BEUDAMED
    42 results · 24ms · Sources: EU EUDAMED, US FDA

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    Burlington Medical, Vest

    FDA Enforcement
    Class II ·Ongoing·Burlington Medical, LLC·April 8, 2026

    Burlington Medical, Kilt

    FDA Enforcement
    Class II ·Ongoing·Burlington Medical, LLC·April 8, 2026

    Burlington Medical, Frontal Aprons

    FDA Enforcement
    Class II ·Ongoing·Burlington Medical, LLC·April 8, 2026

    Description/REF: PI AGBA PICC KIT: 3L 6 FR X 40 CM W/VPS/ASK-44063-NS AGBA PICC/DELTA: 2L 5.5 FR X 50 CM/ASK-45052-NS AGBA PICC/DELTA KIT: 1L 4.5 FR X 55 CM/ASK-45541-MHBV PICC KIT: 2L 5.5 FR X 55 CM CG+ VPS/ASK-45552-RH AGBA PICC NaviCurve: 2L 5.5FR x 55CM BP/DLX-45552-CURVB AGBA PICC NaviCurve: 2L 5.5FR x 55CM TCG/DLX-45552-CURVC AGBA PICC: 2L 5.5FR x 55CM w Biopatch/DLX-45552-HPKB AGBA PICC NaviCurve: 3L 6FR x 55CM BP/DLX-45563-CURVB PI PICC KIT: 4 FR X 50 CM/ASK-35041-NH PI PICC KIT: 2-L 5 FR X 50 CM/ASK-35052-NH PI PICC G4 Stylet: 1L 4FR x 55CM w CHG/DLX-35541-VPSC PI PICC NaviCurve: 2L 5FR x 55CM w BP/DLX-35552-CURVB PI PICC NaviCurve: 3L 6FR x 55CM w BP/DLX-35563-CURVB PI PICC G4 Stylet: 3L 6FR x 55CM w BP/DLX-35563-VPSB AGBA PI PICC KIT: 2L 5.5 FR X 55CM/CDC-45552-HPK1A PI AGBA PICC KIT: 3-L 6 FR X 55 CM/CDC-45563-HPK1A PI AGBA PICC KIT: 1L 4.5 FR X 55 CM VPS/ASK-45541-UOI1 PICC KIT: 1L 4.5 FR X 55 CM VPS/ASK-45541-VFH1 PI AGBA PICC KIT: 2L 5.5 FR X 55 CM VPS/ASK-45552-UOI1 PICC KIT: 2L 5.5 FR X 55 CM VPS/ASK-45552-VFH1 PI AGBA PICC KIT: 3L 6 FR X 55 CM W/VPS/ASK-45563-UWH1 AGBA PICC NaviCurve: 1L 4.5FR x 55CM BP/DLX-45541-CURVB AGBA PICC NaviCurve: 1L 4.5FR x 55CM TCG/DLX-45541-CURVC AGBA PICC G4 Stylet: 1L 4.5FR x 55CM TCG/DLX-45541-VPSC AGBA PICC G4 Stylet: 2L 5.5FR x 55CM BP/DLX-45552-VPSB AGBA PICC G4 Stylet: 2L 5.5FR x 55CM TCG/DLX-45552-VPSC PI PICC:1L 4FR X 50CM PRELOAD VPS STYLET/CDC-35041-VPS PICC KIT: 3 FR X 55 CM/CDC-05531-PK1A

