BEUDAMED
    3 results · 6ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1004

    FDA Enforcement
    Class II ·Terminated·Kelyniam Global, Inc.·May 23, 2018

    JMS, Japan, 3 WAY, 20 FR 10 mL Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens constructed in the wall of the tube. One minor lumen is for inflating the retention balloon (available in 2-Way & 3-Way catheters). The second minor lumen (applicable for 3 Way catheters only) is used for bladder irrigation purposes.

    FDA Enforcement
    Class II ·Terminated·Convatec Inc.·March 26, 2014

    Medline procedural kits labeled as: 1) TYMPANOPLASTY , Pack Number CDS980203S; 2) MAJOR EAR , Pack Number CDS982016T; 3) MAJOR EAR PACK, Pack Number CMPJ01846O; 4) EAR PACK, Pack Number CMPJ05884J; 5) MZ EAR PACK , Pack Number CMPJ09860D; 6) KIT MAJOR EAR CHRG, Pack Number CMPJ09914C; 7) ENT PACK, Pack Number CMPJ13389A; 8) ENT PACK, Pack Number CMPJ13389B; 9) ENT PACK, Pack Number CMPJ13389C; 10) DR LIN EAR PACK , Pack Number CMPJ13509 ; 11) TYMPANOPLASTY PACK, Pack Number CMPJ21114O; 12) EAR PACK-LF , Pack Number DYNJ0425965G ; 13) EAR PACK-LF , Pack Number DYNJ0774664K ; 14) HL EAR PACK , Pack Number DYNJ40560B; 15) HL EAR PACK , Pack Number DYNJ40560BH; 16) EAR PACK, Pack Number DYNJ44134C; 17) EAR PACK, Pack Number DYNJ44134D; 18) EAR PACK, Pack Number DYNJ44134F; 19) MINOR ENT PACK, Pack Number DYNJ45577A; 20) ENT PACK, Pack Number DYNJ48595 ; 21) MH NASAL, Pack Number DYNJ49888I; 22) MH NASAL, Pack Number DYNJ49888J; 23) MIDDLE EAR OR , Pack Number DYNJ52583G; 24) MIDDLE EAR OR , Pack Number DYNJ52583J; 25) MIDDLE EAR OR , Pack Number DYNJ52583L; 26) ***, Pack Number DYNJ52583M; 27) GLENNON HEAD AND NECK PACK-LF , Pack Number DYNJ57200A; 28) MIDDLE EAR PACK , Pack Number DYNJ65935A; 29) ENT PACK, Pack Number DYNJ66039B; 30) FACIAL PACK , Pack Number DYNJ82177B; 31) FACIAL PACK , Pack Number DYNJ82177BH; 32) EAR CUSTOM PACK , Pack Number DYNJ82564 ; 33) ***, Pack Number DYNJ86113 ; 34) EAR , Pack Number DYNJ901779J; 35) MZ EAR CDS, Pack Number DYNJ905642D; 36) PACK MAJOR EAR CHRG , Pack Number DYNJ905694C; 37) ENT , Pack Number DYNJ909128A; 38) ENT , Pack Number DYNJ909128C; 39) ENT , Pack Number DYNJ909128D; 40) ***, Pack Number DYNJ909128D; 41) DR LIN EAR, Pack Number DYNJ909251; 42) T AND A , Pack Number DYNJ909941; 43) ***, Pack Number DYNJ909941

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