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

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    Filters Classification: Class Ii ×

    Arrow Endurance" Extended Dwell Peripheral Catheter System, REF: ASK-00820-FLH

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·January 29, 2020

    Olympus MAJ-209 Single Use Suction Valves, Model Number MAJ-209 Product Usage: This product has been designed to be attached to the suction cylinder of compatible endoscopes for aspirating fluid from the distal end of the endoscopes through the instrument channel. Compatible endoscopes include Olympus bronchoscopes, cystoscopes, rhino-laryngoscopes and pleurascopes models.

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·August 14, 2019

    TIBIAXYS, Model Numbers: 150010S, 150020S, 150030S, 150040S, 150120S, 150110S, 150130S, 150200S, 150240S, 150242S, 150246S, 150250S, 150255S, 150260S, 150265S, 150270S, 150275S, 150280S, 150285S, 150290S, 150514S & 150516S

    FDA Enforcement
    Class II ·Terminated·NewDeal SA·July 25, 2018

    Medline Convenience kits labeled as: 1) KIT GENERAL CLOSURE , Pack Number DYKMBNDL200A ; 2) KIT GENERAL CLOSURE , Pack Number DYKMBNDL200AH; 3) CUST CHEST TUBE INSERTION X , Pack Number DYNDA2415B ; 4) LACERATION TRAY , Pack Number DYNDL1495A ; 5) LACERATION TRAY , Pack Number DYNDL1495AH; 6) LACERATION TRAY , Pack Number DYNDL1807B ; 7) LACERATION WITH INSTMTS TRAY, Pack Number DYNDL1963; 8) LACERATION WITH INSTMTS TRAY, Pack Number DYNDL1963H ; 9) LACERATION TRAY , Pack Number DYNDL1965A ; 10) STERILE RESUTURE PACK, Pack Number DYNDL1980A; 11) STERILE RESUTURE PACK, Pack Number DYNDL1980AH; 12) LACERATION TRAY , Pack Number DYNDL1981; 13) LACERATION TRAY , Pack Number DYNDL1985; 14) SUTURE TRAY , Pack Number DYNDL1986; 15) FGH FLOOR KIT , Pack Number DYNDL1989; 16) LACERATION KIT, Pack Number DYNDL1991; 17) LACERATION KIT, Pack Number DYNDL1992; 18) LACERATION KIT, Pack Number DYNDL1992H ; 19) ER LACERATION TRAY, Pack Number DYNDL1993; 20) LACERATION TRAY , Pack Number DYNDL1994; 21) CLOSURE PACK-LF , Pack Number DYNJ0807503N ; 22) CLOSING BUNDLE, Pack Number DYNJ52157I ; 23) PREMIUM CLOSUREPLUS PACK, Pack Number DYNJ54326A ; 24) ABD CLOSURE PACK, Pack Number DYNJ56987C ; 25) CLOSING PACK, Pack Number DYNJ57577A ; 26) SURGERY CLOSING KIT , Pack Number DYNJ67429B ; 27) CLOSING PACK, Pack Number DYNJ68267B ; 28) MICRODISECTOMY PACK , Pack Number DYNJ80585B ; 29) PREP TRAY , Pack Number DYNJRA1583D; 30) NECESSAIRES A POINT DE SUTURES, Pack Number M101498; 31) MAJOR LACERATION PACK-LF, Pack Number PHS751688G; 32) IR SUTURE PACK-LF , Pack Number PHS863717D ; 33) FINE LACERATION KIT , Pack Number SUT17215A; 34) MINOR LACERATION TRAY , Pack Number SUT18200 ; 35) LACERATION TRAY, Pack Number SUT20285A; 36) LACERATION TRAY W/ LIDOCAINE, Pack Number SUT20595A; 37) SNAG FREE LACERATION TRAY, Pack Number SUT21665; 38) LACERATION TRAY , Pack Number SUT21710 ; 39) LACERATION REPAIR TRAY, Pack Number SUT21780 ; 40) SNAG FREE LACERATION TRAY , Pack Number SUT21825

