BEUDAMED
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    MODIFICATION TO DEPUY CONTOUR UNICOMPARTMENTAL KNEE PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Straumann

    FDA UDI
    Preat Corporation·00842092103838·Straumann Bone Level RC Guide Pin 20mm

    PIC Tips

    FDA UDI
    PREMIER DENTAL PRODUCTS COMPANY·00348783003765·AUTO DUAL BARREL SYRINGE TIPS (25)

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092001451·artVeneer life lower anteriors, UCS, D2

    Health-Tec/DHP Hand Instruments

    FDA UDI
    Dental Health Products Inc·D77370014510·Health-Tec/DHP Hemostat Kelly Curved 5.5"

    FRESENIUS COMBILLINES SINGLE NEEDLE BLOOD TUBING SET, CATALOG #03-2290

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    RX EVEREST

    FDA 510(k)
    FDA Class 2 ·Dental

    LIFEPAK CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-001451 99512-001434 883873785911 LIFEPAK CR2: The LIFEPAK CR2 defibrillator is indicated for use on patients 1 year of age or older in cardiopulmonary arrest. The patient must be unresponsive (unconscious), not breathing normally, and showing no signs of circulation (for example, no pulse, no coughing, or no movement). The cprCOACHTM Feedback Technology in the LIFEPAK CR2 defibrillator is indicated for use on cardiopulmonary arrest patients and provides CPR guidance in accordance with the AHA Guidelines for patients 1 year of age or older. The LIFEPAK CR2 defibrillator is intended for use by personnel who have been trained in its operation. Users should have received training in basic life support/AED, advanced life support, or a physician-authorized emergency medical response training program.

    FDA Recall
    Open, Classified ·Physio-Control, Inc.·Product code MKJ·July 22, 2025

    INDIGO SYSTEM CATRX ASPIRATION CATHETER

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code QEX·April 15, 2024

    CHARGING SYSTEM

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 5, 2013

    ECHELON* 60 ENDOPATH

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·February 25, 2011

    ON-Q PAINBUSTER

    FDA Adverse Event
    Other ·I-FLOW CORP.·Product code MEB·February 12, 2008

    LIFEPAK CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-001451 99512-001434 883873785911 LIFEPAK CR2: The LIFEPAK CR2 defibrillator is indicated for use on patients 1 year of age or older in cardiopulmonary arrest. The patient must be unresponsive (unconscious), not breathing normally, and showing no signs of circulation (for example, no pulse, no coughing, or no movement). The cprCOACHTM Feedback Technology in the LIFEPAK CR2 defibrillator is indicated for use on cardiopulmonary arrest patients and provides CPR guidance in accordance with the AHA Guidelines for patients 1 year of age or older. The LIFEPAK CR2 defibrillator is intended for use by personnel who have been trained in its operation. Users should have received training in basic life support/AED, advanced life support, or a physician-authorized emergency medical response training program.

    FDA Enforcement
    Class II ·Ongoing·Physio-Control, Inc.·September 10, 2025

    ZYSTON STRAIGHT INLINE INSERTER

    FDA Adverse Event
    Injury ·BIOMET SPINE - BROOMFIELD·Product code MAX·July 12, 2016

    DISP. 34X4, 1BLA, 1PRT, QUICK CONNECT

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP·Product code KCY·January 29, 2023

    TMJ SYSTEM RIGHT STANDARD MANDIBULAR COMONENT, 55 MM

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code LZD·March 6, 2019

    TMJ SYSTEM RIGHT FOSSA COMPONENT, MEDIUM

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code LZD·March 6, 2019

    2.7 MM SYSTEM EMERGENCY CROSS DRIVE SCREW, 3.2 X 10 MM

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HWC·March 6, 2019

    2.4 MM SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, 2.7 X 10 MM

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HWC·March 6, 2019

    TMJ SYSTEM CROSS DRIVE FOSSA SCREW, 2.0 X 7 MM

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code JEY·March 6, 2019