BEUDAMED
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    ACON STREP A RAPID TEST STRIP

    FDA 510(k)
    FDA Class 1 ·Microbiology

    STREP A RAPID TEST STRIP (THROAT SWAB)

    FDA Adverse Event
    Death ·ABON BIOPHARM (HANGZHOU) CO., LTD.·Product code GTY·March 25, 2024

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·H65890105820·Zirlux 17 Degree Multi-Unit Abutment 2.5 mmH co...

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0105020·Implant Inserter, 14-16mm, Sleeved

    UNBRANDED

    FDA UDI
    FGX INTERNATIONAL INC.·00193033176061·

    UNBRANDED

    FDA UDI
    FGX INTERNATIONAL INC.·00193033176054·

    UNBRANDED

    FDA UDI
    FGX INTERNATIONAL INC.·00193033176078·

    LIBERTY 9000 BREAST COIL WITH DISPOSABLE BIOPSY PLATE

    FDA 510(k)
    FDA Class 2 ·Radiology

    FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, CAT NO 11001

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC·Product code NBW·December 27, 2016

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·March 15, 2013

    PENUMBRA SYSTEM SEPARATOR 032

    FDA Adverse Event
    Injury ·PENUMBRA INC.·Product code NRY·March 1, 2011

    ATLAS + HF CRT-D

    FDA Adverse Event
    Death ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·March 10, 2008

    Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System.

    FDA Enforcement
    Class II ·Completed·Accuray Incorporated·September 6, 2023

    Oridion CO2 sampling lines and water traps under the label: MicroStreamC02 Sampling Lines: FilterLine Set Adult/Pediatric -Part No: XS04620-01; FilterLine Set Adult/Pediatric (100 unit boxes)-Part No. 010579; FilterLine H Set Adult/Pediatric -Part No. XS04624 ; FilterLine H Set Adult/Pediatric (100 unit boxes) Part No: 010580; FilterLine H Set Infant/Neonatal-Part No. 006324; FilterLine Set Adult/Pediatric Long Part No. 007768; FilterLine H Set Adult/Pediatric Long Part No. 007737; FilterLine H Set Infant/Neonatal Long Part No. 007738 Smart CapnoLine Plus (O2 connector) Part No. 009818 Smart CapnoLine Plus (O2 connector) (Special 100 unit boxes) - Part No.; 010209; Smart CapnoLine Plus Long (O2 connector) Part No. 010340; Smart CapnoLine Plus Long (O2 connector) (Special 100 unit boxes) Part No: 010339; Smart CapnoLine Plus O2 (O2 tubing) Part No. 009822 Smart CapnoLine Plus O2 (O2 tubing) (Special 100 unit boxes) Part No. 010210; Smart CapnoLine Plus O2 Long (O2 tubing) Part No. 009826; Smart CapnoLine Plus O2 Long (O2 tubing) (Special 100 unit boxes) , Part No. 010341; Smart CapnoLine Pediatric Part No. 007266 Smart CapnoLine O2 Pediatric (O2 tubing) Part No. 07269; Smart CapnoLine O2 Pediatric Long (O2 tubing) Part No.007743; Smart CapnoLine H Plus O2 (O2 tubing) Part No. 010433; Smart CapnoLine H O2 Adult (O2 tubing) Part No. 010478; Smart CapnoLine H O2 Intermediate (O2 tubing) Part No; 010475; Smart CapnoLine H Pediatric (O2 connector) Part No. 010581; Smart CapnoLine H O2 Pediatric (O2 tubing) Part No. 010582 O2 CO2 Nasal FilterLine Adult (O2 connector) Part No. 010207; O2 CO2 Nasal FilterLine Adult (O2 tubing) Part No. 006912; O2 CO2 Nasal FilterLine Adult Long (O2 connector) Part No. 010342; O2 CO2 Nasal FilterLine Adult Long (O2 tubing) Part No. 007739; O2 CO2 Nasal FilterLine Pediatric (O2 tubing) Pat No. 006913; O2 CO2 Nasal FilterLine Long (O2 tubing) Part No 007740; NIV Line Adult Part No. 008174; NIV Line Pediatric Part No. 008175; Nasal FilterLine Infant/Neonatal Part No. XS0447; CapnoLine H Adult Part No. 008177; CapnoLine H Pediatric Part No. 008178; CapnoLine H Infant/Neonatal Part No. 008179; CapnoLine H O2 Adult (O2 tubing) Part No. 008180; CapnoLine H O2 Pediatric (O2 tubing) Part No. 008181; CapnoLine H O2 Infant/Neonatal (O2 tubing) Part No. 012111; VitaLine H Set Adult/Pediatric Part No. 010787; VitaLine H Set Infant/Neonatal Part No. 010807; FilterLine XL Part No. 006325; Smart CapnoLine Guardian Part No. 012528; Smart CapnoLine Guardian O2 Part No. 012529; Smart CapnoLine Guardian O2 Long Part No. 012530

    FDA Recall
    Terminated ·Oridion Medical·Product code CCK·February 16, 2012

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: 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

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014

    Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·October 2, 2019