BEUDAMED
    19 results · 24ms · Sources: EU EUDAMED, US FDA

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    UNIT, CAUTERY, TEHRMAL,BATTERY-POWERED

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

    TruForm

    FDA UDI
    Rmo, Inc.·00885797099709·MX MLR BDS R/L SE ASIA ASST100

    Baby Tischler Biopsy Punch Titanium

    FDA UDI
    MEDGYN PRODUCTS, INC.·M803030158·Baby Tischler Biopsy Punch Titanium 8-1/2" (21...

    VEINLASE, MODEL E50-K8-B5, SPECTRUM K8, MODEL E50-K8-B9

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

    ROCHE DIAGNOSTICS CK-MB

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·February 4, 2025

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 25, 2015

    SYNERGY

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code LGW·April 2, 2013

    AED PLUS

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·July 15, 2014

    LARGE EX-FIX COMBINATION CLAMP MR-CONDITIONAL

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018

    LARGE EX-FIX OPEN ADJ CLAMP MR-CONDITIONAL

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018

    32MM +8 LFIT V40 HEAD

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS-MAHWAH·Product code LPH·March 2, 2017

    LARGE EX-FIX OPEN ADJ CLAMP MR-CONDITIONAL

    FDA Adverse Event
    Malfunction ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code KTT·February 13, 2018

    LARGE EX-FIX 11MM CRBN FBR ROD 250MM / MR-CONDITIONAL

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018

    LARGE EX-FIX 11MM CRBN FBR ROD 300MM / MR-CONDITIONAL

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018

    LARGE EX-FIX OPEN ADJ CLAMP MR-CONDITIONAL

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018

    Spirit One A-C Powered Hospital Bed

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·May 4, 2016

    Spirit One A-C Powered Hospital Bed

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·May 4, 2016

    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