28 results
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38ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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