BEUDAMED
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    PHARMACARIBE INHALED SALINE SOLUTIONS

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Bur PM2-70 80K diamC Ø2.0x80 St

    FDA UDI
    Bien-Air Surgery SA·17630055519617·

    Medline Industries, Inc.

    FDA UDI
    MEDLINE INDUSTRIES, INC.·10889942755769·SUTURE SET

    HHM

    FDA UDI
    Oticon A/S·05707131164148·K140, RITE STG HHM

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383501002·Gutta Percha Points is used to root canal filin...

    IL TEST PROS

    FDA 510(k)
    FDA Class 2 ·Hematology

    KAWASUMI LABORATORIES IV ADMINISTRATION SET, STANDARD

    FDA 510(k)
    FDA Class 2 ·General Hospital

    WAVEWRITER ALPHA PRIME 16

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·March 15, 2024

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 1, 2024

    ESPRIT VENTILATOR

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, INC·Product code CBK·March 7, 2019

    GREENLIGHT HPS BPH FIBER OPTIC

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS·Product code GEX·May 3, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·May 24, 2011

    SETROX S 53

    FDA Adverse Event
    Injury ·BIOTRONIK GMBH AND CO·Product code DTB·August 5, 2008

    UNK - SCREWS: LOCKING

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code HWC·July 24, 2024

    GALAXY G3 MINI 2MM X 4CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·June 30, 2020

    IR1200, IR1250(IR1200 Plus), 2020 and One Touch(R) Ping(R) Insulin Pump glucose management system. The device is intended to deliver insulin therapy.

    FDA Enforcement
    Class II ·Terminated·Animas Corporation·October 10, 2012

    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

    Spacelabs Healthcare XPREZZON Bedside Monitor, Model 91393. The Spacelabs Healthcare XPREZZON Bedside Monitor passively displays data generated by Spacelabs parameter modules, Flexport interfaces, and other Spacelabs SDLG based products as waveform and numeric displays, trends and alarms. Key monitored parameters available on the model 91393, when employing the Spacelabs Command Module consist of EGG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·March 4, 2015

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) 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

    Model Number L101, ESSENTIO DR SL Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025