BEUDAMED
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    SOFT SACK IV FLUID WARMER, THE FLOORMOUNT IV FLUID WARMER, THE PAK 2 IV WARMER AND THE THERMAL SAC PRESSURE INFUSER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HARRISON HAND HELD ADJUSTING INSTRUMENT

    FDA 510(k)
    FDA Unclassified ·Unknown

    PSYCHEMEDICS ANALYSIS OF MORPHINE IN HAIR

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    TX ACCUNET EMBOLIC PROTECTION SYSTEM

    FDA Adverse Event
    Malfunction ·GUIDANT ENDOVASCULAR SOLUTIONS·Product code NFA·December 6, 2006

    ACS HI-TORQUE BALANCE HEAVYWEIGHT GUIDE WIRE WITH HYD

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-CARDIAC THERAPIES-P.R.·Product code DQX·August 20, 2010

    KAINOX SL 75/16

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code NVY·April 16, 2013

    PROGRAMMABLE VALVE, RT ANGLE W/SIPHONGUARD

    FDA Adverse Event
    Malfunction ·CODMAN AND SHURTLEFF, INC. MEDOS S.A.·Product code JXG·March 11, 2011

    ANCHOR

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, NEUROMODULATION·Product code GZB·August 6, 2014

    Applied Medical's Inzii 12/15mm Retrieval System. Applieds Inzii Tissue Retrieval Bag, Model Number CD004, is classified as a Class II device. It was cleared to market via 510(k) filing K060051. The retrieval bag is a disposable specimen retrieval bag intended for use as receptacle for the collection of tissue, organs, and calculi during laparoscopic procedures. Applieds CD004 has a shelf life of three years. It is provided sterile and packaged in a heat sealed Tyvek pouch.

    FDA Recall
    Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa # 3 Rancho Santa·Product code GCJ·October 21, 2013

    Applied Medical's Inzii¿ 12/15mm Retrieval System. Applieds Inzii Tissue Retrieval Bag, Model Number CD004, is classified as a Class II device. It was cleared to market via 510(k) filing K060051. The retrieval bag is a disposable specimen retrieval bag intended for use as receptacle for the collection of tissue, organs, and calculi during laparoscopic procedures. Applieds CD004 has a shelf life of three years. It is provided sterile and packaged in a heat sealed Tyvek pouch.

    FDA Enforcement
    Class II ·Terminated·Applied Medical Resources Corp·November 20, 2013

    Contour¿ next GEN Blood Glucose Monitoring System

    FDA Enforcement
    Class II ·Ongoing·Ascensia Diabetes Care US, Inc.·July 26, 2023

    OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX; c. OPTETRAK Logic CR Tibial Inserts, Product Line 02-012-47-XXXX; d. OPTETRAK Logic CR Slope + Tibial Inserts, Product Line 02-012-48-XXXX; e. OPTETRAK Logic CR Slope ++ Tibial Inserts, Product Line 02-012-49-XXXX; f. OPTETRAK Logic CRC Tibial Inserts, Product Line 02-012-51-XXXX; g. OPTETRAK Logic CC Tibial Inserts, Product Line 02-012-65-XXXX; Affected 510(k) numbers include: K033883, K132161, K093360, K110547, K111400, K121307, K123342, K150890. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024