BEUDAMED
    22 results · 7ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii ×

    ADDitIV 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 numbers: 1. Primary Gravity IV Set, 2 Non-Needle-Free Injection Sites; Catalog Number: V1443. 2. ADDITIVE SET W/ 3 INJ SITES -DR*; Catalog Number: V1447. 3. ADD PEDIATRIC 3 INJ LUER LOCK; Catalog Number: V1448. 4. ADULT ADD 2 INJ CKV LUER LOCK; Catalog Number: V1484.

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

    SAFELINE 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. UNIVERSAL IV ADMIN SET; Catalog Number: 352604. 2. SAFELINE ADDITIV ALTVTD 3 INJ S; Primary Gravity IV Set with 3 SafeLine Injection Sites; Catalog Number: NF1251. 3. SAFELINE PED. ADDITIVE; Primary Gravity IV Set with 3 SafeLine Injection Sites; Catalog Number: NF1290.

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

    20IN (50.8CM) BRAIDED INJ LINE, ROTATING ADAPT, List Number MX682BR

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical Asd Inc·January 24, 2024

    48IN (121.9CM) INJ LINE ROTATING ADAPT (900psi), List Number MX694R

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical Asd Inc·January 24, 2024

    Medex 20IN (50.8CM) INJ LINE ROTATING ADAPT, List Number MX682R

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical Asd Inc·January 24, 2024

    Neuro Convenience Kit

    FDA Enforcement
    Class II ·Terminated·Medline Industries Inc·December 22, 2021

    EVLP Convenience Pack/Kit

    FDA Enforcement
    Class II ·Terminated·Medline Industries Inc·December 22, 2021

    Major Vascular CDS Convenience Kit

    FDA Enforcement
    Class II ·Terminated·Medline Industries Inc·December 22, 2021

    Bedside PICC CDS Convenience Kit

    FDA Enforcement
    Class II ·Terminated·Medline Industries Inc·December 22, 2021

    Venous Access Pack-LF Convenience Kit

    FDA Enforcement
    Class II ·Terminated·Medline Industries Inc·December 22, 2021

    STOPCOCK EXT. SET W/ 3-WAY STOPCOCK WITH INJ. SITE AND SPINLOCK CONNECTOR, 22 inches and 37 inches

    FDA Enforcement
    Class II ·Terminated·B. Braun Medical, Inc.·July 16, 2014

    Infusomat UNIV 60 DROP PUMP SET, W/2 CARESITE INJ. -Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number : 490104

    FDA Enforcement
    Class II ·Ongoing·B. Braun Medical, Inc.·July 24, 2024

    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. NF1503 15 DR UNIV SPIKE, INJ SITE, BCV; Catalog Number: 490062.

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

    175" (445 cm) Y-Type Blood Set w/170 Micron Blood Filter, Hand Pump, Inj Site, Remv 3 Gang 4-Way Stopcocks w/Baseplate, 2 Clave¿, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·August 15, 2018

    REF: AH7117 111" 10 Drop Admin Set w/2 Inj Sites, Rotating Luer, Sterile R, For Veterinary Use Only, (01) 1 0887709 051475

