2024

IPS e.max ZirCAD CER/in. Prime A2 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758438

FDA Enforcement
Class II ·Ongoing·IVOCLAR VIVADENT AG·May 8, 2024

Vue PACS Diagnostic Viewer with Vue PACS client 12.1.5 to 12.2.8.454 software Model Number: 1149418 Intended use is to provide completely scalable local and wide area PACS (Picture Archiving and Communication System) solutions for hospital and related institutions/sites.

FDA Enforcement
Class II ·Ongoing·Philips Medical Systems Technologies Ltd.·November 27, 2024

SIGNA Architect AIR, Nuclear Magnetic Resonance Imaging System

FDA Enforcement
Class II ·Ongoing·GE Medical Systems, LLC·December 4, 2024