BEUDAMED
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    DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA SYST

    FDA 510(k)
    FDA Class 2 ·Immunology

    HairCheck-DT (Amphetamines)

    FDA UDI
    Quest Diagnostics·00868586000230·HairCheck-DT (Amphetamines) is an ELISA test ki...

    MODIFICATION TO THE EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL OSR9J229

    FDA 510(k)
    FDA Unclassified ·Unknown

    ULTRAPEN REUSABLE PENCIL, MODEL 130350 THROUGH 130353, REUSABLE ACCESSORY ELECTRODE KIT (FOR USE WITH ULTRAPEN PENCIL),

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

    PRECISION MONTAGE MRI

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 25, 2023

    ASR XL TAP SLV ADAP 12/14+2

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·April 26, 2013

    C-REACTIVE PROTEIN (LATEX)

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code DCN·May 9, 2011

    PHILIPS BRILLANCE 64 CT

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL·Product code JAK·July 23, 2008

    PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

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

    PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code KRO·April 23, 2026

    Brand Name: RX Accunet Embolic Protection System Common Name: RX Accunet EPS. Part Numbers: 101649-45, 1011649-55, 1011649-65, 1011649-75, 1011650-55, 1011650-65, 1011651-45, 1011651-55. The RX Accunet EPS is indicated for use as a guide wire and embolic protection system.

    FDA Enforcement
    Class II ·Terminated·Abbott Vascular·February 6, 2013

    LGN PRSFT STEM 10MMX220MM STRT

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·October 19, 2017

    LEGION HK HINGE KNEE SYSTEM

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code KRO·March 15, 2025

    Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701, and 702 modules; and cobas e 602 and 801 modules). Chemistry Analyzer (photometric discrete), for clinical use Part Number: 08763662001

    FDA Enforcement
    Class II ·Ongoing·Roche Diagnostics Operations, Inc.·January 6, 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