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Goodlife AC-300 Blood Glucose Monitoring System, Goodlife AC-301 Blood Glucose Monitoring System, Goodlife AC-302 Blood Glucose Monitoring System, Goodlife AC 303 Blood Glucose Monitoring System, Goodlife AC-304 Blood Glucose Monitoring System Goodlife AC-305 Blood Glucose Monitoring System, Goodlife AC-300 Professional Blood Glucose Monitoring System, Goodlife AC-301 Professional Blood Glucose Monitoring System Goodlife AC-30

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

PIVOX™ Oblique Lateral Spinal System

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169654723·SCREW 2140150 LUMBAR BONE 5.5 X 50MM

OsteoMed

FDA UDI
OSTEOMED LLC·00845694003773·4 Hole Mandibular Fracture Compression Plate

Thermoflect

FDA UDI
Encompass Group, L.L.C.·30612899003928·THERMOFLECT JACKET, XS, 25EA ...

APEX Knee System

FDA UDI
Omni Life Science, Inc.·00841690117414·Modular Knee Stem Pilot 15mm x 100mm

Mariner Outrigger

FDA UDI
Seaspine Orthopedics Corporation·10889981161514·Z-Rod, Dia. 6.0mm, Co-Cr, 150mm

MODIFICATION TO MEDAMICUS FLOWGUARD PEELABLE INTRODUCER

FDA 510(k)
FDA Class 2 ·Cardiovascular

CERAMICS2IN1

FDA 510(k)
FDA Class 2 ·Dental

PASSEO-14 2/140/150

FDA Adverse Event
Malfunction ·BIOTRONIK AG, BUELACH, SWITZERLAND·Product code LIT·June 8, 2021

PASSEO-14 2/140/150

FDA Adverse Event
Malfunction ·BIOTRONIK AG, BUELACH, SWITZERLAND·Product code LIT·February 28, 2023

PASSEO-14 2.5/140/150

FDA Adverse Event
Malfunction ·BIOTRONIK AG, BUELACH, SWITZERLAND·Product code LIT·June 14, 2023

PASSEO-14 2.5/140/150

FDA Adverse Event
Malfunction ·BIOTRONIK AG, BUELACH, SWITZERLAND·Product code LIT·March 11, 2021

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·February 9, 2022

FINELINE II

FDA Adverse Event
Injury ·CPI - DEL CARIBE·Product code DTB·October 3, 2014

TRUERESULT

FDA Adverse Event
Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code NBW·May 29, 2013

SYNCHRON® SYSTEMS RHEUMATOID FACTOR (RF) REAGENT

FDA Adverse Event
Malfunction ·BECKMAN COULTER, INC.·Product code DHR·June 25, 2011

STERLING?

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LIT·September 9, 2025

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·August 14, 2023

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·February 22, 2023

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·November 23, 2022