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

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

SAS STREPALERT

FDA 510(k)
FDA Class 1 ·Microbiology

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450512517·

STEVE MADDEN

FDA UDI
FGX INTERNATIONAL INC.·00193033483015·

INSET

FDA Adverse Event
Injury ·UNOMEDICAL UM-D·Product code FPA·February 9, 2026

INSET

FDA Adverse Event
Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·January 22, 2026

INSET

FDA Adverse Event
Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·January 22, 2026

INSET

FDA Adverse Event
Injury ·UNOMEDICAL UM-D·Product code FPA·February 9, 2026

INSET

FDA Adverse Event
Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·January 22, 2026

INSET

FDA Adverse Event
Injury ·UNOMEDICAL UM-D·Product code FPA·February 9, 2026

V-40/C-TAPER ADAPTER SLEEVE

FDA 510(k)
FDA Class 2 ·Orthopedic

IL TEST FREE PROTEIN S

FDA 510(k)
FDA Class 2 ·Hematology

ASR ACETABULAR IMPLANT 60

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL·Product code KWA·March 20, 2013

NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

FDA Adverse Event
Malfunction ·COCHLEAR LTD.·Product code MCM·March 10, 2011

SPRINT FIDELIS

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·March 10, 2008

BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·August 8, 2022

UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic

FDA Enforcement
Class II ·Ongoing·B-K Medical A/S·November 12, 2025

Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022

Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

FDA Enforcement
Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014