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

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    Filters FDA Enforcement × Classification: Class Ii × Clear all

    Left Atrial Catheter Set

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·March 21, 2018

    Custodiol HTK Solution, 500ml bottle. 10 per carton.

    FDA Enforcement
    Class II ·Ongoing·Dr Franz Koehler Chemie Gmbh·October 2, 2024

    Brand Name: Finesse BTK Multicath Product Name: Injectable Angioplasty Balloon Catheter Model/Catalog Number: FS252251502 Product Description: 5 French sheath, 0.014" guidewire compatible over-the-wire injectable angioplasty balloon catheter, balloon diameter 2.5mm, balloon length 225mm, catheter working length 150cm Component: NA

    FDA Enforcement
    Class II ·Ongoing·SUMMA THERAPEUTICS, LLC·April 8, 2026

    Grace Medical REF S-4500 *** spineX BONE DUST COLLECTOR *** 2 stainless steel filters - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.

    FDA Enforcement
    Class II ·Ongoing·Oto Med Inc·May 12, 2021

    Grace Medical REF S-3500 *** COX BONE DUST COLLECTOR *** 2 stainless steel filters - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.

    FDA Enforcement
    Class II ·Ongoing·Oto Med Inc·May 12, 2021

    Grace Medical REF S-2500 *** SHEEHY BONE DUST COLLECTOR *** Stainless steel filter - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.

