BEUDAMED
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    NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RUBIO WIRE TWISTER/NEEDLE HOLDER

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896082625·RUBIO WIRE TWISTER/NEEDLE HOLDER TUNGSTEN CARBI...

    NexxZr™ / W-98-16-UT-D200-ML

    FDA UDI
    SAGEMAX BIOCERAMICS, INC·00842271139658·

    PMT CORPORATION - STEREOTACTIC

    FDA UDI
    PMT CORPORATION·00650551098331·FHC BUSHING, FOR 2.4MM DRILL

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450173909·

    GLUCOSE CONTROL SOLUTION FOR THERASENSE FREESTYLE

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    LYRA SERIES SURGICAL LASER SYSTEM (SL SERIES, ND:YAG CONFIGURATION)

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

    CONTOUR TEST STRIPS (50)

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE LLC·Product code NBW·January 4, 2008

    TRUSTEEL

    FDA Adverse Event
    Malfunction ·Product code FPA·May 27, 2022

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·November 22, 2021

    GMK PRIMARY FIXED CEMENTED FEMUR SIZE 5 LEFT

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL, SA·Product code JWH·July 18, 2013

    ROD INTRODUCTION PLIERS FOR DUAL-OPENING IMPL F/6.0MM RODS

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HTC·May 9, 2013

    L-70 HOTLINE 2 FLUID WARMING SET WITHOUT INJECTION PORT

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code FPA·May 27, 2008

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 25, 2011

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

    DELTAFILL18 10MM X 40CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·September 10, 2020

    AQUAPAK 340 SW, 340ML W/040 ADAPTOR, INTL. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·February 18, 2015

    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

    VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021