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

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    MEDLINE NON-STERILE PVP SOLUTION, STERILE PACKAGING REF DYNDA2232A

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·July 19, 2023

    MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: EAR CDS, Model Number CDS980089O

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·July 19, 2023

    MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: HYSTERO PACK, Model Number DYNJ61448A

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·July 19, 2023

    MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: TOTAL KNEE THEDA, Model Number DYNJ908683A

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·July 19, 2023

    MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: OISC HAND BEAR, Model Number DYNJ902348L

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·July 19, 2023

    MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: a) OCULOPLASTY PACK, Model Number DYNJ64572A; b) EYE PACK, Model Number VAL050EEPKB

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·July 19, 2023

    Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, NEEDLE PORT, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, NEEDLE, 16 FR (5.3 MM), 5 CC, 2000 ML BAG; Dover" UNIVERSAL TRAY, 1000 ML BASIN, PVP SOLUTION, PREPPING COMPONENTS, 10 ML PRE-FILLED SYRINGE; Dover" UNIVERSAL TRAY, 1000 ML BASIN, BZK SWAB STICKS, PREPPING COMPONENTS, 10 ML PRE-FILLED SYRINGE; Dover" UNIVERSAL TRAY, 1000 ML BASIN, PVP SWAB STICKS, PREPPING COMPONENTS, 10 ML PRE-FILLED SYRINGE; Dover" UNIVERSAL TRAY, 1200 ML BASIN, PVP SWAB STICKS, PREPPING COMPONENTS, 10 CC PRE-FILLED SYRINGE; Dover" 100% SILICONE FOLEY INSERTION TRAY, 18 FR (6.0 MM), 5 CC, PREP TRAY; Dover" HYDROGEL COATED LATEX FOLEY INSERTION TRAY, 18 FR (6.0 MM), 5 CC, PREP TRAY; Dover" HYDROGEL COATED LATEX FOLEY INSERTION TRAY, 16 FR (5.3 MM), 5 CC, PREP TRAY; Dover" UNIVERSAL TRAY, 1000 ML BASIN, PVP SOLUTION, PREPPING COMPONENTS, 10 CC PRE-FILLED SYRINGE; Dover" 100% SILICONE FOLEY INSERTION TRAY, 16 FR (5.3 MM), 5 CC, PREP TRAY; Dover" URINE DRAINAGE ADD-A-FOLEY TRAY, NEEDLE SAMPLING, DRAIN TUBE, PREP TRAY; Dover" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, NEEDLE, 18 FR (6.0 MM), 5 CC, 2000 ML BAG; Dover" UNIVERSAL TRAY, 1000 ML BASIN, BZK SWAB STICKS, PREPPING COMPONENTS, 30 CC PRE-FILLED SYRINGE; Dover" UNIVERSAL TRAY, 1000 ML BASIN, PVP SOLUTION, PREPPING COMPONENTS, 30 CC PRE-FILLED SYRINGE; Dover" URINE METER ADD-A-FOLEY TRAY, 400 ML, NEEDLE SAMPLING, DRAIN SPOUT, PREP TRAY; Dover" SILICONE ELASTOMER COATED LATEX FOLEY TRAY, 16 FR (5.3 MM), 5 CC, 2000 ML DRAINAGE BAG; Dover" 100% SILICONE FOLEY CATHETER KIT, 5 CC, 2-WAY, 16 FR (5.3 MM), LUBE, STRL WATER, 10CC SYRINGE; Dover" URINE DRAINAGE ADD-A-FOLEY TRAY, NEEDLE SAMPLING, DRAIN TUBE, PREP TRAY; Dover" URINE DRAINAGE ADD-A-FOLEY TRAY, NEEDLE SAMPLING, A/R CHAMBER, DRAIN SPOUT, PREP TRAY; Dover" UNIVERSAL TRAY, 1000 ML BASIN, PVP SWAB STICKS, PREPPING COMPONENTS, 30 CC PRE-FILLED SYRINGE

