16 results · 29ms · Sources: EU EUDAMED, US FDA

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GYNECOLOGY STERILIZATION TRAY

FDA 510(k)
FDA Class 2 ·General Hospital

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04049772813841·GENUMEDI PRO SILVER SIZE IV

RUSCH

FDA UDI
TELEFLEX INCORPORATED·14026704623881·Berman Airway 90mm ISO 9

Tasso+ Convenience Kit

FDA UDI
Tasso Inc.·00850038691042·

UniTip Catheter

FDA UDI
Unisensor AG·07640172973226·

MAEDA SILVER ACUPUNCTURE NEEDLE

FDA 510(k)
FDA Class 2 ·General Hospital

SMARTXIDE 50 HS/MS

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

NEPTUNE ROVER WITHOUT SMOKE EVAC AND POWER POLE

FDA Adverse Event
Injury ·STRYKER INSTRUMENTS-KALAMAZOO·Product code FYD·May 21, 2013

PINNACLE MTL INS NEUT36IDX52OD

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·June 9, 2011

PROXIMATE PPH PROCEDURE SET

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code GDW·August 13, 2008

INSPIRE 8F DUAL

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA·Product code DTN·January 9, 2026

INSPIRE 6 HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RES

FDA Adverse Event
SORIN GROUP ITALIA S.R.L.·Product code DTZ·December 7, 2016

SMARTXIDE 50 HS

FDA Adverse Event
Malfunction ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·October 30, 2023

ANGIOVAC

FDA Adverse Event
Malfunction ·ANGIODYNAMICS·Product code DWF·January 21, 2020

Cook brand Zenith rupture main body graft, preloaded graft measuring 26 mm diameter at promial end and 12 mm diameter at distal end, with the H&L-B One Shot Introducer System, non-sterile, export only for further processing; ZRB-26-WCE.

FDA Recall
Terminated ·Cook, Inc.·Product code MIH·June 10, 2004

Titan Pump - Product Usage: indicated for male patients suffering from erectile dysfunction (impotence) who are considered to be candidates for implantation of a penile prosthesis.

FDA Enforcement
Class II ·Terminated·Coloplast Manufacturing US, LLC·December 2, 2020