BEUDAMED
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    SAFESTEP MAX POWER-INJECTABLE INFUSION SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Portable LED Light Source

    FDA UDI
    COGENTIX MEDICAL, INC.·00874485000318·

    Matira

    FDA UDI
    Kalitec Direct LLC·B073K0730000·Plate Bender, Universal

    CRYOSURGICAL UNIT AND ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·November 6, 2024

    WAVEWRITER ALPHA

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 21, 2023

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 27, 2025

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·April 23, 2013

    TREATMENT RECLINER

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FRK·April 21, 2011

    INTEGRITY SR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·July 11, 2008

    BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·October 8, 2024

    COMPREHENSIVE REVERSE MINI BASEPLATE & TAPER ADAPTOR

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWS·October 25, 2018

    COMPREHENSIVE REVERSE COBALT CHROME STANDARD HUMERAL TRAY 44MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWS·October 25, 2018

    COMPREHENSIVE PRIMARY HUMERAL STEM¿MINI 11MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code MBF·October 25, 2018

    COMPREHENSIVE REVERSE VERSA-DIAL GLENOSPHERE STANDARD

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PAO·October 25, 2018

    BLS-100 LED LIGHT SOURCE / BLS-1000 PORTABLE

    FDA Adverse Event
    Malfunction ·VISION-SCIENCES, INC.·Product code EOB·June 20, 2014

    BIOMET StageOne, Shoulder Cement Spacer Mold 10 MM, 50 X 21 X 57 MM, Silicone, Sterile, Item 431410.

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

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024