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

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SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath

FDA 510(k)
FDA Class 2 ·Cardiovascular

BD BBL™ Sensi-Disc™ Gentamicin 10 µg

FDA UDI
BECTON, DICKINSON AND COMPANY·00382902312277·BD BBL™ Sensi-Disc™ Gentamicin 10 µg

OsteoMed

FDA UDI
OSTEOMED LLC·00845694021852·FPS 2.7mm Clearance Drill Bit

OsteoMed

FDA UDI
OSTEOMED LLC·00845694076487·FPS 2.7 Clearance Drill Bit Sterile Qty 2

PADSCAN HD SERIES BLADDER SCANNER

FDA 510(k)
FDA Class 2 ·Radiology

LORDEX POWER TRACTION EQUIPMENT

FDA 510(k)
FDA Class 2 ·Physical Medicine

ONE TOUCH ULTRA

FDA Adverse Event
Malfunction ·LIFESCAN, INC.·Product code CFR·October 8, 2003

NEEDLE,25GX1.5",REG,BEVEL

FDA Adverse Event
Injury ·MEDLINE INDUSTRIES LP·Product code FMI·December 13, 2024

RESTORE RECHARGEABLE NEUROSTIMULATOR

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·November 13, 2008

SECURE II MED/SURG BED

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code FNL·July 18, 2011

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·July 17, 2013

UNSPECIFIED BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE TUBES

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·October 15, 2025

BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE 5MG/4MG

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·May 23, 2024

CARTO 3

FDA Adverse Event
Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·September 16, 2024

CARTO® 3 SYSTEM

FDA Adverse Event
Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·May 21, 2024

CARTO 3

FDA Adverse Event
Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·October 28, 2025

CARTO® 3 SYSTEM

FDA Adverse Event
Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·April 17, 2024

CARTO 3

FDA Adverse Event
Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·October 15, 2025

PRODIGY AUTOCODE

FDA Adverse Event
Injury ·OK BIOTECH CO., LTD.·Product code NBW·October 18, 2019

Revogene, Catalog no. 610210. IVD test instrument

FDA Enforcement
Class II ·Ongoing·Meridian Bioscience Inc·August 3, 2022