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

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    Filters Classification: Class Ii ×

    15 g R.K. Epidural Needle (TW), Catalog #/REF #100-1415 Intended for the epidural placement, directly or through an epidural catheter, of anesthetic agents to elicit regional anesthesia

    FDA Enforcement
    Class II ·Terminated·Epimed International, Inc.·November 9, 2016

    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

    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

    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

    adult defibrillation, cardioversion, pacing, monitoring Disposable Electrodes, Model P-211-M1 and P-214-M1. Product Usage: Used by trained professionals in hospitals, doctors offices, and Emergency Medical Services for adult low-energy defibrillation, transcutaneous pacing, cardioversion and monitoring.

    FDA Enforcement
    Class II ·Terminated·TZ Medical Inc.·June 5, 2013

    Neptune Plus (Hemostatic Pad), Part Numbers: 8870-03 Neptune Pad is used to promote the rapid control of bleeding and provide hemostasis for lacerations, abrasions, vascular access sites and following surgical incision. It can be used to achieve hemostasis at the skin surface for arterial/venous catheterization/tubes, needle puncture, hemodialysis and in patients on anticoagulation therapy

    FDA Enforcement
    Class II ·Terminated·TZ Medical, Inc.·November 2, 2016

    Neptune Plus, HEMOSTASIS PAD WITH ANTIMICROBIAL BARRIER, For hemostasis following needle/sheath removal, Part number 8870-03

    FDA Enforcement
    Class II ·Terminated·TZ Medical Inc.·November 25, 2015

    SilverStat, sterile 2" x 2 " calcium alginate hemostasis pad with sliver nitrate, Part number 8870-07. Product Usage: SilverStat is an effective barrier to microbial penetration for moderate to heavy exudating partial and full-thickness wounds, including pressure ulcers, venous ulcers, diabetic ulcers, donor and graft sites, traumatic and surgical wounds and 1st and 2nd degree bums. SilverStat is indicated for external use only.

