BEUDAMED
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    MODIFICATION TO: GP GENERAL PURPOSE DRAINAGE CATHETER, MINI-PIG DRAINAGE CATHETER, NEPHROSTOMY CATHETER, BILIARY

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    SPIROXCARD DIAGNOSTIC SPIROMETER AND PULSE OXIMETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    POLYMER COATED LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    TSRH SPINAL FIXATION SYSTEM

    FDA Adverse Event
    Injury ·SOFAMOR DANEK MANUFACTURING·Product code JDN·June 4, 1999

    ITREL

    FDA Adverse Event
    Other ·MEDTRONIC INC.·Product code GZB·March 28, 2001

    PERRY

    FDA Adverse Event
    Other ·ANSELL PERRY·Product code KGO·March 20, 1998

    UNK

    FDA Adverse Event
    Other ·JOHNSON & JOHNSON MEDICAL, INC.·Product code KGO·April 3, 1998

    Peel-Away

    FDA UDI
    COOK INCORPORATED·00827002091245·Peel-Away Introducer Set

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·October 2, 2024

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·January 14, 2026

    URETEX SUPPORT PP KIT X1

    FDA Adverse Event
    Injury ·SOFRADIM PRODUCTION·Product code FTL·April 3, 2013

    UNKNOWN ZIMMER SHOULDER

    FDA Adverse Event
    Injury ·ZIMMER INC·Product code HSD·March 31, 2011

    CONTAK RENEWAL 3 RF

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS, INC·Product code NIK·May 8, 2008

    C8701, S ALEXIS LAP SYS W/ KII FIOS 5/BX

    FDA Adverse Event
    Malfunction ·APPLIED MEDICAL RESOURCES·Product code GCJ·November 14, 2016

    PKG, BLAKESLY BIOPSY FORCEPS, SPOON W/PIN, P/N 0250080293. 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

    INFUSAID IMPLANTABLE INFUSION PUMP

    FDA Adverse Event
    Injury ·STRATO/INFUSAID, INC.·Product code LKK·July 17, 1997

    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