BEUDAMED
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    CERVICAL STANDALONE INTERVERTEBRAL BODY FUSION DEVICE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04047872673150·LEVAMED STABILI-TRI ANK SUP BLU L III

    JOBST Bella Strong

    FDA UDI
    BSN MEDICAL, INC.·00035664009670·BELLA STRONG 20-30 MM HG ARMSLEEVE KNIT WELT SI...

    Diagon

    FDA UDI
    CAMBER SPINE TECHNOLOGIES, LLC·B030MO1023230·Trial, Offset Bi-Convex, 10 x 34mm, 13mm.

    LESION HUNTER ROTATABLE NITINOL COLD SNARE 10 MM

    FDA Adverse Event
    Malfunction ·MICRO-TECH (NANJING) CO., LTD.·Product code GAE·April 22, 2025

    BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ADVANCED UROSCIENCE INJECTION NEEDLE

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

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 2, 2024

    ARISE 1000 EX

    FDA Adverse Event
    Injury ·JOERNS HEALTHCARE·Product code FNM·December 20, 2023

    HEARTMATE II SYSTEM CONTROLLER

    FDA Adverse Event
    Malfunction ·THORATEC CORP.·Product code DSQ·April 30, 2013

    SPECIFY

    FDA Adverse Event
    Malfunction ·MEDTRONIC VASCULAR·Product code GZB·April 14, 2008

    URETERSCOPE

    FDA Adverse Event
    Injury ·GYRUS ACMI, INC·Product code FGB·May 19, 2011

    ENCOREANYWHERE

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·February 17, 2016

    Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410. Model Number: WA91307C. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments during open surgery, laparoscopic surgery, including single-site surgery, and endoscopic surgery.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·August 27, 2025

    Sensis/ Sensis Vibe systems with software VD1X as follows: (1)Sensis Model 10764561 (2) Sensis Vibe Hemo Model 11007641 (3)Sensis Vibe Combo Model 11007642 Intended Use: A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·November 24, 2021

    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

    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

    Model Number L231, PROPONENT DR EL MRI Pacemaker

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

    Model Number L210 PROPONENT SR SL Pacemaker

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

    Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·July 14, 2021