BEUDAMED
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    SAM CHEST SEAL WITH VAVLE; SAM CHEST SEAL

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814664·GENUMEDI SILVER SIZE III

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814541·GENUMEDI SAND SIZE III

    N/A

    FDA UDI
    GEORGE TIEMANN & CO.·B58211024030·

    JOBST Bella Strong

    FDA UDI
    BSN MEDICAL, INC.·00035664010478·BELLA STRONG 30-40 MM HG ARMSLEEVE KNIT WELT SI...

    ILIZAROV SYSTEMS

    FDA UDI
    MEDICALPLASTIC SRL·28033201841918·THREADED ROD SLOTTED 100MM LENGTH

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383502221·Gutta Percha Points is used to root canal filin...

    VANGUARD REPROCESSED COMPRESSION GARMENT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NOVOFINE 31 DISPOSABLE NEEDLE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NIAGARA® Lateral Access System

    FDA UDI
    VB Spine LLC·10888857517257·Posterior Blade, Size 100 mm

    LASSO 2515 NAV VARIABLE CATHETER

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code DRF·May 9, 2013

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 20, 2011

    GALILEO

    FDA Adverse Event
    Malfunction ·IMMUCOR, INC.·Product code KSZ·August 11, 2008

    Integra Large Rickham -Style Reservoir Rx Only Sterile for Single Use Only Integra NeuroSciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Made in the USA NL 850-1132 Provides access to the lateral cerebral ventricles via hypodermic puncture. It is useful in obtaining CSF (cerebral spinal fluid_ samples for cytological and chemical studies, for monitoring ventricular fluid pressure and for ventricular drainage. The reservoir provides easy access to the lateral ventricles and to cystic tumors for the injections of chemotherapeutic agents and/or radio-isotopes. The rickham reservoir may be utilized in hydrocephalic patients as a component in systems designed to shunt CSF from the lateral ventricles into either the right atrium of the heart of the peritoneum.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·January 15, 2014

    Catalog SBA35GSMOG, Sterile General Surgery Pack, Mfg date 5/21/03, order 101467;

    FDA Recall
    Terminated ·Cardinal Health·Product code LRO·June 27, 2003

    SOLUS Anterior Lumbar Interbody Fusion Spinal Spacer System, Solus Proximal/Distal Deployment Wrenches, 510(k) K102402. The Alphatec Solus Anterior Lumbar Interbody Fusion (AUF) System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DOD) at one or two contiguous levels from L2-S1 with up to Grade 1 spondyiolisthesis or retrolisthesis at the involved level(s). DOD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The Alphatec Solus implant is intended to be used with autograft. The device is intended for use with supplemental fixation that is in addition to the integrated blades. The Alphatec Solus implant is intended for use with supplemental spinal fixation. Specifically, the Alphatec Solus implant is to be used with the Alphatec's Zodiac Spinal Fixation System, Aspida" Anterior Lumbar Plating System, or the ILLlCO MIS Posterior Fixation System. Intervertebral body fusion device.

    FDA Recall
    Terminated ·Alphatec Spine, Inc.·Product code MAX·March 19, 2012