    FDA Enforcement
    Class II ·Ongoing·Oto Med Inc·May 12, 2021

    Artix MT Thrombectomy Device, REF: 32-102

    FDA Enforcement
    Class II ·Ongoing·Inari Medical - Oak Canyon·May 14, 2025

    Medline convenience kits labeled as: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398281J ; 2) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398650AG; 3) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398650AI; 4) ANGIOGRAPHY DRAPE PK, Pack Number 00-398712S ; 5) CATH LAB PACK , Pack Number 00-398725AM; 6) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399360K ; 7) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399734N ; 8) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399983Q ; 9) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399983R ; 10) ANGIOGRAPHY DRAPE PACK, Pack Number 00-400065K ; 11) ANGIO PROCEDURE PACK, Pack Number 00-400069F ; 12) ANGIOGRAPHY DRAPE PACK PTCA , Pack Number 00-400123AC; 13) ANGIOGRAPHY DRAPE PACK PTCA , Pack Number 00-400123AD; 14) ANGIO PROCEDURE PACK, Pack Number 00-400290D ; 15) ANGIOGRAPHY DRAPE PACK, Pack Number 00-400305Q ; 16) MOUNT SINAI HOSPITAL-ANGIO PK , Pack Number 00-400763F ; 17) ANGIOGRAPHY DRAPE PACK-LF , Pack Number 00-400863J ; 18) ANGIOGRAPHY DRAPE , Pack Number 00-400932O ; 19) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401030S ; 20) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401178D ; 21) ANGIO PROCEDURE PACK, Pack Number 00-401189I ; 22) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401226K ; 23) ANGIOGRAPHY DRP PK PEDI CATH, Pack Number 00-401318L ; 24) ANGIOGRAPHY DRP PK PEDI CATH, Pack Number 00-401318M ; 25) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401327Y ; 26) CORONARY ANGIO PACK-LF, Pack Number 00-401594Q ; 27) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401620J ; 28) ANGIO PROCEDURE PACK, Pack Number 00-401824AA; 29) CATH LAB PACK-LF, Pack Number 00-HCT055P ; 30) CATH ACCESSORY PACK , Pack Number 0M-CP31433G; 31) CATH ACCESSORY PACK , Pack Number 0M-CP31433I; 32) ANGIO PACK, Pack Number 0M-CP31933C; 33) ANGIOGRAPHY PACK-LF , Pack Number 0M-CP32357I; 34) ANGIOGRAPHY PACK-LF , Pack Number 0M-CP32357J; 35) ANTERIOR CERVICAL CDS-LF, Pack Number CDS982292D ; 36) CABG 1, Pack Number CDS983663J ; 37) CATH CDS, Pack Number CDS984141I ; 38) ENDO AAA, Pack Number CDS984264I ; 39) ANGIOGRAPHY OR, Pack Number CDS984944C ; 40) ACCESS CATHETER , Pack Number CDS985507F ; 41) ARTHROSCOPY SHOULDER, Pack Number CDS985509F ; 42) SYMPHONY 5FR CATHETER KIT , Pack Number CTK-5K ; 43) SYMPHONY MAX 6FR CATHETER KIT , Pack Number CTK-6K ; 44) NEURO ANGIO PACK, Pack Number DYNDA1431A; 45) ANGIOGRAPHY PACK-LF , Pack Number DYNJ0048560A ; 46) SJ CATH LAB PACK-LF , Pack Number DYNJ0101429L ; 47) SJ CATH LAB PACK-LF , Pack Number DYNJ0101429N ; 48) ANGIO TRAY-LF , Pack Number DYNJ0131200P ; 49) ANGIOGRAM , Pack Number DYNJ0149444J ; 50) ANGIOGRAM , Pack Number DYNJ0149444K ; 51) ANGIOGRAM , Pack Number DYNJ0149444M ; 52) EP LAB DEVICE PACK-LF , Pack Number DYNJ0160556D ; 53) PED CATH PROCEDURE CHILD PK-LF, Pack Number DYNJ0161241F ; 54) ANGIO PACK-LF , Pack Number DYNJ0165039M ; 55) ANGIO PACK-LF , Pack Number DYNJ0165039N ; 56) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0194989AF; 57) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0194989AG; 58) VASCULAR ANGIO PACK-LF, Pack Number DYNJ0201109AG; 59) ANGIOGRAPHY TRAY-LF , Pack Number DYNJ0220880V ; 60) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0241256L ; 61) ANGIO PACK-LF , Pack Number DYNJ0281048I ; 62) ANGIOGRAPHY PACK-LF , Pack Number DYNJ0290716L ; 63) ANGIO PROCEDURE PACK-LF , Pack Number DYNJ0298504AG; 64) ANGIOGRAPHIC PACK-LF, Pack Number DYNJ0337491C ; 65) ARTERIOGRAM PACK-LF , Pack Number DYNJ0362293D ; 66) CATH LAB PACK-LF, Pack Number DYNJ0362352M ; 67) CATH PACK-LF, Pack Number DYNJ0367643Q ; 68) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0370415I ; 69) CATH LAB PACK-LF, Pack Number DYNJ0371696O ; 70) ANGIOGRAPHY PACK-LF , Pack Number DYNJ0372025G ; 71) OR ANGIOGRAPHY PACK-LF, Pack Number DYNJ0373098K ; 72) OR ANGIOGRAPHY PACK-LF, Pack Number DYNJ0373098L ; 73) OR ANGIOGRAPHY PACK-LF, Pack Number DYNJ0373098M ; 74) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0373221O ; 75) ANGIO PACK-LF , Pack Number DYNJ0373279M ; 76) INTERVENTIO