    FDA Enforcement
    Class I ·Ongoing·Cardinal Health 200, LLC·February 28, 2024

    STERILE PVP, REF DYNDA1649

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·December 20, 2023

    STERILE PVP SOLUTION, REF DYNDA1907

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·December 20, 2023

    PVP SOLUTION SING STRL, REF DYNDA1858

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·December 20, 2023

    STERILE PVP SLN KIT, REF DYNDM1097

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·December 20, 2023

    MEDLINE SWABSTICKS PVP 3 PK, Product Code DYNDA2724

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·April 10, 2024

    DYNAREX Dynarex SWABSTICK, PVP (3/PK 25/BX 10BX/CS) Catalog #1202

    FDA Enforcement
    Class II ·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·August 31, 2022

    MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: a) TOTAL JOINT, Model Number CDS985555S; b) TOTAL KNEE, Model Number CDS985566Q; c) MAJOR ORTHO-LF, Model Number DYNJ0949139I; d) BSHR TOTAL KNEE-LF, Model Number DYNJ24525K; e) BSHR TOTAL HIP-LF, Model Number DYNJ24526P; f) TOTAL KNEE ARTHROPLASTY PACK, Model Number DYNJ26425L; g) TOTAL KNEE PACK 319735, Model Number DYNJ44635I; h) HIP ARTHROPLASTY PACK, Model Number DYNJ50072F; i) LEXINGTON TOTAL JOINT PACK, Model Number DYNJ55655L; j) TOTAL JOINT, Model Number DYNJ57827D; k) ANTERIOR HIP PACK, Model Number DYNJ59126B; l) TOTAL HIP PACK, Model Number DYNJ60918A; m) MAIN TOTAL JOINT, Model Number DYNJ61376C; n) TOTAL HIP PACK, Model Number DYNJ63383; o) ANTERIOR PACK, Model Number DYNJ64814A; p) TOTAL JOINT PACK, Model Number DYNJ64951; q) TOTAL KNEE PACK-EOSC, Model Number DYNJ65093B; r) TOTAL KNEE PACK-CSC, Model Number DYNJ65108F; s) MERCY ANTERIOR HIP, Model Number DYNJ66913A; t) TOTAL PACK, Model Number DYNJ68468C; u) TOTAL KNEE-LF, Model Number DYNJ69153F; v) TOTAL JOINT PACK, Model Number DYNJ80372B; w) ANTERIOR HIP PACK, Model Number DYNJ82038; x) HIP PACK, Model Number DYNJ82345A; y) TOTAL HIP PACK, Model Number DYNJ82627A; z) TOTAL KNEE PACK LEXINGTON CLIN, Model Number DYNJ83553; aa) TOTAL JOINT PACK, Model Number DYNJ83567A; bb) TOTAL KNEE ACCESSORY PACK, Model Number DYNJ83885; cc) HIP PACK, Model Number DYNJ84051; dd) TOTAL KNEE PACK, Model Number DYNJ84054; ee) OISC HAND KORCEK, Model Number DYNJ902351F; ff) TOTAL HIP, Model Number DYNJ903149D; gg) OISC TOTAL HIP BOTTROS, Model Number DYNJ904154O; hh) TOTAL HIP, Model Number DYNJ904331I; ii) TOTAL KNEE, Model Number DYNJ904332J; jj) CRANIOTOMY, Model Number DYNJ905330B; kk) TRAUMA-RAMA, Model Number DYNJ905886G; ll) ANTERIOR HIP, Model Number DYNJ907831D; mm) TOTAL HIP-LF, Model Number DYNJ908127B; nn) TOTAL KNEE-LF, Model Number DYNJ908128B; oo) TOTAL HIP CDS, Model Number DYNJ908331A; pp) TOTAL KNEE THEDA, Model Number DYNJ908683A; qq) TOTAL HIP-LF, Model Number DYNJ909000; rr) TOTAL KNEE-LF, Model Number DYNJ909002; ss) TOTAL HIP, Model Number DYNJ909198A; tt) HIP MOFFIT PPS-LF, Model Number DYNJ9428703Q; uu) LOWER EXTREMITY PPS-LF, Model Number DYNJ9428745R; vv) UPPER EXTREMITY SHOULDER PPS, Model Number DYNJ9428787O

