BEUDAMED
    20 results · 35ms · Sources: EU EUDAMED, US FDA

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    ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY

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

    Pro-Link Ti

    FDA UDI
    Life Spine, Inc.·00190837080655·

    EXODUS DRAINAGE CATHETER

    FDA Adverse Event
    Malfunction ·ANGIODYNAMICS·Product code FGE·February 17, 2022

    EXODUS DRAINAGE CATHETER

    FDA Adverse Event
    Malfunction ·ANGIODYNAMICS·Product code FGE·February 17, 2022

    ALEUTIAN® Interbody Systems

    FDA UDI
    VB Spine LLC·10888857561649·Trial Size 12x14x9 mm, 7 Deg.

    SKYLIGHT IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    MISTRAL-AIR WARMING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code LWS·October 1, 2014

    GENESYS HTA PROCERVA®

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code MNB·May 29, 2013

    REVEAL XT

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL, INC.·Product code DSI·June 16, 2011

    LASSO® 2515 NAV ECO VARIABLE CATHETER

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code DRF·October 2, 2012

    LASSO 2515 NAV VARIABLE CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER, INC (IRWINDALE)·Product code DRF·July 5, 2011

    STOCKERT EP-SHUTTLE RADIO FREQUENCY GENERATOR

    FDA Adverse Event
    Malfunction ·STOCKERT GMBH·Product code DRF·August 18, 2011

    EZ Derm Porcine Xenograft, labeled as the following: a. EZ Derm 3x4 (8x10 cm) Non-Perforated, Part Number: 131703-03; b. EZ Derm 7 x 18 (17 x 46 cm) Non-Perforated, Part Number: 131704-03; c. EZ Derm 2 x 2 (5 x 5 cm) Non-Perforated, Part Number: 131705-03; d. EZ Derm 3 x 48 (8 x 122 cm) Perforated, Part Number: 131710-03; e. EZ Derm 3 x 24 (8 x 61 cm) Perforated, Part Number: 131711-03; f. EZ Derm 3 x 12 (8 x 30 cm) Perforated, Part Number: 131712-03; g. EZ Derm 3 x 4 (8 x 10 cm) Perforated, Part Number: 131713-03; h. EZ Derm 7 x 18 (17 x 46 cm) Perforated, Part Number: 131714-03; i. EZ Derm 2 x 2 (5 x 5 cm) Perforated. Part Number: 131715-03 Product Usage: EZ Derm is a porcine derived xenograft in which the collagen has been cross linked with an aldehyde. EZ Derm (porcine xenograft) can be used for partial thickness skin loss injuries. Use of EZ Derm for burns, donor sites and chronic vascular ulcers reduces pain and fluid loss. EZ Derm can also be used as a temporary cover, or test graft, prior to auto grafting and as a protective covering over perforated auto grafts.

    FDA Enforcement
    Class II ·Terminated·Molnlycke Health Care, Inc·May 8, 2019

    CARTO® 3 SYSTEM

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL)·Product code DQK·May 1, 2013

    LASSO® 2515 NAV ECO VARIABLE CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code DRF·December 2, 2013

    THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code LPB·October 18, 2013

    THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER, INC (IRWINDALE)·Product code LPB·October 9, 2013

    Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 3, 15.0 mm; Ref 97-0353.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code JWH·May 26, 2005

    EZ Derm Porcine Xenograft, labeled as the following: a. EZ Derm 3x4 (8x10 cm) Non-Perforated, Part Number: 131703-03; b. EZ Derm 7 x 18 (17 x 46 cm) Non-Perforated, Part Number: 131704-03; c. EZ Derm 2 x 2 (5 x 5 cm) Non-Perforated, Part Number: 131705-03; d. EZ Derm 3 x 48 (8 x 122 cm) Perforated, Part Number: 131710-03; e. EZ Derm 3 x 24 (8 x 61 cm) Perforated, Part Number: 131711-03; f. EZ Derm 3 x 12 (8 x 30 cm) Perforated, Part Number: 131712-03; g. EZ Derm 3 x 4 (8 x 10 cm) Perforated, Part Number: 131713-03; h. EZ Derm 7 x 18 (17 x 46 cm) Perforated, Part Number: 131714-03; i. EZ Derm 2 x 2 (5 x 5 cm) Perforated. Part Number: 131715-03 Product Usage: EZ Derm is a porcine derived xenograft in which the collagen has been cross linked with an aldehyde. EZ Derm (porcine xenograft) can be used for partial thickness skin loss injuries. Use of EZ Derm for burns, donor sites and chronic vascular ulcers reduces pain and fluid loss. EZ Derm can also be used as a temporary cover, or test graft, prior to auto grafting and as a protective covering over perforated auto grafts.

    FDA Recall
    Terminated ·Molnlycke Health Care, Inc·Product code KGN·March 26, 2019