BEUDAMED
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    OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR PHENCYCLIDINE

    FDA 510(k)
    FDA Unclassified ·Unknown

    Zavation

    FDA UDI
    Zavation LLC·00842166185258·Torque Limiting Handle

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694033459·Lone Surgeon Plate 2.2mm, 30 Degree, Mini, 4 Ho...

    VirtuTRAX Instrument Navigator

    FDA UDI
    CIVCO MEDICAL INSTRUMENTS CO., INC.·10841436101889·Sterile navigator with (8.9 tapered to 1.3 x 14...

    UNKNOWN

    FDA Adverse Event
    Injury ·WILLIAM COOK EUROPE·Product code DTK·August 14, 2015

    INFARED EAR THERMOMETER, MODEL TH8 SERIES

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NORMOCARB STERILE BICARBONATE RENAL DIALYSIS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    CS100 INTRA-AORTIC BALLOON PUMP, REFURBISHED, ENGLISH,NON-UTS,DOM

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP. - MAHWAH·Product code DSP·December 16, 2020

    PROMOTE RF CRT-D

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·May 9, 2013

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 3, 2014

    ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·May 24, 2011

    BD LEUCOCOUNT¿

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code GKZ·June 21, 2023

    VirtuTRAX Instrument Navigator, 10 17 GA VirtuTRAX

    FDA Enforcement
    Class II ·Terminated·Civco Medical Instruments Co. Inc.·December 29, 2021

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH 0 DEGREE LINER 28MM 46MM, REF 130-28-05; b. ACUMATCH 0 DEGREE LINER 28MM 48MM, REF 130-28-06; c. ACUMATCH 0 DEGREE LINER 28MM 50/52MM, REF 130-28-07; d. ACUMATCH 0 DEGREE LINER 28MM 54/56MM, REF 130-28-08; e. ACUMATCH 0 DEGREE LINER 28MM 58/64MM, REF 130-28-09; f. ACUMATCH 15 DEGREE LINER 22MM SZ D, REF 132-22-04; g. ACUMATCH 15 DEGREE LINER 22MM SZ E, REF 132-22-05; h. ACUMATCH 15 DEGREE LINER 22MM SZ F, REF 132-22-06; i. ACUMATCH 15 DEGREE LINER 22MM SZ G, REF 132-22-07; j. ACUMATCH 15 DEGREE LINER 22MM SZ H, REF 132-22-08; k. ACUMATCH 15 DEGREE LINER 28MM SZ E, REF 132-28-05; l. ACUMATCH 15 DEGREE LINER 28MM SZ F, REF 132-28-06; m. ACUMATCH 15 DEGREE LINER 28MM SZ G, REF 132-28-07; n. ACUMATCH 15 DEGREE LINER 28MM SZ H, REF 132-28-08; o. ACUMATCH 15 DEGREE LINER 28MM SZ J, REF 132-28-09; p. ACUMATCH 15 DEGREE LINER 28MM SZ K, REF 132-28-10; q. ACUMATCH 15 DEGREE LINER 32MM SZ G, REF 132-32-07; r. ACUMATCH 15 DEGREE LINER 32MM SZ H, REF 132-32-08; s. ACUMATCH 15 DEGREE LINER 32MM SZ J, REF 132-32-09; t. ACUMATCH 15 DEGREE LINER 32MM SZ K, REF 132-32-10; u. ACUMATCH EXT COV LINER 28MM 46MM, REF 134-28-05; v. ACUMATCH EXT COV LINER 28MM 48MM, REF 134-28-06; w. ACUMATCH EXT COV LINER 28MM 50/52MM, REF 134-28-07; x. ACUMATCH EXT COV LINER 28MM 54/56MM, REF 134-28-08; y. ACUMATCH EXT COV LINER 28MM 58/64MM, REF 134-28-09; z. ACUMATCH EXT COV LINER 28MM 66/70MM, REF 134-28-10; aa. ACUMATCH LAT LINER 28MM 46MM, REF 138-28-05; bb. ACUMATCH LAT LINER 28MM 48MM, REF 138-28-06; cc. ACUMATCH LAT LINER 28MM 50/52MM, REF 138-28-07; dd. ACUMATCH LAT LINER 28MM 54/56MM, REF 138-28-08; ee. ACUMATCH LAT LINER 28MM 58/64MM, REF 138-28-09; ff. ACUMATCH 15 DEG LINER, SZ F, 28MM ID, REF CSK-1663; gg. ACUMATCH 15 DEG LINER, SZ G, 28MM ID, REF CSK-1664; hh. ACUMATCH 15 DEG LINER, SZ H, 28MM ID, REF CSK-1665

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022