    FDA Enforcement
    Class I ·Ongoing·ARROW INTERNATIONAL, LLC·June 24, 2026

    Description/REF: ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM6 RA CATH KIT: 20 GA X 1-3/4IN/NA-04020-X1ASP ACCESS TRAY/ASK-04001-MS RA CATH KIT: 20 GA X 8 CM/ASK-00820-UM1 VESSEL CATH KIT: 20GA X 5IN/AK-04550-S CVC KIT: 1-LUMEN 5 FR X 20 CM/AK-04301-SP CVC KIT: 16 GA X 6IN (16 CM)/AK-04306-SP CVC KIT: 16GA X 6 IN/AK-04800-S CVC KIT: 2-LUMEN 4 FR X 5 CM/AK-12402 CVC KIT: 3-LUMEN 7 FR X 16 CM/AK-12703-CDC CVC KIT: 2L 4 FR X 13 CM/AK-14402 CVC KIT: 2-LUMEN 5 FR X 13 CM/AK-14502 CVC KIT: 3-LUMEN 5.5 FR X 30 CM/AK-14553 CVC KIT: 3-LUMEN 7 FR X 30 CM/AK-14703-SP CVC KIT: 2-LUMEN 4 FR X 8 CM/AK-15402 CVC KIT: 3-LUMEN 5.5 FR X 8 CM/AK-15553 CVC KIT: 2-LUMEN 4 FR X 30 CM/AK-16402 CVC KIT: 3-LUMEN 5.5 FR X 13 CM/AK-16553 CVC KIT: 5 FR X 20 CM/ASK-04301-HH2 CVC KIT 3L: 7 FR X 6 IN (16 CM)/ASK-12703-MGH3

