BEUDAMED
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    Filters Classification: Class Ii × Status: Ongoing × Clear all

    STAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB Meter as an in vitro diagnostic for blood ketone values.

    FDA Enforcement
    Class II ·Ongoing·Stanbio Laboratory, LP·December 13, 2023

    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET 15 DROP W/ CARESITE EXT SET; Catalog Number: 490528. 2. 111 IN. IV ADMIN SET W/ 12 IN. Y-EXT SET; Catalog Number: 490550. 3. IV ADMIN SET, 125 IN. w/ EXT SET 9 IN.; Catalog Number: 490605. 4. IV SET 15 DR 3CARESITE 2 ULTRAPORT; Catalog Number: 490616. 5. IV ADMIN SET, 2 CARSITE LADS; Catalog Number: 490654.

    FDA Enforcement
    Class II ·Ongoing·B Braun Medical Inc·December 3, 2025

    Brand Name: MST Duet Reusable Handle for Single Use Heads Product Name: Reusable Handle for Single Use Heads (Forceps and Scissors) Model/Catalog Number: DFH-1028 Software Version: N/A Product Description: A MST Single Use Forceps or Scissors System consists of a reusable handle and one of a number of single use interchangeable heads. MST Single Use Forceps and Scissor heads are shipped ready to use sterile in a tray with Tyvek lid within a sterile pouch. MST Duet Reusable Handle for Single Use Forceps & Scissor Heads are supplied in a non-sterile condition and must be sterilized prior to and after every use. The blue sleeve the handle is packaged in is not intended to be sterilized and does not maintain sterility. Component: Yes. The MST Duet¿ Reusable Handle for Single Use Heads is the reusable handle component which connect to either Single Use Forceps or Scissors heads.

    FDA Enforcement
    Class II ·Ongoing·MicroSurgical Technology Inc·December 4, 2024

    DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065. The Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only.

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter Inc.·May 21, 2025

    Atellica IM 1300 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN 11066001

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics, Inc.·July 14, 2021

    Atellica CH 930 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN 11067000

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics, Inc.·July 14, 2021

    Atellica IM 1600 Analyzer- multi-component system for in vitro diagnostic testing of clinical specimens SMN 11066000

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics, Inc.·July 14, 2021

    Express Dry Seal Chest Drains (Express): 4000-100N DRAIN, EXPRESS, SINGLE; 4050-100N DRAIN, EXPRESS, BRU

    FDA Enforcement
    Class II ·Ongoing·Atrium Medical Corporation·November 22, 2023

    LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02

    FDA Enforcement
    Class II ·Ongoing·ICU Medical, Inc.·December 31, 2025

    Oasis Dry Suction Water Seal Chest Drains (Oasis): (1)3600-100 DRAIN, OASIS SINGLE W/AC; (2)3612-100 DRAIN, OASIS PEDI A/C; (3)3650-100 DRAIN, OASIS BRU W/AC;

    FDA Enforcement
    Class II ·Ongoing·Atrium Medical Corporation·November 22, 2023

    OMTMO One Step Ovulation (LH) Test Strips REF 200-07

    FDA Enforcement
    Class II ·Ongoing·Universal Meditech Inc.·November 1, 2023

    PrestiBio Pregnancy Strips REF 100-4 25 HCG Test Strips

    FDA Enforcement
    Class II ·Ongoing·Universal Meditech Inc.·November 1, 2023

    Ocean Water Seal Chest Drains (Ocean): Products REF Number Product Name (1)2002-000 DRAIN, OCEAN SINGLE W/AC,S; (2)2002-040 DRAIN, OCEAN SINGLE,PEDI CONNECTOR; (3)2002-100 DRAIN, OCEAN SINGLE W/AC; (4)2002-300 DRAIN, OCEAN SINGLE W/S; (5) 2002-400 DRAIN, OCEAN SINGLE ; (6)2012-320 DRAIN, OCEAN PEDI W/S; (7)2050-000 DRAIN, OCEAN BRU W/AC,S

    FDA Enforcement
    Class II ·Ongoing·Atrium Medical Corporation·November 22, 2023

    PrestiBio Rapid Detection Pregnancy Test Midstream REF 100-17 3 TESTS

    FDA Enforcement
    Class II ·Ongoing·Universal Meditech Inc.·November 1, 2023

    Lem Fertility LH Ovulation Test (Strip) REF 200-07

    FDA Enforcement
    Class II ·Ongoing·Universal Meditech Inc.·November 1, 2023

    HealthyWiser KetoFast" Ketone Test Strips REF 900-1K 150 test strips

    FDA Enforcement
    Class II ·Ongoing·Universal Meditech Inc.·November 1, 2023

    PrestiBio KETONE TEST STRIPS REF 900-1KET 100 STRIPS/+50 FREE

    FDA Enforcement
    Class II ·Ongoing·Universal Meditech Inc.·November 1, 2023

    Lem Fertility hCG Pregnancy Urine Test REF 100-12

    FDA Enforcement
    Class II ·Ongoing·Universal Meditech Inc.·November 1, 2023

    DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test REF 555-10

    FDA Enforcement
    Class II ·Ongoing·Universal Meditech Inc.·November 1, 2023

    DiagnosUS Pregnancy Test Midstream REF 100-17

    FDA Enforcement
    Class II ·Ongoing·Universal Meditech Inc.·November 1, 2023