BEUDAMED
    18 results · 10ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii ×

    MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER W/ GEL, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688EU, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·February 19, 2014

    MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER WITH GEL, featuring IsoSilk(R), 13cm x 249 cm, REF 3688UK, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·February 19, 2014

    MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688N, QTY 100, Microtek Medical, Inc., Columbus, MS 39702.

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·February 19, 2014

    BD FlowSmart Set MiniMed Pro-set Rx Only Distributed by Medtronic MiniMed Inc. 8006464633 8185765555 Legal Manufacturer Becton, Dickinson and Company USA BD Medical-Diabetes Care Becton Dickinson France SAS

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Company·May 10, 2017

    MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER W/ GEL, featuring IsoSilk(R), 5" x 98", (13cm x 249 cm), REF 3688, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·February 19, 2014

    CADD(TM) Medication Cassette Reservoir with clamp and female Luer., Nonvented stopper included., 100 mL, For use with CADD(R) pumps (except CADD-Micro(TM), CADD-MS(R) 3 and CADD-TPN(R) pumps).REF 21-7002-24, STERILE EO, Smiths Medical ASD, Inc. For use with CADD(R) pumps (except CADD-Micro(TM), CADD-MS(R) 3 and CADD-TPN(R) pumps).

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·November 8, 2017

    CADD(TM) Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included., 50 mL, For use with CADD(R) pumps (except CADD-Micro(TM), CADD-MS(R) 3 and CADD-TPN(R) pumps)., REF 21-7001-24, STERILE EO, Smiths Medical ASD, Inc. For use with CADD(R) pumps (except CADD-Micro(TM), CADD-MS(R) 3 and CADD-TPN(R) pumps).

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·November 8, 2017

    Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Cranial/ENT Navigation 3.0.x and 3.1.x - Product Usage: intended to be an intra-operative image guided localization system to enable minimally invasive surgery.

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·October 14, 2020

    Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC) with BD Medical Posiflush 10mL Saline Flush Syringe.

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·October 22, 2014

    BK Medical ApS Ultrasound System Scanner bk2300 - Model #: bk3500 with software releases 1.2.0, 1.2.1 and 1.2.2. The system is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body, data processing and guidance of puncture and biopsy. The system performs simple geometric measurements and calculations in the following areas: Emergency Medicine, Anesthesia, MSK, Vascular, Cardiology, OB/GYN

    FDA Enforcement
    Class II ·Terminated·B-K Medical A/S·August 10, 2016

    MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER WITH GEL, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·February 19, 2014

    Integra Disposable, Convenience Kit Single Shot Epidural Tray Reorder Number 340269 Rx Only Product Usage: The Integra kits which contain a BD LOR syringe are intended to provide licensed medical professionals with a kit containing drugs and other medical devices that are used to support the administration of general, local or spinal anesthetics. The BD LOR syringe is intended for use, in conjunction with an epidural needle, to verify the needle tip placement is in the epidural space by use of the Loss of Resistance Technique as detailed in medical textbooks and medical journal articles. The LOR Syringe is not intended for injection or aspiration.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp. d.b.a. Integra Pain Management·December 25, 2013

    CIVCO lnfiniti Needle Guide Bracket. used for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers. Product Usage: The bracket and disposable guide provide physicians with a tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers.

    FDA Enforcement
    Class II ·Terminated·Civco Medical Instruments Co. Inc.·August 29, 2018

    BioFlo Midline Convenience Kits - Product Usage: These introducers are used for the percutaneous introduction of diagnostic or therapeutic devices, such as catheters or pacing leads in the vasculature. Item Numbers H96560M0125711 H96560M0133541 H96560M0354721 H96560M0367081 H96560M05019121 H96560M05019131 H96560M1220291 H96560M1303161 H96560M1303181 H96560M1318211 H96560M1408911 H96560M1429481 H96560M1803431 H96560M18157131 H96560M2208531 H96560M2208541 H96560M2500981 H96560M611025111 H96560M611052811 H96560M611056011 H96560M611095811 H965PKM1387818S1 H965PKM1404211S1 H965PKM1635214S1 H965PKM220533S1 H965PKM220853S1 H965PKM220855S1 H965PKM61095322S1 H965PKM61102511S1 Cat. No. 60M012571 60M013354 60M035472 60M036708 60M0501912 60M0501913 60M122029 60M130316 60M130318 60M131821 60M140891 60M142948 60M180343 60M1815713 60M220853 60M220854 60M250098 60M61102511 60M61105281 60M61105601 60M61109581 PKM1387818S PKM1404211S PKM1635214S PKM220533S PKM220853S PKM220855S PKM61095322S PKM61102511S

    FDA Enforcement
    Class II ·Terminated·Angiodynamics, Inc.·June 24, 2020

    BioFlo Midline Catheter and BioFlo Maximal Barrier Kits - Product Usage: These introducers are used for the percutaneous introduction of diagnostic or therapeutic devices, such as catheters or pacing leads in the vasculature. Item Numbers H965460151 H965460161 H965460161-NP H965460171 H965460181 H965460221 H965460231 H965460241 H965460251 H965460261 H965460271 H965460281 H965460291 H965464601 H965464701 H965464701-NP H965464801 H965464901 Cat. No. 46-015 46-016 46-016-NP 46-017 46-018 46-022 46-023 46-024 46-025 46-026 46-027 46-028 46-029 46-460 46-470 46-480 46-490