    FDA Enforcement
    Class I ·Ongoing·ARROW INTERNATIONAL, LLC·June 24, 2026

    Description/REF: MIDLINE CATHETER KIT: 3 FR X 20 CM/CDC-02031-MK1A; AM/AT PI MIDLINE 1L: 4.5FR X 15CM/CDC-41541-MPK1A; AM/AT PI MIDLINE 2L: 5.5FR X 15CM/CDC-41552-MPK1A; AGBA PI MIDLINE 1L: 4.5FR X 15CM/ASK-41541-VFHM; AGBA PI MIDLINE 1-L: 4.5FR X 15CM/CDC-41541-MPK; AGBA PI MIDLINE 1-L: 4.5FR X 15CM/CDC-41541-MPKB; AGBA PI MIDLINE 1-L: 4.5FR X 15CM/CDC-41541-MPKC; AGBA PI MIDLINE 2-L: 5.5FR X 15CM/CDC-41552-MPK; AGBA PI MIDLINE 2-L: 5.5FR X 15CM/CDC-41552-MPKB; AGBA PI MIDLINE 2-L: 5.5FR X 15CM/CDC-41552-MPKC; PI MIDLINE 1-L: 4FR X 20CM/CDC-32041-MPK; PI MIDLINE 1-L: 4FR X 20CM/CDC-32041-MPKB; PI MIDLINE 1L: 4FR X 20CM/CDC-32041-MPKC; PI MIDLINE 2-L: 5FR X 20CM/CDC-32052-MPKB; PI PICC NaviCurve: 1L 4FR x 55CM w BP/DLX-35541-CURVB; PI PICC: 1L 4FR x 55CM w Biopatch/DLX-35541-HPKB; PI PICC: 1L 4FR x 55CM w CHG/DLX-35541-HPKC; PI PICC: 2L 5FR x 55CM w Biopatch/DLX-35552-HPKB; PI PICC: 2L 5FR X 55CM w CHG/DLX-35552-HPKC; PI PICC: 3L 6FR x 55CM w Biopatch/DLX-35563-HPKB; AGBA PICC/DELTA KIT: 1L 4.5 FR X 40 CM/ASK-44041-NS; AGBA PICC/DELTA FG: 2L 5.5 FR X 40 CM/ASK-44052-NS; AGBA PICC/DELTA KIT: 1L 4.5 FR X 50 CM/ASK-45041-NS; PI PICC KIT: 2L 5.5 FR X 50 CM/ASK-45052-TG; PI AGBA PICC KIT: 3L 6 FR X 50 CM W/VPS/ASK-45063-NS; PICC KIT: 1L 4.5 FR X 55 CM CG+ VPS/ASK-45541-RH; AGBA PICC: 1L 4.5FR x 55CM w Teg CHG/DLX-45541-HPKC; AGBA PICC: 2L 5.5FR x 55CM w Teg CHG/DLX-45552-HPKC; AGBA PICC NaviCurve: 3L 6FR x 55CM TCG/DLX-45563-CURVC; AGBA PICC: 3L 6FR x 55CM w Biopatch/DLX-45563-HPKB; AGBA PICC: 3L 6FR x 55CM w Teg CHG/DLX-45563-HPKC; PI PICC KIT: 1-L 4 FR X 55 CM TIPTRACKER/CDC-35541-TTS; PI PICC NaviCurve: 1L 4FR x 55CM w CHG/DLX-35541-CURVC; PI PICC G4 Stylet: 1L 4FR x 55CM w BP/DLX-35541-VPSB; PI PICC NaviCurve: 2L 5FR x 55CM w CHG/DLX-35552-CURVC; PI PICC G4 Stylet: 2L 5FR x 55CM w BP/DLX-35552-VPSB; PI PICC G4 Stylet: 2L 5FR x 55CM w CHG/DLX-35552-VPSC; PI PICC NaviCurve: 3L 6FR x 55CM w CHG/DLX-35563-CURVC; PI PICC G4 Stylet: 3L 6FR x 55CM w CHG/DLX-35563-VPSC; AGBA PICC/DELTA KIT: 1-L 4.5 FR X 40 CM/CDC-44041-VPS2; PICC KIT: 1L 4.5 FR X 55 CM VPS/ASK-45541-UWH1; PI AGBA PICC KIT: 2L 5.5FR X 55CM W/ VPS/ASK-45552-UWH1; AGBA PICC G4 Stylet: 1L 4.5FR x 55CM BP/DLX-45541-VPSB; ACCESS TRAY/ASK-04001-NWM; ACCESS TRAY/ASK-04001-VCUH3; PI PICC:1L 4FR X 40CM PRELOAD VPS STYLET/CDC-34041-VPS; PI PICC:2L 5FR X 50CM PRELOAD VPS STYLET/CDC-35052-VPS; ACCESS KIT/ASK-04001-BWK2; ARROW(R) VPS(R) ACCESS KIT/ASK-04001-DU11; MULTI LUMEN PI CVC KIT: 3L 7 FR X 6 IN/ASK-42703-PVD; MULTI LUMEN PI CVC KIT: 3L 7 FR X 16CM/ASK-12703-LMDTG1; MULTI LUMEN PI CVC KIT: 3L 7 FR X 8IN/ASK-15703-ECMC4; MULTI LUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-15703-PNM; CVC KIT: 3 LUMEN 12 FR X 6IN/ASK-22123-UAB; 2-L CVC KIT: 4 FR X13 CM/CDC-24402-X1A; LBCVC KIT: 3L 12 FR X 20 CM AGB/CDC-25123-X1A; CVC KIT: 3L 7 FR X 16 CM/ASK-42703-CPR; CVC KIT: 2L 8 FR X 6 IN (16 CM) AGB+/ASK-42802-DMC2; CVC KIT: 2 LUMEN 8 FR X 8 IN (20 CM)/ASK-45802-PCMH1; PI CVC KIT: 3L 7 FR X 6 IN (16 CM) AGB+/ASK-42703-MM1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PHUMC1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PMSG1; MULTILUMEN PI CVC KIT: 3L 7 FR X 6/ASK-42703-POSU3; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PSAU1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-RHR1; PI CATHETER 2L: 8 FR X 16 CM AGB+/ASK-42802-DU1; PI CVC KIT: 2L 8 FR X 6 IN/ASK-42802-PHF4; PI CVC KIT: 2L 8 FR X 16 CM AGB+/ASK-42802-PHHN1; MULTILUMEN CVC KIT: 2L 8 FR X 6 IN/ASK-42802-POSU3; PI CVC KIT: 2-L 8 FR X 16 CM AGB+/ASK-42802-PUCD1; MULTI-LUMEN CVC KIT:2-L 8FR X 6IN (16CM)/ASK-42802-PWHC1; PI CVC KIT: 2L 8 FR X 16 CM AGB+/ASK-42802-UHC; PI CVC KIT: 4L 8.5 FR X 16 CM AGB+/ASK-42854-MCY1; PI CVC KIT: 3L 7FR X 8IN (20 CM) AGB+/ASK-45703-BCH; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-EMC; PI CVC KIT: 3 LUMEN 7 FR X 8 IN (20 CM)/ASK-45703-MHMC1; PI CVC KIT: 3-L 7 FR X 20 CM AGB+/ASK-45703-NWM; MULTILUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-PCOR; MULTILUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-PIMH; MULTI LUMEN CVC KIT: 3L

