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