BEUDAMED
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    SOLUS ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SPINAL SPACER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    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

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814657·GENUMEDI SILVER SIZE II

    JOBST Bella Strong

    FDA UDI
    BSN MEDICAL, INC.·00035664010461·BELLA STRONG 30-40 MM HG ARMSLEEVE KNIT WELT SI...

    ILIZAROV SYSTEMS

    FDA UDI
    MEDICALPLASTIC SRL·28033201841901·THREADED ROD SLOTTED 80MM LENGTH

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776373481·Weber Aortic Clamp, curved right, 26cm

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113424·CRESCENT KNIFE BEVEL UP (BX/5)

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383502214·Gutta Percha Points is used to root canal filin...

    L1 MANDIBLE

    FDA UDI
    KLS-Martin L.P.·00888118142207·LID, PLATE, FRACTURE

    OMNI GRACE LATEX EXAMINATION GLOVE, POWDER FREE, POLYMER COATED WITH PROTEIN CLAIM

    FDA 510(k)
    FDA Class 1 ·General Hospital

    VAPR TC ELECTRODE FOR USE WITH VAPR II ELECTROSURGICAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NIAGARA® Lateral Access System

    FDA UDI
    VB Spine LLC·10888857517240·Posterior Blade, Size 90 mm

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 2, 2024

    VERCISE GENUS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code NHL·July 6, 2023

    ASR ACETABULAR IMPLANT 58

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·May 9, 2013

    PERCUTANEOUS THROMBOLYTIC DEVICE KIT

    FDA Adverse Event
    Malfunction ·ARROW INTERNACIONAL INC.·Product code MCW·August 27, 2014

    2800

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

    SYRINGE FLU PLUS 0.1-1ML VAR DOSE 23X1

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·April 28, 2021

    STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System. Model P6500, 510 (k) Numbers: K090036 Cleared 4/05/2010; K101409 cleared 8/2/2010; K102462, cleared 9/2/2010; add to file 2/24/2011. The SYSTEM 1E Liquid Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reuseable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.

    FDA Recall
    Terminated ·Steris Corporation Hopkins Facility·Product code MED·December 7, 2011

    I.T.S. DUL (Distal Ulna Locking) System and UOL (Ulna Osteotomy Locking) System with the below descriptions and corresponding article numbers. 1. I.T.S. DUL (Distal Ulna Locking) System, Distal Ulna Plate; Article Numbers: 21232-3, 21232-4, 21232-6, 21233-3, 21233-4, 21233-6, 21234-4, 21235-4. 2. I.T.S. UOL (Ulna Osteotomy Locking) System, Ulna Osteotomy Plate; Article Numbers: 21231-6. 3. UOL (Ulna Osteotomy Locking) System, Cancellous Screw, Locking; Article Numbers: 37302-18, 37302-20.

    FDA Enforcement
    Class II ·Ongoing·I.T.S. GmbH·April 1, 2026