BEUDAMED
    14 results · 21ms · Sources: EU EUDAMED, US FDA

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    RAPIDPOINT 500 BLOOD GAS ANALYER

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814794·GENUMEDI EXTRA WIDE SILVER SIZE VI

    PRINCETON

    FDA UDI
    Princeton Medical Group, Inc.·00810158215559·FORCEPS OEHLER TISSUE 1X2 TEETH SERRATED TC 6.25"

    Navagio

    FDA UDI
    Kalitec Direct LLC·B07330K0132160·Trial, TLIF, 27L OB CRV 7Deg, 16mm

    EXPEDIUM SYSTEM, VIPER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DIODENT DENTAL LASER SYSTEM

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

    EPIX UNIVERSAL CLIP APPLIER

    FDA Adverse Event
    Malfunction ·APPLIED MEDICAL·Product code FZP·May 8, 2013

    FRESENIUS 2008K

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·September 2, 2014

    SCREW CORTICAL 3.5X14MM (3 EACH)

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LXT·May 20, 2011

    ARGENT SURGICAL SYSTEMS***BIOPSY Punches*** Disposable manual instrument for skin biopsy.

    FDA Enforcement
    Class II ·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    ACCOLADE DR EL MRI (Model L331)

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

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018