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·May 13, 2020

    Monosof Monofilament Nylon sutures: Product Description CN-724 MONOSOF* 1 BLK 100CM GS25 X36 CN-791 MONOSOF* 2-0 BLK 100CM GCC90X36 CN-791-12 MONOSOF* 2-0 BLK 100CM GCC90 CN-793 MONOSOF* 1 BLK 100CM GCC90 X36 CN-793-12 MONOSOF* 1 BLK 100CM GCC90X12 CN-830-L MONOSOF* 1 BLK 150CM LP GS25 N-2781K MONOSOF* 5-0 BLK 45CM SS24 DAX12 SN-1647 MONOSOF* 7-0 BLK 45CM P16 X36 SN-1647G MONOSOF* 7-0 BLK 45CM P16 X12 SN-247 MONOSOF* 3-0 BLK 90CM C23 X36 SN-3686 MONOSOF* 7-0 BLK 45CM P10 X12 SN-3695 MONOSOF* 5-0 BLK 45CM P10 X12 SN-3697 MONOSOF* 6-0 BLK 45CM P10 X12 SN-3965 MONOSOF* 5-0 BLK 45CM PC11 X12 SN-5660G MONOSOF* 6-0 BLK 45CM P24 X12 SN-5665G MONOSOF* 6-0 BLK 45CM P12 X12 SN-5690G MONOSOF* 5-0 CLR 45CM P13 X12 SN-5691 MONOSOF* 4-0 CLR 45CM P13 X36 SN-5694 MONOSOF* 4-0 BLK 45CM P11 X36 SN-5696 MONOSOF* 6-0 BLK 45CM P13 X36 SN-5697 MONOSOF* 6-0 BLK 45CM P10 X36 SN-5767G MONOSOF* 6-0 BLK 45CM P11 X12 SN-630 MONOSOF* 4-0 BLK 75CM C22 X36 SN-643 MONOSOF* 5-0 BLK 75CM C13 X36 SN-667G MONOSOF* 6-0 BLK 45CM C1 X12 SN-694 MONOSOF* 2-0 BLK 90CM C18 X36 SN-871 MONOSOF* 5-0 BLK 45CM C1 X36 SN-872 MONOSOF* 4-0 BLK 45CM C1 X36 SUT GNJ-283 MONOSOF 2/0 BLK ST DA 90CM SUT N-59 MONOSOF 2-0 BLK 6X45CM PCT

    FDA Enforcement
    Class II ·Ongoing·Covidien, LP·March 8, 2023

    SURPLUG MICRO CONNECTOR Item No. 066-C3352; 111" (282 cm) Appx 13.9 ml, 15 Drop Admin Set w/3-Way Stopcock, 1 Ext, Luer Slip Item No. B30167; 32" Transfer Set w/3-Way Stopcock, Clamp, Rotating Luer Item No. B30243; 10" Ext Set w/Remv 3-Way Stopcock w/MicroClave, Clamp, Rotating Luer Item No. B33084; 3-Way High Flow Stopcock w/Rotating Luer Item No. B4020; 38" Non-DEHP Smallbore Ext Set w/2 T-Connectors/Inj Sites, Remv 3-Way Stopcock, 2 Clamps, Luer Slip Item No. B4054; 300" Ext Set w/Remv 3-Way Stopcock, Check Valve, Clamp, Rotating Luer Item No. B4121; 3 Gang 3-Way Stopcocks w/Rotating Luer Item No. B4154; 33" Ext Set w/Remv 3-Way Stopcock, Luer Lock Item No. B4171; 35" (89 cm) Transfer Set w/3-Way Stopcock, Clamp, Rotating Luer Item No. B4181; 113" 15 Drop Primary Set w/2 MicroClave, Remv 3 Gang Manifold w/2 1o2, 3 Way Stopcock, Rotating Luer, 1 Ext Item No. B5153; 131" (333 cm) Appx 17.2 mL, 20 Drop Admin Set w/4 Pre-slit Ports, MicroClave, Remv 3-Way Stopcock, Rotating Luer, 1 Ext Item No. B9900-510; 101" 15 Drop Primary Set w/2 MicroClave, Rotating Luer, 1 Smallbore T-Connector Ext w/Remv 3-Way Stopcock Item No. B99262; 140" (356 cm) Appx 18.0 ml, 15 Drop Primary Set w/3 Clave, Remv 3-Way Stopcock, Rotating Luer, 1 Ext Item No. Z0060; 140" (356 cm) Appx 17.9 mL, 15 Drop Primary Set w/BCV-Clave, 2 Clave, Remv 3-Way Stopcock, Rotating Luer, 1 Ext Item No. Z0143; 40" Ext Set w/Removable 2 Gang 3-Way Stopcocks, Pre-Pierced Port, Clamp, Rotating Luer Item No. Z1746; 136" (345 cm) Appx 18.0 ml, 10 Drop Primary Set w/3 Inj Sites, Remv 3-Way Stopcock, Rotating Luer, 1 Ext Item No. Z2003; 137" (348cm) Appx 17.5ml, 15 Drop Primary Set w/BCV-Clave, Clave, Remv 2 Gang 3-Way Stopcocks, Rotating Luer, 2 Ext Item No. Z2367; 48" Ext Set w/Remv 3-Way Stopcock, 2 Clave, MicroClave T-Conn, 3 Clamps, Rotating Luer, 1 Ext, Smallbore Item No. Z2722; 126" 15 Drop Primary Set w/3 MicroClave, Remv 2 Gang 3-Way Stopcocks, Rotating Luer, 1 Ext Item No. Z2760; 114" (290 cm) 60 Drop 150ml Burette Set (w/MicroClave Shut Off, Filter), 3 Pre-Slit Ports, Remv 3-Way Stopcock, Rotating Luer, 1 Ext, Smallbore Ext Set w/Clave Item No. Z3284; 3-Way Stopcock w/Rotating Luer Item No. Z3295; 111" (282 cm) Appx 14.0 ml, 15 Drop Primary Set w/BCV-Clave, Clave, Remv 3-Way Stopcock, Rotating Luer w/Filter Cap, 1 Ext Item No. Z3705 The ICU intravascular administration set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein).

