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bYomed Surgical MatriX

FDA UDI
Biogennix, LLC·00812593021726·

TEM/COM (DISTRIBUTED BY O/METER)

FDA Adverse Event
Injury ·TEM COM·Product code FLK·February 5, 2001

Scleral buckling device, non-bioabsorbable

FDA UDI
FCI S A S FCI 20 22·03760087122145·A sterile, non-bioabsorbable device intended to...

O-ARM IMAGING SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC NAVIGATION, INC (LITTLETON)·Product code OXO·November 23, 2021

STEALTHSTATION¿ S8 SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·December 19, 2022

STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC NAVIGATION, INC.·Product code HAW·June 5, 2014

TUNNELING TOOL WITH EXTENSION CARRIER

FDA Adverse Event
Malfunction ·MEDTRONIC, INC·Product code HAO·March 20, 2015

IMPLANTABLE NEUROSTIMULATOR EXTENSION PASSER ACCESSORY KIT

FDA Adverse Event
Injury ·MEDTRONIC NEUROMODULATION·Product code LGW·July 8, 2015

STEALTHSTATION S7 SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC NAVIGATION, INC. (LOUISVILLE)·Product code HAW·May 24, 2017

SMARTLIFE SMALL ASPTC HOUSING

FDA Adverse Event
Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code HWE·July 28, 2016

RESERVOIR 3ML MMT-332A

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·May 9, 2018

2.5 mm Reaming Rod, Ball tip, 950 mm, sterile, Part Number: 351.706S Reaming Rods are intended for guiding of reamers during orthopedic surgery.

FDA Recall
Terminated ·Synthes (USA) Products LLC·Product code HTO·July 26, 2017

3.0 mm Reaming Rod, with straight ball tip, 950 mm, sterile, Part Number: 351.76S Reaming Rods are intended for guiding of reamers during orthopedic surgery.

FDA Recall
Terminated ·Synthes (USA) Products LLC·Product code HTO·July 26, 2017

2.5 mm Reaming Rod, Ball tip with extension, 950 mm, sterile, Part Number: 351.707S Reaming Rods are intended for guiding of reamers during orthopedic surgery.

FDA Recall
Terminated ·Synthes (USA) Products LLC·Product code HTO·July 26, 2017

2.5 mm Guide Rod, with smooth tip, 950 mm, sterile, Part Number: 355.042S Reaming Rods are intended for guiding of reamers during orthopedic surgery.

FDA Recall
Terminated ·Synthes (USA) Products LLC·Product code HTO·July 26, 2017

Light Clip for Oracle Retractor, sterile, Part Number: 03.809.925S Reaming Rods are intended for guiding of reamers during orthopedic surgery.

FDA Recall
Terminated ·Synthes (USA) Products LLC·Product code HTO·July 26, 2017

2.5 mm Titanium Calibrated Reaming Rod, 850 mm, Part Number: 359.083S Reaming Rods are intended for guiding of reamers during orthopedic surgery.

FDA Recall
Terminated ·Synthes (USA) Products LLC·Product code HTO·July 26, 2017

2.5 mm Reaming Rod, Ball tip, 1150 mm, sterile, Part Number: 351.708S Reaming Rods are intended for guiding of reamers during orthopedic surgery.

FDA Recall
Terminated ·Synthes (USA) Products LLC·Product code HTO·July 26, 2017

FLOW-I

FDA Adverse Event
Malfunction ·MAQUET CRITICAL CARE AB·Product code BSZ·March 1, 2023

Stem Extractor f/Guide Bar, Part number 03.401.072. Instrumentation for extraction and revision of Epoca shoulder implants.

FDA Recall
Terminated ·Synthes, Inc.·Product code HWB·March 19, 2018