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·July 19, 2023

    Dover URINE METER ADD-A-FOLEY TRAY, 200 ML, NEEDLE SAMPLING PORT, DRAIN TUBE, PREP TRAY; Dover UNIVERSAL TRAY, 1000 ML BASIN, PVP SWAB STICKS, PREPPING COMPONENTS, 30 CC PRE-FILLED SYRINGE; Dover URINE DRAINAGE ADD-A-FOLEY TRAY, NEEDLE SAMPLING, A/R, DRAIN TUBE, PREP TRAY, 30 ML SYRINGE; Dover HYDROGEL COATED LATEX FOLEY TRAY 16 FR (5.3 MM), 5 CC, 2000 ML DRAINAGE BAG, DRAIN TUBE; Dover 100% SILICONE FOLEY TRAY, NEEDLE PORT, 18 FR (6.0 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover 100% SILICONE FOLEY TRAY, NEEDLE PORT, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover SILICONE COATED LATEX FOLEY TRAY, 18 FR (6.0 MM), 5 CC, 2000 ML DRAINAGE BAG, DRAIN TUBE; Dover SILICONE COATED LATEX FOLEY TRAY, 16 FR (5.3 MM), 5 CC, 2000 ML DRAINAGE BAG, DRAIN TUBE; Dover HYDROGEL COATED LATEX FOLEY TRAY, LL, 18 FR (6.0 MM), 5 CC, 2000 ML BAG, DRAIN SPOUT, CSD; Dover HYDROGEL COATED LATEX FOLEY TRAY, LL, 16 FR (5.3 MM), 5 CC, 2000 ML BAG, DRAIN SPOUT, CSD; Dover 100% SILICONE FOLEY TRAY, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, CATH SECUREMENT; Dover 100% SILICONE FOLEY TRAY, LUER LOCK, 18 FR (6.0 MM), 5 CC, 2000 ML DRAIN BAG, CATH SECUREMENT; Dover URINE METER ADD-A-FOLEY TRAY, 400 ML, TOP VENT, LUER-LOCK SAMPLING, DRAIN SPOUT, PREP TRAY; Dover 100% SILICONE SILVER-HYDROGEL COATED FOLEY TRAY, 16 FR (5.3 MM), 5 CC, 2-WAY, CATH SECUREMENT; Dover 100% SILICONE SILVER-HYDROGEL COATED FOLEY TRAY, 14 FR (4.7 MM), 5CC, 2-WAY, 2000ML DRAIN BAG; Dover 100% SILICONE FOLEY TRAY, LUER LOCK, 18 FR (6.0 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover HYDROGEL COATED LATEX FOLEY TRAY, NEEDLELESS, 16 FR (5.3 MM), 5 CC, 2000 ML BAG, DRAIN SPOUT; Dover 100% SILICONE FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG, CATH SECUREMENT; Dover 100% SILICONE FOLEY TRAY, LUER LOCK, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover 100% SILICONE FOLEY TRAY, NEEDLE PORT, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN TUBE; Dover HYDROGEL COATED LATEX FOLEY TRAY, 16 FR (5.3 MM), 5 CC, 2000 ML DRAINAGE BAG, DRAIN SPOUT; Dover 100% SILICONE FOLEY TRAY, NEEDLELESS, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover 100% SILICONE 400 ML U/M FOLEY TRAY, LUER LOCK, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG; Dover URINE DRAINAGE ADD-A-FOLEY TRAY, NEEDLE SAMPLING, DRAIN TUBE, PREP TRAY; Dover URINE DRAINAGE ADD-A-FOLEY TRAY, NEEDLE SAMPLING, DRAIN TUBE, PREP TRAY, 30 ML LUBE SYRINGE; Dover 100% SILICONE FOLEY TRAY, NEEDLE PORT, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover HYDROGEL COATED LATEX FOLEY TRAY, 18 FR (6.0 MM), 5 CC, 2000 ML DRAINAGE BAG, DRAIN SPOUT; Dover HYDROGEL COATED LATEX FOLEY TRAY, 14 FR (4.7 MM), 5 CC, 2000 ML DRAINAGE BAG, DRAIN SPOUT; Dover HYDROGEL COATED LATEX FOLEY TRAY, LUER LOCK, 14 FR (4.7 MM), 5 CC, 2000 ML BAG, DRAIN SPOUT; Dover 100% SILICONE FOLEY TRAY, NEEDLE PORT, 18 FR (6.0 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN TUBE; Dover HYDROGEL COATED LATEX FOLEY TRAY, 16 FR (5.3 MM), 5 CC, 2000 ML DRAINAGE BAG, DRAIN SPOUT ; Dover HYDROGEL COATED LATEX FOLEY TRAY, 18 FR (6.0 MM), 5 CC, 2000 ML DRAINAGE BAG, DRAIN SPOUT; Dover HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, NEEDLELESS, 16 FR (5.3 MM), 5 CC, 2000 ML BAG; Dover HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, LUER LOCK, 18 FR (6.0 MM), 5 CC, 2000 ML BAG; Dover 100% SILICONE 200 ML U/M FOLEY TRAY, NEEDLE PORT, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover URINE DRAINAGE ADD-A-FOLEY TRAY, NEEDLELESS SAMPLING, A/R CHAMBER, DRAIN SPOUT, PREP TRAY; Dover HYDROGEL COATED LATEX FOLEY TRAY, NEEDLELESS, 14 FR (4.7 MM), 5 CC, 2000 ML BAG, DRAIN SPOUT; Dover HYDROGEL COATED LATEX FOLEY TRAY, NEEDLELESS, 18 FR (6.0 MM), 5 CC, 2000 ML BAG, DRAIN SPOUT; Dover" 100% SILICONE FOLEY TRAY, NEEDLELESS, 18 FR (6.0 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover HYDROGEL COATED LATEX TRAY, LL, 14 FR (4.7 MM), 5 CC, 2000 ML BAG, DRAIN SPOUT, CSD; Dover 100% SILICONE SILVERHYDROGEL FOLEY TRAY; Dover Silicone 100% 16FR/18F; Dover 100% Silver Hydro tray

