BEUDAMED
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    Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging System

    FDA 510(k)
    FDA Class 2 ·Radiology

    Bendini

    FDA UDI
    Nuvasive, Inc.·00887517672261·Bendini Pointer, OCT Hybrid

    Kompressor™ Compression Screw System

    FDA UDI
    Ascension Orthopedics, Inc.·10381780065739·The mini Kompressor Compression Screw is a two-...

    PMT CORPORATION - STEREOTACTIC

    FDA UDI
    PMT CORPORATION·00650551039037·DEPTHALON ANCHOR BOLT CAP, FOR 2103-19-XX AND 2...

    Graseby

    FDA UDI
    ICU MEDICAL, INC.·00610586100195·

    PRIMA OXYGEN MONITOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    EXCELLAGEN

    FDA 510(k)
    FDA Unclassified ·Unknown

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAL

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 7, 2018

    0210-312-000-Woundcare Replacement kit with soft tip; 0210-318-000; Woundcare Replacement with fan tip; 0210-318-100- Woundcare Replacement Kit; 0210-318-200-Woundcare Replacement with retract coax tip. Accessory to Stryker InterPulse Irrigation System, used for wound debridement, soft tissue debridement, and cleansing of medical, clinical, or surgical sites.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code FQH·May 8, 2015

    0210-312-000-Woundcare Replacement kit with soft tip; 0210-318-000; Woundcare Replacement with fan tip; 0210-318-100- Woundcare Replacement Kit; 0210-318-200-Woundcare Replacement with retract coax tip. Accessory to Stryker InterPulse Irrigation System, used for wound debridement, soft tissue debridement, and cleansing of medical, clinical, or surgical sites.

    FDA Enforcement
    Class II ·Terminated·Stryker Instruments Div. of Stryker Corporation·July 22, 2015

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 13, 2014

    HOMECHOICE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - LARGO·Product code FKX·August 12, 2011

    EASYTRAK 2

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code OJX·July 8, 2013

    ORTHOPEDIC STEREOTAXIC INSTRUMENT

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code OLO·June 4, 2025

    BD BBL Sensi Disc Imipenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231644 and 231645¿

    FDA Enforcement
    Class II ·Ongoing·Becton Dickinson & Co.·February 14, 2024

    Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. 3 Model Numbers are used for this same Burette Administration Set described as 110 inch length/279 cm, 16.5ml priming volume, 20 drops/ml, 3 standard injection sites. Model Number I8C1230J (Reorder No. 21-0301-25) for product distributed to Japan. Model Number I8C1230 (Reorder No. (21-0318-25) for product distributed Internationally. Model Number 8C1230 (Reorder No. 21-0305-01) for product distributed within the United States.

    FDA Recall
    Terminated ·Smiths Medical MD, Inc.·Product code FPA·December 3, 2004

    -Outer Kit Box (P/N RFIT-LBL-0140) - FilmArray¿ Meningitis/Encephalitis (ME) Panel REF RFIT-ASY-0118 30 For FilmArray systems LOT KIT UDI (01)00815381020123 CE 0086 IVD -Fitment Label (P/N RFIT-LBL-0138) which identifies the pouch label - FilmArray¿ ME Panel v1.4 LOT SN CE 0086 IVD Product Usage: The FilmArray Meningitis/Encephalitis (ME) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray systems.

    FDA Enforcement
    Class II ·Terminated·BioFire Diagnostics, LLC·November 21, 2018

    ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·July 9, 2014

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 200 MM, Silicone, Sterile, Item 431195.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    BIOMET StageOne Hip Cement Spacer Mold with Insert, 56 MM, Silicone, Sterile, Item 431183.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020