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LIASYS 450

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Millennium

FDA UDI
Avalign Technologies, Inc.·00190776172046·REICH-NECHTOW HYSTERECTOMY STR FCP

JOBST forMen Casual

FDA UDI
BSN MEDICAL, INC.·00035664131319·FOR MEN CASUAL 20-30 MM HG KNEE HIGH CLOSED TOE...

General Instrument

FDA UDI
Life Spine, Inc.·00190837089320·

BIOSCREW XTRALOK

FDA 510(k)
FDA Class 2 ·Orthopedic

LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC / E4D, LAVA ULTIMATE IMPLANT CROWN RESTORATIVE

FDA 510(k)
FDA Class 2 ·Dental

T:FLEX INSULIN DELIVERY SYSTEM

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code LZG·July 7, 2021

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·September 18, 2019

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·May 14, 2024

COBAS 6000 CORE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·July 16, 2008

AIR DERMATOME HANDPIECE

FDA Adverse Event
Malfunction ·ZIMMER SURGICAL·Product code GFD·May 9, 2013

NATURALYTE

FDA Adverse Event
Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 22, 2014

ASR UNI FEMORAL IMPL SIZE 51

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·May 20, 2011

UNKNOWN SCREW

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code PAO·February 4, 2015

UNK - BIOMATERIAL - CEMENT: VERTECEM V+

FDA Adverse Event
Malfunction ·SYNTHES GMBH·Product code NDN·May 5, 2025

TOSOH ST AIA 25-OH VITAMIN D PRETREATMENT SET

FDA Adverse Event
Malfunction ·TOSOH CORPORATION·Product code MRG·April 19, 2018

AXIUM

FDA Adverse Event
Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code HCG·December 5, 2022

EMBLEM S-ICD Model A209

FDA Enforcement
Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

Model Number L231, PROPONENT DR EL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025