BEUDAMED
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    REPROCESSED ATHROSCOPICS BURS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·00304040133064·Zirlux TR OM2 98x18mm

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00126051·

    n/a

    FDA UDI
    Ortho Development Corporation·00822409072743·Narrow Fully Toothed Broach Size 5

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450281796·

    COLOR SPEX

    FDA UDI
    FGX INTERNATIONAL INC.·00193033426708·

    MEDTRONIC EXTENDED

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·August 1, 2025

    MEDTRONIC EXTENDED

    FDA Adverse Event
    Injury ·UNOMEDICAL A/S·Product code FPA·September 9, 2025

    OMNIFIT SERIES I ACET. INSERT 10 26MM ID

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS MAHWAH·Product code JDI·May 8, 2012

    ATLAST DATA MANAGEMENT SOFTWARE (DMS)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    4.0/2.5 MM SELF-DRILLING SCHANZ SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    0009613348-2024-012605

    FDA Adverse Event
    Injury ·INSTITUT STRAUMANN AG·Product code DZE·September 23, 2024

    0009613348-2024-012605

    FDA Adverse Event
    Injury ·INSTITUT STRAUMANN AG·Product code DZE·September 23, 2024

    ASR ACETABULAR IMPLANT 48

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·March 20, 2013

    ASR ACETABULAR CUPS 56

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·February 24, 2011

    OBTAPE SLING

    FDA Adverse Event
    Injury ·MENTOR·Product code FTL·March 10, 2008

    Ulnar Shorting Saw Blade is labeled in part: "Congruent Bone Plates, SIZE Ulnar Shortening Saw Blade - Hub Style S, REF 80-0499-S, Material: Stainless Steel, STERILE, Rx Only, ACUMED, Hillsboro, OR, USA". The Ulnar Saw Blade is an accessory used with a Congruent Bone Plate System covered under K012655, but it is labeled and sold separately by itself. The saw blade is also sold as part of the Upper Extremity Osteotomy System (BOM 15-0030). The BOM 15-0030 system does not have a label, but the saw blade is individually labeled and shipped together with this system when it is ordered. Intended use: Cutting Bones

    FDA Recall
    Terminated ·Acumed LLC·Product code HRS·April 14, 2010

    Curity Adult Lumbar Puncture Tray with Safety Components 20G x 3.5 inch Product Code: 1032

    FDA Recall
    Terminated ·Kendall Healthcare Products Co·Product code FMI·October 8, 2004

    Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·October 2, 2019

    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018