BEUDAMED
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    IPS EMPRESS DIRECT FLOW

    FDA 510(k)
    FDA Class 2 ·Dental

    GEN4 INTERACTIVE

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828133739·GEN4 INTERACTIVE

    GEN4 INTERACTIVE

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828117203·GEN4 INTERACTIVE

    Atoll™

    FDA UDI
    Seaspine Orthopedics Corporation·10889981052195·3.5mm x 28mm Standard Screw. The Atoll OCT Spin...

    Cortium Universal OCT Spinal Fixation System

    FDA UDI
    Ulrich Medical Usa, Inc.·00814386026420·Screw, Ø 3.5mm, length 28mm, high angulation

    Sochi

    FDA UDI
    Altus Spine, LLC·00843210166308·Standard Screw, 3.5mm x 28mm

    SANARUS CORE TISSUE BIOPSY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    CRYSTAL 5000 PHASES ARRAY TMJ COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    PROSIMA PELVIC FLOOR REPAIR KIT

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTP·May 9, 2013

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 19, 2014

    LIGAMAX- APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·May 26, 2011

    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

    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

    Hemodialysis Delivery System, Software Version 2.x.

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·November 17, 2021

    Spacelabs Healthcare qube Compact Monitor, Model 91390. The Spacelabs Healthcare qube Compact Monitor (91390), functioning as either bedside or central monitors; passively displays data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. Key monitored parameters available on the Model 91390 when employing the Spacelabs Command Module, consist of ECG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output.

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

    GE Healthcare Centricity Radiology RA600 (RA600), Model Numbers: 1) 2022296-001; 2) 2033901-001; 3) 2038437-001; 4) 2038437-011; 5) 2038437-012; 6) 2038437-013; 7) 2038437-014; 8) 2038437-0XX; 9) 2098071-004; 10) 2109571-002; 11) 2109571-006; 12) 2109571-010; 13) 2109594-009; 14) 2109594-011; 15) K2090PS; 16) K2090PTED; 17) MANLEGACY114; 18) MANLEGACY64.

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare·April 9, 2025