    FDA Enforcement
    Class I ·Ongoing·Cardinal Health 200, LLC·February 28, 2024

    Medline custom medical procedure kits labeled as: 1) VP SHUNT CDS, REF CDS983470D; 2) 1/2X1/2 NEURO SPONGE PACK-LF, REF DYNJ0713177; 3) BURR HOLE SHUNT PACK, REF DYNJ56819D; 4) BURR HOLE SHUNT PACK, REF DYNJ56819F; 5) BURR HOLE SHUNT PACK, REF DYNJ56819G; 6) RO VP SHUNT PACK, REF PHS392834010D; 7) VP SHUNT, REF SYNJ10307A.

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·January 8, 2025

    Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. VP SHUNT, Medline Kit Number/SKU CDS840193V; 2. SHY VP SHUNT CDS, Medline Kit Number/SKU CDS982389J; 3. VP SHUNT ADULT PACK-LF, Medline Kit Number/SKU DYNJ0117497G; 4. PICC LINE PACK, Medline Kit Number/SKU DYNJ04592K; 5. VP SHUNT PACK-LF, Medline Kit Number/SKU DYNJ0750993L; 6. PEDI VP SHUNT ADD A PACK-LF, Medline Kit Number/SKU DYNJ0753933F; 7. A-V FISTULA PACK GH-LF, Medline Kit Number/SKU DYNJ39861B; 8. A-V FISTULA PACK GH-LF, Medline Kit Number/SKU DYNJ39861D; 9. EVD VP SHUNT DBS PACK 319705, Medline Kit Number/SKU DYNJ44603C; 10. BURR HOLE SHUNT PACK, Medline Kit Number/SKU DYNJ56819G; 11. CHRISTUS CHILDRENS VP SHUNT PK, Medline Kit Number/SKU DYNJ61174A; 12. FREE FLAP PACK, Medline Kit Number/SKU DYNJ68213C; 13. FREE FLAP PACK, Medline Kit Number/SKU DYNJ68213F; 14. NASAL ENDO PACK, Medline Kit Number/SKU DYNJ84501; 15. RO VP SHUNT PACK, Medline Kit Number/SKU PHS392834010D.

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·May 6, 2026