BEUDAMED
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    METAFLEXCOIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    Tasso+ Convenience Kit

    FDA UDI
    Tasso Inc.·00860006434588·Tasso+ convenience kit allows self-collection o...

    ZEVO ANTERIOR CERVICAL PLATE SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWQ·October 23, 2019

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383502054·Gutta Percha Points is used to root canal filin...

    ALLURE® MB

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807101632041·ALLURE® MB SEW .022 LOWER 3

    ZEVO ANTERIOR CERVICAL PLATE SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWQ·December 19, 2018

    OPTI-CHECK PLUS MULTI-ANALYTE CONTROL, MODEL HC7009

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    CARDO MEDICAL FEMORAL CEMENT RESTRICTOR, MODEL 503-MCRX

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    2027971-2025-101632

    FDA Adverse Event
    Injury ·NOBEL BIOCARE USA, LLC·Product code DZE·July 15, 2025

    DELTAFILL18 5MM X 20CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·November 14, 2022

    SOLITAIRE¿ REVASCULARIZATION DEVICE

    FDA Adverse Event
    Injury ·COVIDIEN (IRVINE)·Product code NRY·May 15, 2017

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 11, 2011

    E SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·April 23, 2013

    INRATIO PT/INR TEST STRIPS

    FDA Adverse Event
    Injury ·ALERE SAN DIEGO, INC.·Product code GJS·August 27, 2014

    Nasal Alar SpO2 Sensor, Adult/Pediatric SpO2 Sensor, Rx Only Product Usage: The Assurance¿ Nasal Alar SpO2 Sensor is indicated for single patient use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate from the nasal ala of adult and pediatric patients, (at least 4 years and older and weighing > 15kg). The sensor can be used in a variety of healthcare environments where compatible pulse oximetry monitors are indicated for use, under professional supervision

    FDA Enforcement
    Class II ·Terminated·Xhale Assurance, Inc.·August 7, 2019

    Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·November 29, 2017

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    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

    INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)

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

    ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)

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