BEUDAMED
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    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526743458·LEVAMED ANKLE SUPPORT SILVER I

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0102110·Shaver, Open 11mm

    neoWave LS

    FDA UDI
    XENIX MEDICAL LLC·00818345023949·PADDLE SPREADER, 11MM

    STERILE NITRILE POWDER-FREE EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    VENTRIO

    FDA UDI
    Davol Inc.·00801741016387·Ventrio Hernia Patch, 8 cm x 12 cm (3.1" x 4.7"...

    PRINCETON

    FDA UDI
    Princeton Medical Group, Inc.·00810158213319·SCISSOR WESTCOTT OPHTHALMIC SHARP CURVED FLAT H...

    Soft-Form™ AL External Nasal Splint

    FDA UDI
    INVOTEC INTERNATIONAL, INC.·00818501022571·Soft-Form™ AL External Nasal Splint, Regular

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0120110·Assembly, Screwdriver, Polyaxial, Cannulated, L...

    MODIFICATION TO INTRALASE 600C LASER KERATOME

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

    BUILD-IT FR

    FDA 510(k)
    FDA Class 2 ·Dental

    IV SET TUR Y-TUBE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FPA·March 29, 2021

    BRILIANCE BIG BORE

    FDA Adverse Event
    PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.·Product code JAK·March 14, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·February 11, 2011

    POLYFLUX LR CAPILLARY DIALYZER

    FDA Adverse Event
    Malfunction ·GAMBRO DIAYLZATOREN GMBH·Product code MSF·March 10, 2008

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    FDA Adverse Event
    Injury ·ALLERGAN·Product code LTI·May 5, 2010

    VENTRIO MESH

    FDA Adverse Event
    Injury ·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·February 22, 2018

    VENTRIO MESH

    FDA Adverse Event
    Injury ·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·January 10, 2018

    BARD Ventrio Small Oval Hernia Patch 3.1" x 4.7" Product Code: 0010211 Indicated for use in the reconstruction of soft tissue deficiencies such as for the repair of hernias.

    FDA Recall
    Terminated ·Davol, Inc., Sub. C. R. Bard, Inc.·Product code FTL·October 15, 2010

    Bard Ventrio Small Oval Hernia Patch 8cm X 12cm (3.1" x 4.7"), Warwick, RI Product Code: 0010211 The Ventrio Hernia Patch is a self-expanding non-absorbable, sterile prosthesis, containing two primary layers of monofilament polypropylene mesh stitched with PTFE monofilament to an ePTFE sheet, forming a positioning pocket. The Ventrio Hernia Patch is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias.

    FDA Recall
    Terminated ·Davol, Inc., Sub. C. R. Bard, Inc.·Product code FTL·April 8, 2010

    Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue.

    FDA Enforcement
    Class II ·Terminated·Instrumed International, Inc.·October 8, 2014