20 results · 23ms · Sources: EU EUDAMED, US FDA

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Turbo-Power (2.0mm) Laser Atherectomy Catheters

FDA 510(k)
FDA Class 2 ·Cardiovascular

Bowman Lacrimal Probe

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896114272·Bowman Lacrimal Probe Size 4/5 Butterfly Handle...

ORTHODONTIC CERAMIC BRACKET

FDA 510(k)
FDA Class 2 ·Dental

NUVASIVE COROENT NO-PROFILE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

FRESENIUS 2008K

FDA Adverse Event
Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·October 7, 2014

COGNIS

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

GYNECARE PROLIFT TOTAL PELVIC FLOOR REPAIR SYSTEM

FDA Adverse Event
Injury ·ETHICON INC.·Product code OTP·June 11, 2013

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

BD ULTRA FINE PEN NEEDLES

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

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

PEDICLE SCREW LATERAL CONNECTOR L150

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code NKB·December 13, 2023

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

BD ULTRA FINE¿ PEN NEEDLES

FDA Adverse Event
Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·March 18, 2019

R-F IM NAIL 10MMDX48CM LG, 11MMDX42CM, 11MMDX44CM, 11MMDX46CM LG, 11MMDX48CM LG, 12MMDX46CM LG, 12MMDX48CM LG, 13MMDX40CM, 13MMDX42CM, 13MMDX44CM, 13MMDX46CM LG, 13MMDX48CM LG, 14MMDX34CM, 14MMDX36CM, 14MMDX38CM, 14MMDX40CM, 14MMDX42CM, 14MMDX44CM, 14MMDX46CM LG, 14MMDX48CM LG

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·June 21, 2017

RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.

FDA Enforcement
Class II ·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014