16 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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