    FDA Enforcement
    Class II ·Terminated·TZ Medical Inc.·November 25, 2015

    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

    Medline Convenience kits, labeled as: 1) SINGLE SHOT EPIDURAL PACK-LF, Pack Number DYNJ0708470K ; 2) EPIDURAL CSTM PACK-LF , Pack Number DYNJ0844004; 3) CUSTOM EPIDURAL PACK-LF , Pack Number DYNJ0934752F ; 4) EPIDURAL PACK-LF, Pack Number DYNJ0957053D ; 5) EPIDURAL PACK-LF, Pack Number DYNJ0957053DH; 6) SINGLE SHOT TRAY, Pack Number DYNJ32736; 7) CONTINUOUS EPIDURAL TRAY-LF , Pack Number DYNJ34352A ; 8) SINGLE SHOT EPIDURAL-LF , Pack Number DYNJ36046A ; 9) PHOENIXVILLE EPIDURAL TRAY, Pack Number DYNJ40991A ; 10) UNIVERSAL SCOPE PACK, Pack Number DYNJ45052A ; 11) SPINAL PACK , Pack Number DYNJ48916B ; 12) PUH SPINAL BLOCK TRAY , Pack Number DYNJ49205B ; 13) EPIDURAL PACK , Pack Number DYNJ50772A ; 14) TRANSFORAMINAL PACK , Pack Number DYNJC3420D ; 15) EPIDURAL PREP TRAY-LF , Pack Number DYNJRA0135B; 16) SUPPORT TRAY-LF, Pack Number DYNJRA0198; 17) SPINAL TRAY W/GERTIE MARX NDL , Pack Number DYNJRA0245 ; 18) EPIDURAL TRAY , Pack Number DYNJRA0260 ; 19) SPINAL EPIDURAL (TUOHY) PF, Pack Number DYNJRA0270B; 20) EPIDURAL TRAY-LF, Pack Number DYNJRA0275A; 21) SPINAL BLOCK TRAY- LF , Pack Number DYNJRA0413B; 22) SINGLE SHOT EPIDURAL TRAY-LF, Pack Number DYNJRA0506A; 23) EPIDURAL TRAY , Pack Number DYNJRA0508 ; 24) SPINAL TRAY W/GERTIE MARX NDL , Pack Number DYNJRA0555 ; 25) COMBINED SPINAL/EPIDURAL PACK , Pack Number DYNJRA0635 ; 26) SPINAL BLOCK, 25G QUINCKE , Pack Number DYNJRA0766 ; 27) TRANSFORAMINAL 22X5PF , Pack Number DYNJRA0777F; 28) TRANSFORMINAL TRAY, Pack Number DYNJRA0822A; 29) SPINAL TRAY, Pack Number DYNJRA0836A; 30) SPINAL TRAY , Pack Number DYNJRA0978A; 31) UNIVERSAL BLOCK TRAY, Pack Number DYNJRA0988 ; 32) TRAY, SPINAL, WHIT 24GX4, Pack Number DYNJRA1034 ; 33) TRANSFORAMINAL TRAY , Pack Number DYNJRA1730A; 34) SPINAL BLOCK 25G WHTCRE 5S BU , Pack Number DYNJRA9028 ; 35) SPINAL BLOCK 25G WHTCRE 5S BU , Pack Number DYNJRA9028H; 36) TRAY, SPINAL PENCIL POINT 25G , Pack Number DYNJRA9030 ; 37) SPINAL BLOCK TRAY, 22G QUINCKE, Pack Number DYNJRA9036 ; 38) SPINAL BLOCK TRAY, 22G QUINCKE, Pack Number DYNJRA9036H; 39) SPINAL BLOCK, 25G QUINCKE , Pack Number DYNJRA9037 ; 40) SINGLE SHOT EPIDURAL TRAY , Pack Number PAIN0012 ; 41) SINGLE SHOT EPIDURAL TRAY-LF, Pack Number PAIN0024D; 42) SINGLE SHOT EPIDURAL TRAY-LF, Pack Number PAIN0055A; 43) SINGLE SHOT EPIDURAL TRAY-LF, Pack Number PAIN0058D; 44) SINGLE SHOT EPIDURAL TRAY , Pack Number PAIN0078C; 45) SINGLE SHOT EPIDURAL TRAY , Pack Number PAIN0082D; 46) SINGLE SHOT EPIDURAL TRAY , Pack Number PAIN0111C; 47) SINGLE SHOT EPIDURAL TRAY , Pack Number PAIN0133 ; 48) COMPLETE SINGLE SHOT TRAY , Pack Number PAIN0136A; 49) SINGLE SHOT EPIDURAL TRAY-LF, Pack Number PAIN0146C; 50) SINGLE SHOT EPIDURAL TRAY , Pack Number PAIN0157G; 51) SINGLE SHOT EPIDURAL TRAY-LF, Pack Number PAIN0171C; 52) SINGLE SHOT EPIDURAL TRAY-LF, Pack Number PAIN0191I; 53) NORTON SINGLE SHOT EPIDURAL , Pack Number PAIN0215A; 54) EPIDURAL TRAY , Pack Number PAIN0225 ; 55) SINGLE SHOT EPIDURAL TRAY-LF, Pack Number PAIN0242B; 56) SINGLE SHOT EPIDURAL-LF , Pack Number PAIN0250A; 57) SINGLE SHOT EPIDURAL-LF , Pack Number PAIN0256B; 58) SINGLE SHOT EPIDURAL TRAY-LF, Pack Number PAIN0261A; 59) SINGLE SHOT EPIDURAL TRAY-LF, Pack Number PAIN0262A; 60) SINGLE SHOT EPIDURAL TRAY-LF, Pack Number PAIN0265C; 61) EPI TRAY, SINGLE , 20G-LF , Pack Number PAIN0274A; 62) EPI TRAY CONTI 17G TUOHY, Pack Number PAIN0275 ; 63) EPIDURAL TRAY-LF, Pack Number PAIN0279C; 64) SINGLE SHOT EPIDURAL TRAY-LF, Pack Number PAIN0280C; 65) SINGLE DOSE EPI-LF, Pack Number PAIN0300B; 66) SINGLE DOSE EPIDURAL TRAY-LF, Pack Number PAIN0317A; 67) SINGLE SHOT EPIDURAL TRAY-LF, Pack Number PAIN0334A; 68) EPIDURAL TRAY-LF, Pack Number PAIN0349B; 69) SINGLE DOSE EPIDURAL TRAY-LF, Pack Number PAIN0357B; 70) SHOT EPIDURAL TRAY-LF , Pack Number PAIN0362 ; 71) SINGLE SHOT EPIDURAL TRAY , Pack Number PAIN0386B; 72) CONTINUOUS EPIDURAL TRAY, Pack Number PAIN0390 ; 73) SINGLE SHOT EPIDURAL T

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 18, 2024