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

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Stat Profile Prime Plus Analyzer System

FDA 510(k)
FDA Class 2 ·Hematology

PedFuse®

FDA UDI
SPINEFRONTIER, INC.·00190361014966·Screw Assy REset Solid 6.0X45mm Gen 3

PedFuse®

FDA UDI
SPINEFRONTIER, INC.·00190361014959·Screw Assy REset Solid 6.0X40mm Gen 3

PedFuse®

FDA UDI
SPINEFRONTIER, INC.·00190361014928·Screw Assy REset Solid 6.0X25mm Gen 3

PedFuse®

FDA UDI
SPINEFRONTIER, INC.·00190361014935·Screw Assy REset Solid 6.0X30mm Gen 3

PedFuse®

FDA UDI
SPINEFRONTIER, INC.·00190361014980·Screw Assy REset Solid 6.0X55mm Gen 3

PedFuse®

FDA UDI
SPINEFRONTIER, INC.·00190361014942·Screw Assy REset Solid 6.0X35mm Gen 3

PedFuse®

FDA UDI
SPINEFRONTIER, INC.·00190361014911·Screw Assy REset Solid 6.0X20mm Gen 3

PedFuse®

FDA UDI
SPINEFRONTIER, INC.·00190361014973·Screw Assy REset Solid 6.0X50mm Gen 3

MYSONO U5 DIAGNOSTIC ULTRASOUND SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

SYNAPSE 3D LIVER ANALYSIS

FDA 510(k)
FDA Class 2 ·Radiology

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·November 4, 2022

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·July 19, 2022

T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code OZO·November 15, 2019

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·July 13, 2022

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·July 11, 2025

COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

FDA Adverse Event
Malfunction ·BECKMAN COULTER INC.·Product code GKZ·July 27, 2011

HEART START XL

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 4, 2013

INTERSTIM

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO·Product code EZW·September 29, 2008

ARTHREX ANGEL SYSTEM WITH ASPIRATION KIT

FDA Adverse Event
Injury ·ARTHREX, INC.·Product code ORG·May 1, 2019