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·November 29, 2017

    Medline Industries IV Administration and Extension Sets: 1) DBD-IV ADMIN SET,60DRP,1NEEDLE-FREE VALV, Model Number: DYNDTB0529; 2) IV ADMIN SET, 10DRP, 1NF, 92, Model Number: DYNDTB1029; 3) DBD-IVEXTSET2.4ML2 NEEDLE-FREEVLVE,35, Model Number: DYNDTB1516; 4) DBD-IV ADMIN SET, 15DRP, 1 INJECT PORT,, Model Number: DYNDTB1530; 5) DBD-IV ADMIN SET, 15DRP, ROLLER CLAMP, 6, Model Number: DYNDTB1539; 6) DBD-IV ADMIN SET, 15DRP, 3 NF, 109, Model Number: DYNDTB1545; 7) IV ADMIN SET, 20DRP, 3 NF, 109, Model Number: DYNDTB2045; 8) DBD-IVADMINSET60DRP2NEEDLE-FREEVLVE96, Model Number: DYNDTB0512; 9) DBD-IVADMINSET,60DRP3 NEEDLE-FREE VLVE11, Model Number: DYNDTB0555; 10) IV ADMIN SET, 10DRP, NF,INJ, 96, Model Number: DYNDTB1022; 11) DBD-IV ADMIN SET, 15DRP, 2NF, 96, Model Number: DYNDTB1512; 12) DBD-IV ADMIN SET, 15DRP, 1NF, 92, Model Number: DYNDTB1529; 13) DBD-IV ADMIN SET, 15DRP, ROLLER CLAMP, 9, Model Number: DYNDTB1537; 14) DBD-IV ADMIN SET, 15DRP, SECOND, 40, Model Number: DYNDTB1540; 15) IV ADMIN SET, 20DRP, 1NF, 92, Model Number: DYNDTB2029; 16) DBD-IV EXT SET, 6.5, 1.1ML, M LUERLOCK,, Model Number: DYNDTB5077; 17) IV ADMIN SET, 10DRP, 3 NF, 109, Model Number: DYNDTB1045; 18) DBD-IVADMISET15DRP4NEEDLEFREE VLVESTPCK1, Model Number: DYNDTB1545D; 19) IV ADMIN SET15DRPFLWCTRL1NEEDLEFREE VA, Model Number: DYNDTB2524; 20) IV ADMIN SET, 10DRP, 2NF, 96, Model Number: DYNDTB1012; 21) IV ADMIN SET, 20DRP, 2NF, 96, Model Number: DYNDTB2012; 22) IV ADMIN SET, 20DRP, NF,INJ, 96, Model Number: DYNDTB2022; 23) DBD-IV EXT SET,SMBORE EXT,8,M LUERLOCK,1, Model Number: DYNDTB5081

