21 results · 22ms · Sources: EU EUDAMED, US FDA

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G Surgical Marksman MIS System

FDA 510(k)
FDA Class 2 ·Orthopedic

TALOS® HA PEEK IBF

FDA UDI
MEDITECH SPINE, LLC·B167321615160·

STAODYN MAX PRESET, MODEL 4470

FDA 510(k)
FDA Class 2 ·Neurology

NMR LIPOPROFILE (R) TEST AND NMR PROFILER

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

PENTA

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 5, 2013

TELIGEN

FDA Adverse Event
Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 14, 2011

FLO-GARD 6301 VOLUMETRIC INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·September 17, 2008

FLEXIBLE NEURO-FIBERSCOPE, 3.7MM X 34CM, Model # 11282BN1

FDA Enforcement
Class II ·Terminated·Karl Storz Endoscopy·September 4, 2019

THREE PEG PATELLA 41MM

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·February 4, 2025

BD NANO¿ PEN NEEDLE

FDA Adverse Event
Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·March 4, 2019

BD NANO¿ 2ND GEN PEN NEEDLE

FDA Adverse Event
Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·February 7, 2022

Jackson-Pratt Silicone Flat Drain, 10mm Full W/Trocar. 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

BD ULTRA FINE PEN NEEDLES

FDA Adverse Event
Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·September 11, 2020

LOGIC CR TIB INSERT STD, SZ 5, 9MM

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·August 31, 2023

PEN NDL 32G 4MM 5B XTW BULK US W/EXPIRY

FDA Adverse Event
Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·April 13, 2020

BD ULTRA-FINE¿ MINI PEN NEEDLE

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code FMI·February 5, 2019

BD¿ ULTRA-FINE PEN NEEDLES

FDA Adverse Event
Injury ·BECTON DICKINSON AND CO.·Product code FMI·January 24, 2019

RELION PEN NEEDLE

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code FMI·March 25, 2021

BD ULTRA FINE¿ SHORT INSULIN PEN NEEDLE

FDA Adverse Event
Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·March 27, 2018

6MM X 32G PEN NEEDLE (ULTRAFINE MICRO)

FDA Adverse Event
Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·March 11, 2021