18 results · 24ms · Sources: EU EUDAMED, US FDA

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PROGRIP LAPARSCOPIC SELF-FIXATING MESH

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

ArgenPMMA 98x25-B4

FDA UDI
ARGEN CORPORATION, THE·D818120897·Crown And Bridge, Temporary, Resin

Hayden Medical

FDA UDI
Hayden Medical, Inc.·00840319720417·Green Tissue Forceps 4" (10cm), T-shape, 5mm wi...

ROSSMAX AUTOMATIC WRIST BLOOD PRESSURE MONITOR, MODELS B150 & Q400

FDA 510(k)
FDA Class 2 ·Cardiovascular

LEGION POROUS + HA TIBIAL BASEPLATES

FDA 510(k)
FDA Class 2 ·Orthopedic

STAT DL 9.5 FR. 40 CC. IAB

FDA Adverse Event
Malfunction ·DATASCOPE CORP.·Product code DSP·November 8, 1997

STAT DL 9.5 FR. 40 CC. IAB

FDA Adverse Event
Malfunction ·DATASCOPE CORP.·Product code DSP·November 8, 1997

BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

FDA Adverse Event
Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·October 24, 2018

COULTER® LH 780 HEMATOLOGY ANALYZER

FDA Adverse Event
Malfunction ·BECKMAN COULTER·Product code GKZ·May 20, 2013

SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·September 26, 2014

MINICAP

FDA Adverse Event
Injury ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·June 12, 2011

EAGLE EYE PLATINUM SHORT TIP

FDA Adverse Event
Injury ·VOLCANO CORPORATION·Product code OBJ·July 1, 2016

EAGLE EYE PLATINUM SHORT TIP; EAGLE EYE PLATINUM ST CATHETER

FDA Adverse Event
Injury ·VOLCANO CORPORATION·Product code OBJ·July 1, 2016

EAGLE EYE PLATINUM SHORT TIP; EAGLE EYE PLATINUM ST CATHETER

FDA Adverse Event
Injury ·VOLCANO CORPORATION·Product code OBJ·July 1, 2016

BD INSYTE AUTOGUARD CATETER I.V. 20G X 1.16

FDA Adverse Event
Malfunction ·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FOZ·October 20, 2020

INSYTE AUTOGUARD PNK 20GA X 1.16IN

FDA Adverse Event
Injury ·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FOZ·December 2, 2020

Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·October 13, 2021

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