BEUDAMED
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    COLLAGEN WOUND DRESSING

    FDA 510(k)
    FDA Unclassified ·Unknown

    ODYSSEY®

    FDA UDI
    Microport Orthopedics Inc.·M684K00274431·

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·10304040093877·Maxima K-Files 21mm

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·H65810024431·K-FILES 21MM #35

    ODYSSEY®

    FDA UDI
    Microport Orthopedics Inc.·M684K00124431·

    SURGITEK SILICONE BREAST IMPLANT

    FDA Adverse Event
    MEDICAL ENGINEERING CORP.·Product code FTR·June 13, 1994

    REMOTE FETAL MEDICINE ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    SUGAR CHEX ONE

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    PIPELINE EMBOLIZATION DEVICE

    FDA Adverse Event
    Injury ·EV3 NEUROVASCULAR·Product code OUT·March 13, 2013

    PROFYLE DRILL, DIAM.2.0X100MM, WL 41MM, STRYKER SH

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS FREIBURG·Product code HBE·January 28, 2011

    2008K2 HEMODIALYSIS MACHINE

    FDA Adverse Event
    Malfunction ·CONCORD MANUFACTURING·Product code KDI·June 10, 2014

    REVERSE SHOULDER SYSTEM 04.01.0155 GLENOID BASEPLATE Ø27X25

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·April 5, 2023

    BD INSYTE AUTOGUARD

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·June 23, 2025

    Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic

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

    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

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·October 2, 2019