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

    GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare GmbH·December 24, 2025

    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DR. ROSEN VEIN PACK, Model Number: DYNJ67517; b. DR. VANBOSSE LOWER EXT PACK, Model Number: DYNJ51416B; c. DRAINAGE TRAY, Model Number: DYNJ42913, DYNJ42913A; d. ECMO PACK, Model Number: DYNJ61243; e. EGG RETRIEVAL PACK, Model Number: DYNJ66291, DYNJ66291A; f. EH TAVR PACK, Model Number: DYNJ57449A; g. ELVS PACK-LF, Model Number: DYNJ26940G; h. ENDO AAA HYBRID CHRG, Model Number: DYNJ60126; i. ENDOVASCULAR OR PACK, Model Number: DYNJ54265; j. ENDOVASCULAR PACK, Model Number: DYNJ59085; k. ENDOVASCULAR PACK-LF, Model Number: DYNJ42831D; l. ENDOVENOUS ABLATION PACK, Model Number: DYNJ53435C; m. ENDOVENOUS BASIC PACK, Model Number: DYNJ48456B; n. ENDOVENOUS CORE PACK, Model Number: DYNJ59168; o. ENDOVENOUS PACK, Model Number: DYNJ58228; p. ENS BIOPSIE THYROIDE-HEJ-LF, Model Number: DYNJ62443; q. EP LAB, Model Number: DYNJ59392C; r. EP MERCY JANESVILLE, Model Number: DYNJ907013; s. EP PACK, Model Number: DYNJ57594A; t. EVAR, Model Number: DYNJ900005L; u. EVLA PACK, Model Number: DYNJ66258; v. EVLT, Model Number: DYNJ62417, DYNJ64336; w. EVLT CORE PACK, Model Number: DYNJ45294; x. EVLT PACK, Model Number: DYNJ38674A, DYNJ45997C, DYNJ56548B, DYNJ65995, DYNJ65995A, DYNJ66005; y. FEM POP PACK, Model Number: DYNJ01964M, DYNJ67487A; z. FETAL OPEN/EXIT, Model Number: DYNJ904069C; aa. FH THORACIC PACK, Model Number: DYNJ58572B, DYNJ58572C; bb. FISTULAGRAM/C-ACCESS PACK, Model Number: DYNJ59657A; cc. FLAP, Model Number: DYNJ905146A; dd. FREE FLAP PACK CTX, Model Number: DYNJ68380C; ee. FREE FLAP PACK-LF, Model Number: DYNJ0271254P; ff. FREE FLAP TRAM ADD ON PACK, Model Number: DYNJ82179; gg. GEL ULTRASOUND 20G FOIL , Model Number: DYNJZ45357; hh. GENERAL USE PACK, Model Number: DYNJ41137B; ii. GU ROBOTIC PACK-LF, Model Number: DYNJ0972464Y; jj. GYN LITHOTOMY, Model Number: DYNJ906579C; kk. HH VARITHENA VEIN PACK, Model Number: DYNJ59500; ll. HH VEIN CLOSURE PACK, Model Number: DYNJ59501; mm. HH VEIN PICC MADISON PACK, Model Number: DYNJ59508; nn. HILLCREST PCNL PACK, Model Number: DYNJ69204B; oo. HL VEIN STRIPPING PACK, Model Number: DYNJ40374A; pp. HYBRID KIT, Model Number: DYNJ905335; qq. HYBRID OR PACK, Model Number: SYNJ10303B; rr. I.R. PACK, Model Number: DYNJ60343A; ss. INTRAUTERINE TRNSFUSION -LF, Model Number: DYNJ9048708F; tt. IR MINI KIT, Model Number: DYNJ44519F; uu. IR NEURO PACK, Model Number: DYNJ39198I; vv. IR PERIPHERAL PACK, Model Number: DYNJ45033A; ww. IR SONO PACK, Model Number: DYNDA2365, DYNDA2365B; xx. JBMH EVAR PACK, Model Number: DYNJ69820; yy. JOHNSON OH ACCESSORY PACK, Model Number: DYNJ51927A; zz. JUDKINS PACK-LF, Model Number: DYNJ0530948AR, DYNJ0586030P; aaa. JVL-PACK TUNNELED, Model Number: DYNJ66065; bbb. KF PACK, Model Number: DYNJ57547, DYNJ58647, DYNJ60127A; ccc. KF PACK 2.0, Model Number: DYNJ69619; ddd. KIDNEY CDS, Model Number: DYNJ903873C; eee. KIDNEY TRANSPLANT, Model Number: DYNJ905682; fff. KIT LAP DONOR NEPHRECTOMY, Model Number: DYKMBNDL173B; ggg. KIT LB OPEN HEART, Model Number: DYNJ902261D, DYNJ904401B; hhh. KT TAVR PACK, Model Number: DYNJ56283B; iii. LARGE PROCEDURE PACK, Model Number: DYNJ35524D; jjj. LASER ABLATION, Model Number: DYNJ80299; kkk. LASER KIT, Model Number: DYNJ64075A; lll. LASER PACK, Model Number: DYNJ39053A; mmm. LINE KIT, Model Number: DYNJ47987B; nnn. LINE PLACEMENT PACK-LF, Model Number: DYNJ0931376F; ooo. LIVER 2018, Model Number: DYNJ905655, DYNJ905655B; ppp. LIVER TRANSPLANT CDS, Model Number: CDS984951D; qqq. LIVER TRANSPLANT PACK, Model Number: DYNJ0271349T; rrr. LONESTAR RF PACK, Model Number: DYNJ83152; sss. MAD PERIPHERAL VASCULAR-LF, Model Number: DYNJ902168D; ttt. MAG FREE FLAP CDS-LF,

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·August 9, 2023