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·February 25, 2026

    Medline convenience kits, labeled as: 1) PAIN SERVICES CDS , Pack Number CDS985445B ; 2) PAIN SERVICES CDS , Pack Number CDS985445C ; 3) PAIN TRAY , Pack Number DYNDA1233B ; 4) PAIN TRAY , Pack Number DYNDA2402A ; 5) C ARM BLOCK PACK, Pack Number DYNDA2795; 6) SINGLE DOSE EPI TRAY, Pack Number DYNDA2965; 7) MAMMOGRAPHY TRAY, Pack Number DYNDH1094; 8) FTMC PAIN TRAY, Pack Number DYNDH1239D; 9) LUMBAR PUNCTURE - CHLORAPREP, Pack Number DYNDH1351B ; 10) PAIN MANAGEMENT PACK, Pack Number DYNDH1697; 11) PAIN MANAGEMENT PACK, Pack Number DYNDH1697A ; 12) EPIDURAL TRAY , Pack Number DYNDH1739; 13) PAIN MANAGEMENT TRAY, Pack Number DYNDH1823; 14) PAIN KIT MARSHFIELD , Pack Number DYNDH1842; 15) PAIN TRAY , Pack Number DYNDH1938; 16) PAIN SERVICE PACK-LF, Pack Number DYNJ0101290C ; 17) PAIN SERVICE PACK-LF, Pack Number DYNJ0101290D ; 18) PAIN SERVICE PACK-LF, Pack Number DYNJ0101290F ; 19) MANAGEMENT PAIN PACK-LF , Pack Number DYNJ0377378G ; 20) MANAGEMENT PAIN PACK-LF , Pack Number DYNJ0377378I ; 21) STERILE PAIN PACK-LF, Pack Number DYNJ0384670F ; 22) EPIDURAL PAIN INJ (O.I) PK-LF , Pack Number DYNJ0429265G ; 23) EPIDURAL PAIN INJ (O.I) PK-LF , Pack Number DYNJ0429265I ; 24) EPIDURAL PAIN INJ (O.I) PK-LF , Pack Number DYNJ0429265J ; 25) EPIDURAL PAIN INJ (O.I) PK-LF , Pack Number DYNJ0429265K ; 26) EPIDURAL PAIN INJ (O.I) PK-LF , Pack Number DYNJ0429265L ; 27) EPIDURAL PAIN INJ (O.I) PK-LF, Pack Number DYNJ0429265M; 28) PANCREAS DONOR PACK-LF, Pack Number DYNJ0429318F ; 29) MINOR ACUTE PACK-LF , Pack Number DYNJ0484979C ; 30) STANDARD BIOPSY PACK-LF , Pack Number DYNJ0487701G ; 31) LOCAL PACK-LF , Pack Number DYNJ0554526I ; 32) ESI PACK-LF , Pack Number DYNJ0562716G ; 33) PAIN MANAGEMENT - EDOC PACK-LF, Pack Number DYNJ0625993I; 34) BGMC MJR ORAL/MAXILLO PACK-LF , Pack Number DYNJ0664646B ; 35) FREE FLAP RECIPIENT PACK-LF , Pack Number DYNJ0773964J ; 36) FREE FLAP RECIPIENT PACK-LF , Pack Number DYNJ0773964K ; 37) FREE FLAP RECIPIENT PACK-LF , Pack Number DYNJ0773964L ; 38) DSA PACK-LF , Pack Number DYNJ0843713D ; 39) STANDARD BIOPSY PACK-LF , Pack Number DYNJ0904575C ; 40) LOCALS PACK-LF, Pack Number DYNJ0939707; 41) EP TRAY , Pack Number DYNJ21808D ; 42) PAIN MANAGEMENT , Pack Number DYNJ26879B ; 43) PAIN MANAGEMENT MINOR-LF, Pack Number DYNJ28384L ; 44) PAIN MANAGEMENT MINOR-LF, Pack