BEUDAMED
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    AUDIT MICROCV PROCALCITONIN LINEARITY

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Bur PM2-70 80K diam EC Ø4.0x80 St

    FDA UDI
    Bien-Air Surgery SA·17630055519525·

    Oticon

    FDA UDI
    Oticon A/S·05707131164360·K13, RITE CNB

    NITANIUM® SUPER ELASTIC ARCHWIRES

    FDA UDI
    Ortho Organizers, Inc.·00190707060138·.016 UPPER NITANIUM® SUPER ELASTIC OVAL ARCH FO...

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383501101·Gutta Percha Points is used to root canal filin...

    ACCU-CHEK GUIDE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIABETES CARE, INC.·Product code NBW·July 9, 2020

    ACCU-CHEK GUIDE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIABETES CARE, INC.·Product code NBW·July 9, 2020

    'COTTONY' II DACRON, SILKY II POLYDEK & TEVDEK II POLYESTER NONABSORBABLE SURGICAL SUTURE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    G7 AUTOMATED HPLC ANALYZER

    FDA 510(k)
    FDA Class 2 ·Hematology

    LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 11MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·January 17, 2025

    VASOVIEW HEMOPRO 2

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code GEI·May 3, 2013

    PIPELINE EMBOLIZATION DEVICE

    FDA Adverse Event
    Injury ·EV3 NEUROVASCULAR·Product code OUT·August 28, 2014

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEMS

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·May 25, 2011

    LINER: CC E CC LIGHT 01.26.2839STT FLAT PE LINER Ø 28 / C

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·July 28, 2022

    GALAXY G3 MINI 2MM X 4CM

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

    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

    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

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    Model Number U128, VALITUDE CRT-P EL MRI

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