BEUDAMED
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    HEARTSTART MRX, MODEL M3535A

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    Premier

    FDA UDI
    PREMIER DENTAL PRODUCTS COMPANY·D6911040404·CUBE PESSARY W/ DRAINAGE HOLES #4

    SW

    FDA UDI
    SW SAFETY SOLUTIONS INC.·00616489004042·PowerChem Neoprene Exam Gloves, Large

    Myo/Wire II

    FDA UDI
    A & E MEDICAL CORPORATION·10841291102120·SS Suture, 1 per sleeve

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450052839·

    Procellera Power Pack

    FDA UDI
    ARTHREX, INC.·00810198030426·Procellera Power Pack, 4"x4" Single Layer, 4"x4...

    EXEL I.V. ADMINISTRATION SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PC ECG 1200

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACCU-CHEK SPIRIT COMBO

    FDA Adverse Event
    Malfunction ·ROCHE DIABETES CARE AG·Product code LZG·April 8, 2013

    PROFEMUR(R) Z STEM PLASMA SPRAYED

    FDA Adverse Event
    Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code LPH·April 5, 2011

    ANALYTICAL D MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS CORP.·Product code JJE·May 7, 2008

    Greiner bio-one, VACUETTE TUBE, 9NC Coagulation Citrate 3.2%, 3.5ml blue cap-black ring, 24 racks of 50, 1200 pcs in total, non ridged, sandwich tube, Ref: 454332, Lot B040404, Expiry 2005-04, Sterile.

    FDA Recall
    Terminated ·Greiner VACUETTE North America·Product code GIM·July 27, 2004

    Philips and Laerdal brands of HeartStart HS1 Defibrillator Family Model number M5066A, M5067A, and M5068A Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA. The HS1 Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The HS1 uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems North America Co. Phillips·January 16, 2013

    PKG, 3MM INSERT, DORSEY GRASPER, 29CM, P/N 0250282097 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    Depuy brand ACE trochanteric nail; sterile, long, left hip, 420 x 13 x 130; Product 925213420.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code HSB·December 11, 2003

    SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·January 28, 2026

    Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

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