    FDA Enforcement
    Class II ·Terminated·Angiodynamics, Inc.·June 24, 2020

    ICU Mednet(TM) Medication Management Suite 6.1 and 6.21, Product Code/List Numbers: (a) 16037-64-01; MedNet 6.1 b) 16037-64-02; MedNet 6.1 c) 16037-64-03; MedNet 6.1 d) 16037-64-04; MedNet 6.21 The ICU Medical MedNet Medication Management Suite (MMS) is intended to facilitate networked communication between MMS compatible computer systems and MedNet compatible infusion pumps. The MMS provides trained healthcare professionals with the capability to send, receive, report, and store information from interfaced external systems, and to configure and edit infusion programming parameters. The MMS is intended to provide a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data. All data entry and validation of infusion parameters is performed by a trained healthcare professional according to physician s orders.

    FDA Enforcement
    Class II ·Terminated·ICU Medical Inc·December 13, 2017

    BioFlo PICC and Xcela PICC Maximal Barrier Nursing Kits - Product Usage: are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Item Numbers H965750011 H965750031 H965750121 H965750131 H965750141 H965750151 H965750161 H965750171 H965750181 H965750191 H965750211 H965750221 H965750231 H965750241 H965750315 H965750315-NP H965750325 H965750335 H965750335-NP H965750345 H965750355 H965750355-NP H965750365 H965750375 H965750385 H965750415 H965750425 H965750441 H965750451 H965750471 H965750481 H965750491 H965750501 H965750521 H965750531 H965750541 H965750551 H965750561 H965750571 H965750581 H965750591 H965750601 H965750611 H965750621 H965750631 H965750651 H965750661 H965750671 H965750681 H965750691 H965750701 Cat. No. 75-001 75-003 75-012 75-013 75-014 75-015 75-016 75-017 75-018 75-019 75-021 75-022 75-023 75-024 75-031 75-032 75-033 75-034 75-035 75-036 75-037 75-038 75-041 75-042 75-044 75-045 75-047 75-048 75-049 75-050 75-052 75-053 75-054 75-055 75-056 75-057 75-058 75-059 75-060 75-061 75-062 75-063 75-065 75-066 75-067 75-068 75-069 75-070

    FDA Enforcement
    Class II ·Terminated·Angiodynamics, Inc.·June 24, 2020

    BioFlo PICC and Xcela PICC Convenience Kits - Product Usage: are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Item Numbers H96560M01162101 H96560M0116291 H96560M0133531 H96560M0134211 H96560M0198811 H96560M0224741 H96560M0224751 H96560M0335621 H96560M0367041 H96560M0367051 H96560M0367061 H96560M05019111 H96560M0501981 H96560M1201961 H96560M1201971 H96560M12202101 H96560M12202111 H96560M12202121 H96560M1303151 H96560M1303171 H96560M1303191 H96560M13184101 H96560M13184111 H96560M1318491 H96560M1401411 H96560M1401421 H96560M1401431 H96560M1401441 H96560M1406061 H96560M1406071 H96560M1633931 H96560M1803441 H96560M1803451 H96560M18157111 H96560M18157121 H96560M1841151 H96560M1841161 H96560M1841171 H96560M1907131 H96560M1907141 H96560M2204441 H96560M2208511 H96560M2208521 H96560M2322421 H96560M2500961 H96560M2500971 H96560M610115911 H96560M610901011 H96560M611025121 H96560M611025131 H96560M611052821 H96560M611056021 H96560M611056031 H96560M611095821 H96560M611095831 H965PKM030667S1 H965PKM120451S1 H965PKM1220226S1 H965PKM1300011S1 H965PKM1303119S1 H965PKM131935S1 H965PKM150124S1 H965PKM150125S1 H965PKM150127S1 H965PKM220851S1 H965PKM220854S1 H965PKM3092662S1 H965PKM61040701S1 H965PKM61066141S1 H965PKM61095321S1 H965PKM61095324S1 Cat. No. 60M0116210 60M011629 60M013353 60M013421 60M019881 60M022474 60M022475 60M033562 60M036704 60M036705 60M036706 60M0501911 60M050198 60M120196 60M120197 60M1220210 60M1220211 60M1220212 60M130315 60M130317 60M130319 60M1318410 60M1318411 60M131849 60M140141 60M140142 60M140143 60M140144 60M140606 60M140607 60M163393 60M180344 60M180345 60M1815711 60M1815712 60M184115 60M184116 60M184117 60M190713 60M190714 60M220444 60M220851 60M220852 60M232242 60M250096 60M250097 60M61011591 60M61090101 60M61102512 60M61102513 60M61105282 60M61105602 60M61105603 60M61109582 60M61109583 PKM030667S PKM120451S PKM1220226S PKM1300011S PKM1303119S PKM131935S PKM150124S PKM150125S PKM150127S PKM220851S PKM220854S PKM3092662S PKM61040701S PKM61066141S PKM61095321S PKM61095324S

    FDA Enforcement
    Class II ·Terminated·Angiodynamics, Inc.·June 24, 2020