131 results · 24ms · Sources: EU EUDAMED, US FDA

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Durepair Dura Regeneration Matrix

FDA 510(k)
FDA Class 2 ·Neurology

ODALYS PEDICLE SCREW SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

CARDIQ FUSION

FDA 510(k)
FDA Class 2 ·Radiology

APPLICAT OUT SHAFT

FDA Adverse Event
Malfunction ·SYNTHES HAGENDORF·Product code MAX·June 26, 2017

GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·November 15, 2018

BD LUER-LOK¿ SYRINGE WITH DETACHABLE BD ECLIPSE¿ NEEDLE

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMI·January 19, 2022

BD ECLIPSE¿ BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMI·January 6, 2022

BD ECLIPSE¿ NEEDLE

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMI·January 27, 2022

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 13, 2011

XMAX MOTOR

FDA Adverse Event
Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code ERL·June 11, 2013

PROLIEVE THERMODILITATION KIT

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code MEQ·September 12, 2008

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·June 24, 2025

GMK PRIMARY TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·February 27, 2025

BD SYRINGE¿ 3ML LL W/NDL ECLIPSE¿ 22X1 RB

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMI·March 29, 2019

BD SYRINGE 3ML LL W/NDL ECLIPSE 22X1 RB

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMI·June 25, 2019

BD ECLIPSE BD LUER-LOK SYRINGE WITH DETACHABLE NEEDLE

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMF·May 10, 2019

SYRINGE 3ML LL W/NDL ECLIPSE 22X1 RB

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMI·March 26, 2019

BD LUER -LOK¿ SYRINGE WITH DETACHABLE NEEDLE

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMI·September 19, 2018

Jackson-Pratt Silicone Round Drain, 10FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use

FDA Enforcement
Class II ·Terminated·Cardinal Health 200, LLC·May 31, 2017

22 G X 1 1/2 IN. BD ECLIPSE¿ 3 ML BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMI·July 13, 2018