    FDA Enforcement
    Class I ·Ongoing·ARROW INTERNATIONAL, LLC·June 24, 2026

    HydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002

    FDA Enforcement
    Class II ·Ongoing·Access Vascular, Inc·February 22, 2023

    HydroPICC 4Fr Single Lumen, 80cm Guidewire - Basic Kit, Model Number 80001002

    FDA Enforcement
    Class II ·Ongoing·Access Vascular, Inc·February 22, 2023

    HydroPICC 4Fr Single Lumen Catheter, Maximal Barrier Kit, Model Number 80001004

    FDA Enforcement
    Class II ·Ongoing·Access Vascular, Inc·May 24, 2023

    HydroPICC 4Fr Single Lumen, 130cm Guidewire - Basic Kit, Model Number 80001001

    FDA Enforcement
    Class II ·Ongoing·Access Vascular, Inc·February 22, 2023

    HydroMID 4Fr Single Lumen Maximal Barrier Kit- Indicated for short term access (<30days) to the peripheral venous access system for intravenous therapy Product Model Number: 80004004

    FDA Enforcement
    Class II ·Ongoing·Access Vascular, Inc·March 1, 2023

    HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term access (<30days) to the peripheral venous access system for intravenous therapy Product Number: 80004004

    FDA Enforcement
    Class II ·Ongoing·Access Vascular, Inc·March 1, 2023

    Injection Needle, 3 Fr., REF: 27030N; Injection Cannula, 6 Fr., REF: 27182A

    FDA Enforcement
    Class II ·Ongoing·Karl Storz Endoscopy·December 27, 2023

    Description/REF: PACING PSI KIT: 6 FR/AI-06210-KS, PACING PSI KIT: 5 FR 2-L/AI-07155-KS, PACING PSI KIT: 5 FR 2L/ASK-07155-UPM

    FDA Enforcement
    Class I ·Ongoing·ARROW INTERNATIONAL, LLC·June 24, 2026

    FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 828.051

    FDA Enforcement
    Class II ·Ongoing·Richard Wolf GmbH·May 3, 2023

    FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 8735.685

    FDA Enforcement
    Class II ·Ongoing·Richard Wolf GmbH·May 3, 2023

    FLEX. BIOPSY FORCEPS 5FR WL 550MM, Product Number 829.051

    FDA Enforcement
    Class II ·Ongoing·Richard Wolf GmbH·May 3, 2023

    Description/REF: PACING/PSI KIT: 5 FR 2L/ASK-07155-MGU

    FDA Enforcement
    Class I ·Ongoing·ARROW INTERNATIONAL, LLC·June 24, 2026

    HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004

    FDA Enforcement
    Class II ·Ongoing·Access Vascular, Inc·October 25, 2023

    Description/REF: PI MIDLINE 2L: 5FR X 20CM/CDC-32052-MPKC

    FDA Enforcement
    Class I ·Ongoing·ARROW INTERNATIONAL, LLC·June 24, 2026