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

    Medline procedure packs containing Shenli syringes, labeled as follows: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398281J ; 2) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398650AG; 3) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398650AI; 4) ANGIOGRAPHY DRAPE PK, Pack Number 00-398712S ; 5) CATH LAB PACK , Pack Number 00-398725AM; 6) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399360K ; 7) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399734N ; 8) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399983Q ; 9) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399983R ; 10) ANGIOGRAPHY DRAPE PACK, Pack Number 00-400065K ; 11) ANGIO PROCEDURE PACK, Pack Number 00-400069F ; 12) ANGIOGRAPHY DRAPE PACK PTCA , Pack Number 00-400123AC; 13) ANGIOGRAPHY DRAPE PACK PTCA , Pack Number 00-400123AD; 14) ANGIO PROCEDURE PACK, Pack Number 00-400290D ; 15) ANGIOGRAPHY DRAPE PACK, Pack Number 00-400305Q ; 16) MOUNT SINAI HOSPITAL-ANGIO PK , Pack Number 00-400763F ; 17) ANGIOGRAPHY DRAPE PACK-LF , Pack Number 00-400863J ; 18) ANGIOGRAPHY DRAPE , Pack Number 00-400932O ; 19) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401030S ; 20) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401178D ; 21) ANGIO PROCEDURE PACK, Pack Number 00-401189I ; 22) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401226K ; 23) ANGIOGRAPHY DRP PK PEDI CATH, Pack Number 00-401318L ; 24) ANGIOGRAPHY DRP PK PEDI CATH, Pack Number 00-401318M ; 25) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401327Y ; 26) CORONARY ANGIO PACK-LF, Pack Number 00-401594Q ; 27) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401620J ; 28) ANGIO PROCEDURE PACK, Pack Number 00-401824AA; 29) CATH LAB PACK-LF, Pack Number 00-HCT055P ; 30) CATH ACCESSORY PACK , Pack Number 0M-CP31433G; 31) CATH ACCESSORY PACK , Pack Number 0M-CP31433I; 32) ANGIO PACK, Pack Number 0M-CP31933C; 33) ANGIOGRAPHY PACK-LF , Pack Number 0M-CP32357I; 34) ANGIOGRAPHY PACK-LF , Pack Number 0M-CP32357J; 35) ANTERIOR CERVICAL CDS-LF, Pack Number CDS982292D ; 36) CABG 1, Pack Number CDS983663J ; 37) CATH CDS, Pack Number CDS984141I ; 38) ENDO AAA, Pack Number CDS984264I ; 39) ANGIOGRAPHY OR, Pack Number CDS984944C ; 40) ACCESS CATHETER , Pack Number CDS985507F ; 41) ARTHROSCOPY SHOULDER, Pack Number CDS985509F ; 42) SYMPHONY 5FR CATHETER KIT , Pack Number CTK-5K ; 43) SYMPHONY MAX 6FR CATHETER KIT , Pack Number CTK-6K ; 44) NEURO ANGIO PACK, Pack Number DYNDA1431A; 45) ANGIOGRAPHY PACK-LF , Pack Number DYNJ0048560A ; 46) SJ CATH LAB PACK-LF , Pack Number DYNJ0101429L ; 47) SJ CATH LAB PACK-LF , Pack Number DYNJ0101429N ; 48) ANGIO TRAY-LF , Pack Number DYNJ0131200P ; 49) ANGIOGRAM , Pack Number DYNJ0149444J ; 50) ANGIOGRAM , Pack Number DYNJ0149444K ; 51) ANGIOGRAM , Pack Number DYNJ0149444M ; 52) EP LAB DEVICE PACK-LF , Pack Number DYNJ0160556D ; 53) PED CATH PROCEDURE CHILD PK-LF, Pack Number DYNJ0161241F ; 54) no name , Pack Number DYNJ0161241F ; 55) ANGIO PACK-LF , Pack Number DYNJ0165039M ; 56) ANGIO PACK-LF , Pack Number DYNJ0165039N ; 57) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0194989AF; 58) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0194989AG; 59) VASCULAR ANGIO PACK-LF, Pack Number DYNJ0201109AG; 60) ANGIOGRAPHY TRAY-LF , Pack Number DYNJ0220880V ; 61) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0241256L ; 62) ANGIO PACK-LF , Pack Number DYNJ0281048I ; 63) ANGIOGRAPHY PACK-LF , Pack Number DYNJ0290716L ; 64) ANGIO PROCEDURE PACK-LF , Pack Number DYNJ0298504AG; 65) ANGIOGRAPHIC PACK-LF, Pack Number DYNJ0337491C ; 66) ARTERIOGRAM PACK-LF , Pack Number DYNJ0362293D ; 67) CATH LAB PACK-LF, Pack Number DYNJ0362352M ; 68) CATH PACK-LF, Pack Number DYNJ0367643Q ; 69) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0370415I ; 70) CATH LAB PACK-LF, Pack Number DYNJ0371696O ; 71) ANGIOGRAPHY PACK-LF , Pack Number DYNJ0372025G ; 72) OR ANGIOGRAPHY PACK-LF, Pack Number DYNJ0373098K ; 73) OR ANGIOGRAPHY PACK-LF, Pack Number DYNJ0373098L ; 74) OR ANGIOGRAPHY PACK-LF, Pack Number DYNJ0373098M ; 75) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ

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