BEUDAMED
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    GEON RAPID DIGITAL THERMOMETER MODEL: MT-B117, MT-B127, MT-B130, MT-B132FA

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SleepWeaver Elan - Mask & Headgear Starter Kit - Beige

    FDA UDI
    CIRCADIANCE, LLC·B036100563·SleepWeaver Elan Cloth Nasal PAP Mask & Headgea...

    STAINLESS STEEL BRIGHT ARCHWIRE

    FDA UDI
    Ortho Organizers, Inc.·00190707066796·.021 X .025 Upper Stainless Steel Bright Standa...

    HS Diam. Burr, Ø5.0x70, 80k

    FDA UDI
    Bien-Air Surgery SA·17630055507041·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450360248·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450388051·

    N/A

    FDA UDI
    Doppkon GmbH & Co. KG·04262494463969·Guide Wire D 0.8mm, WL 450mm

    DREAMSTATION AUTO CPAP

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·January 29, 2025

    END-TO-END AND SIDE-BY-SIDE CONNECTORS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MODIFICATION TO ENVOY PATIENT MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·May 8, 2013

    PFC SIGMA C/R NPOR FEM LT SZ5

    FDA Adverse Event
    Injury ·DEPUY (IRELAND)·Product code JWH·May 17, 2011

    INVACARE

    FDA Adverse Event
    Death ·INVACARE CORP·Product code FNL·August 6, 2008

    AccessPLUS Large Bore Hemostasis Valves, Catalog Code: 580758001, 580774001, IN8152/C, K04-01197, K05T-01863, K09-09102B, K09-10388A, K09-12917, K09-13501AP, K10-05457AP, K10-05635, K10-05868P, K10-05872P, K12-08303, K12-10346, K12-10375, K12-10724AP, K12-10962, K12-11413, MAP150/F, MAP152/B, MAP152/F, K12-01551, K12-YP064A, K12-YP114, K12-YP115, K12-YS047A, IN8152, K12-01551

    FDA Enforcement
    Class II ·Ongoing·Merit Medical Systems, Inc.·April 20, 2022

    LATITUDE ELBOW ANATOMIC HUMERAL SPOOL SZ PETIT+ SIDE GAUCHE

    FDA Adverse Event
    Injury ·TORNIER INC·Product code JDC·May 7, 2024

    BACFIX ROD, UNKNOWN

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code HSB·January 16, 2020

    PORTEX

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL INTERNATIONAL, LTD.·Product code JOH·February 9, 2021

    AccessPLUS Large Bore Hemostasis Valves, Catalog Code: 580758001, 580774001, IN8152/C, K04-01197, K05T-01863, K09-09102B, K09-10388A, K09-12917, K09-13501AP, K10-05457AP, K10-05635, K10-05868P, K10-05872P, K12-08303, K12-10346, K12-10375, K12-10724AP, K12-10962, K12-11413, MAP150/F, MAP152/B, MAP152/F, K12-01551, K12-YP064A, K12-YP114, K12-YP115, K12-YS047A, IN8152, K12-01551

    FDA Recall
    Open, Classified ·Merit Medical Systems, Inc.·Product code DTL·March 1, 2022

    CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).

    FDA Enforcement
    Class II ·Terminated·CME America, LLC·December 9, 2020

    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