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

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    ZOLL STAT*PADZ MWP MULTI-FUNCTION ELECTRODES

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    LORENZ STERNAL CLOSURE SYSTEM WITH MODULAR SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PRIMAGARD YELLOW SURGICAL MASK, PLEATED, TIE-ON, PM4-307; PRIMAGARD YELLOW SURGICAL MASK, PLEATED, EAR-LOOP,PM4-308; PRM

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

    PROTECTA XT CRT-D

    FDA Adverse Event
    Injury ·IPG MFG SWITZERLAND·Product code NIK·April 10, 2013

    PULSE OXIMETER

    FDA Adverse Event
    Injury ·Product code DQA·May 21, 2008

    PEDICLE PROBE, LENKE

    FDA Adverse Event
    Injury ·ZIMMER SPINE·Product code LXH·April 5, 2011

    PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code KRR·October 15, 2025

    PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code KRR·October 20, 2025

    PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code KRR·October 15, 2025

    MicroVue CIC-C1q EIA, Model A001. The MicroVue CIC-C1q EIA is for detection of circulating immune complexes (CIC) in human serum or plasma. The MicroVue CIC-C1q EIA is for detection of circulating immune complexes (CIC) in human serum or plasma. In certain disease states, immune complexes may initiate complement mediated damage of various organs and tissues. This activation of complement may begin a series of potentially destructive events including cell lysis, the production of anaphylatoxins, leukocyte stimulation and activation of macrophages. Major tissue damage can also occur when CIC fix to cell membranes as in some cases of glomerulonephritiscirculating immune complexes (CIC) in human serum or plasma.

    FDA Enforcement
    Class III ·Terminated·Diagnostic Hybrids, Inc.·May 2, 2018

    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

    Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020