Number DYNJ28384M ; 45) PAIN MANAGEMENT MINOR-LF, Pack Number DYNJ28384N ; 46) PAIN MANAGEMENT MINOR-LF, Pack Number DYNJ28384O ; 47) FACET , Pack Number DYNJ28549D ; 48) PAIN MANAGEMENT PACK, Pack Number DYNJ30042A ; 49) PAIN MANAGEMENT KIT , Pack Number DYNJ30500; 50) PAIN MANAGEMENT KIT , Pack Number DYNJ30500A ; 51) PAIN BLOCKS PACK, Pack Number DYNJ31717B ; 52) PAIN BLOCKS PACK, Pack Number DYNJ31717C ; 53) PAIN BLOCKS PACK, Pack Number DYNJ31717D ; 54) RADIOLOGY EPIDURAL 0906005-LF , Pack Number DYNJ32775K ; 55) UNIVERSAL BLOCK TRAY;EXT LINE , Pack Number DYNJ33057; 56) CONTINUOUS EPIDURAL TRAY-LF , Pack Number DYNJ34352B ; 57) CONTINUOUS EPIDURAL TRAY-LF , Pack Number DYNJ34352C ; 58) LOCAL BASIC , Pack Number DYNJ34418I ; 59) LOCAL BASIC , Pack Number DYNJ34418L ; 60) LOCAL BASIC , Pack Number DYNJ34418M ; 61) PATIENT PREP TRAY , Pack Number DYNJ34489D ; 62) SOFT PAIN TRAY-LF , Pack Number DYNJ35270C ; 63) PAIN MANAGEMENT , Pack Number DYNJ36528A ; 64) PAIN MANAGEMENT , Pack Number DYNJ36528B ; 65) LOCAL PROCEDURE PACK, Pack Number DYNJ38148C ; 66) LOCAL PROCEDURE PACK, Pack Number DYNJ38148D ; 67) BASIC PAIN PACK-LF, Pack Number DYNJ38623F ; 68) BASIC PAIN PACK-LF, Pack Number DYNJ38623G ; 69) BASIC PAIN PACK-LF, Pack Number DYNJ38623I; 70) SINGLE DOSE EPIDURAL TRAY-LF, Pack Number DYNJ39178B ; 71) PAIN PROCEDURE PACK , Pack Number DYNJ40804D ; 72) BLOCK PACK, Pack Number DYNJ44205B ; 73) BLOCK PACK, Pack Number DYNJ44205D ; 74) EP PACK 319704, Pack Number DYNJ44602C ; 75) PAIN PACK , Pack Number DYNJ45913A ; 76) PAIN PACK , Pack Number DYNJ45913B ; 77) PAIN PACK , P

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 4, 2024

    Halyard Closed Suction System for Adults, Multi-Access¿Port¿Closed¿Suction¿System¿for¿Adults. Used to aspirate liquids or semisolids from a patient's upper airway. a. HALYARD* MULTI-PORT, DSY, ENDO 10FR; b. HALYARD* MULTI-PORT, DSY, ENDO 12FR; c. HALYARD* MULTI-PORT, DSY, ENDO, MDI 12FR; d. HALYARD* MULTI-PORT, DSY, ENDO 14FR; e. HALYARD* MULTI-PORT, DSY, TRACH 14FR; f. HALYARD* MULTI-PORT, DSY, TRACH, WP 14FR; g. HALYARD* MULTI-PORT, DSY, ENDO, MDI 14FR; h. HALYARD* MULTI-PORT, DSY, ENDO, WP 14FR; i. HALYARD* MULTI-PORT, DSY, ENDO, WP 14FR; j. HALYARD* MULTI-PORT, DSY, ENDO, MDI 14FR; k. HALYARD* MULTI-PORT, DSY, ENDO, MDI 16FR;

    FDA Enforcement
    Class II ·Terminated·Halyard Health, Inc·April 25, 2018