28 results · 38ms · Sources: EU EUDAMED, US FDA

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XACT.CARDIAC & XPRESS.CARDIAC

FDA 510(k)
FDA Class 2 ·Radiology

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04051526743625·LEVAMED ANKLE SUPPORT SAND V

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04051526743748·ACHIMED ACHILLES SUPP SAND V

Neo-Tee T-Piece Resuscitator

FDA UDI
MERCURY ENTERPRISES, INC.·10641043508152·

AS/3 ANESTHESIA MONTIOR WITH S-ANE99(A)/L-ARK99(A)

FDA 510(k)
FDA Class 2 ·Cardiovascular

NTERO NOMAD SYSTEM

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

BD PHOENIX¿ SMIC-101

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·February 13, 2026

IBC Vascular Loop Catalog Number CH111, CH112, CH113, CH114, CH115, CH116, CH118 Product Usage: The IBC Vascular Loop is a single-use, disposable loop used in occluding, retracting, and identifying arteries, veins, tendons, and nerves in surgical procedures.

FDA Enforcement
Class II ·Terminated·International Biophysics Corp.·August 26, 2015

IBC Aortic Punch Catalog Numbers APM40, APL48A, APM44A, APL40A, APM40A, CVAPL36, CVAPL40, CVAPL44, CVAPL48, CVAPL52, APM28BM, APM36BM, APM40BM, APM44BM, APM48BM, APM40BK, APM48BK, APM36BK, APM44BK, APM28, APM36, APL44, APM40 Product Usage: The IBC Aortic Punch is a single-use, disposable surgical punch used to create an opening in the wall of the aorta to prepare a site for anastomosis.

FDA Enforcement
Class II ·Terminated·International Biophysics Corp.·August 26, 2015

UNKNOWN DEPUY 36MM +4 NEUTRAL CROSSLINKED POLYETHYLENE LINER

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code UJD·April 10, 2013

TITAN MODULAR TOTAL SHOULDER SYSTEM - BODY

FDA Adverse Event
Injury ·ASCENSION ORTHOPEDICS, INC.·Product code KWS·April 1, 2011

RIATA ST OPTIM ACTIVE-FIXATION

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·May 27, 2008

BD MULTI-CHECK CD4 LOW CONTROL

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·August 29, 2023

BD PHOENIX¿ SMIC/ID-101

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·October 16, 2024

BD PHOENIX¿ SMIC/ID-101

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·July 1, 2024

BD PHOENIX SMIC/ID-101

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code LON·May 6, 2021

BD PHOENIX¿ SMIC-101

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·July 28, 2025

BD PHOENIX¿ SMIC-101

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·July 28, 2025

BD PHOENIX¿ SMIC-101

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·July 28, 2025

BD PHOENIX¿ SMIC/ID-101

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·November 8, 2024