14 results · 37ms · Sources: EU EUDAMED, US FDA

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EQUAFLOW MULTIVALVE INFUSION CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

SBH

FDA UDI
SBH Surgical·00850068304011·1/1, Sterilization Container Perforated Lid, Bl...

ArgenPMMA 98x30-A3.5

FDA UDI
ARGEN CORPORATION, THE·D818123235·Crown And Bridge, Temporary, Resin

UniTip High Resolution Catheter

FDA UDI
Unisensor AG·07640172970577·

MULTIPLE PRIVATE LABELS VINYL EXAMINATION GLOVES, POWDER-FREE

FDA 510(k)
FDA Class 1 ·General Hospital

ERBEFLO 2 DISPOSABLE TUBING SYSTEM

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

MONOPLUS VIOLET 1(4)150CM HRC40S LOOP(M)

FDA Adverse Event
Malfunction ·B. BRAUN SURGICAL, S.A.·Product code NEW·April 5, 2024

SMR SHOULDER

FDA Adverse Event
Injury ·LIMACORPORATE S.P.A.·Product code PHX·November 10, 2025

POWERED WHEELCHAIR

FDA Adverse Event
Malfunction ·INVACARE TAYLOR STREET·Product code ITI·May 21, 2013

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 26, 2014

INSYNC III MARQUIS

FDA Adverse Event
Injury ·MEDTRONIC S.A.·Product code NIK·June 14, 2011

Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)

FDA Enforcement
Class II ·Ongoing·Medtronic Inc.·November 29, 2017

Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

FDA Enforcement
Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012

Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

FDA Enforcement
Class II ·Terminated·Philips North America, LLC·March 25, 2020