BEUDAMED
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    ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the marking of bone and/or guide surgical instruments in mandibular and maxillofacial surgical procedures. Identification number: SD900.101

    FDA Enforcement
    Class II ·Completed·Materialise N.V.·August 9, 2023

    ARTHROSCOPY SUP JOI PACK Procedure tray Catalog Number: BPAS17C

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems Inc·July 17, 2024

    Surface Applicator Set with Leipzig-style Cone. Brachytherapy applicator set.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems Inc·July 1, 2015

    The VariSource iX series afterloader systems are computer controlled remote electro/mechanical systems used for medical purposes, for placing a cable incorporating an irradiated iridium seed internally or close by a malignant tumor or tumor bed in a practice known as brachytherapy.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems Inc·July 8, 2015

    Brand Name: Galaxy System Product Name: Galaxy System Model/Catalog Number: GAL-001 Product Description: The Galaxy SystemTM and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedure.

    FDA Enforcement
    Class II ·Ongoing·Noah Medical Corporation·December 3, 2025

    DIASTAT anti-Nuclear antibody (ANA) / DIASTAT ANA ELISA. Catalog Number: FANA200. Product Usage: The DIASTAT¿ anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of ANAs in human serum or EDTA plasma. It detects ANAs against Sm, Sm/RNP, Ro (SS-A), La (SS-B), Scl- 70, Jo-1, dsDNA, histone and centromere antigens.The test may be used to screen out samples which are negative for all ANAs. Samples that give a positive test result should be further tested to identify the antigen-specific antibody or antibodies present. Quantitative/qualitative ELISA kits are available for the individual detection of Sm, Sm/RNP, Ro (SS-A), La (SS-B), dsDNA and centromere ANAs. Qualitative kits are available for the individual detection of Scl-70 and Jo-1. ANA detection represents one parameter in a multicriterion diagnostic process.

    FDA Enforcement
    Class II ·Terminated·Euro Diagnostica AB·March 14, 2018

    DIASTAT(R) ANA (anti-Nuclear antibody) EURO DIAGNOSTICA, The DIASTAT(R) anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of ANAs in human serum or EDTA plasma. It detects ANAs against Sm, Sm/RNP, Ro (SS-A), La (SS-B), Scl-70, Jo-1, dsDNA, histone and centromere antigens.

    FDA Enforcement
    Class III ·Terminated·Euro Diagnostica AB·July 5, 2017

    Santajoy Ornament & Giftware Co., Ltd E-Z Illuminations Northern Lights E-Z Illuminations Galaxy Laser projectors that emit various colors and light patterns for entertainment and decorative purposes.

    FDA Enforcement
    Class II ·Terminated·SANTA JOY ORNAMENT & GIFTWARE CO·June 13, 2018

    Medline procedure kits labeled as: 1) ACL ARTHROSCOPY PACK, Pack Number DYNJ55316G; 2) ARTERIOGRAM PACK, Pack Number DYNJ64332; 3) ARTHRO PACK-LF, Pack Number DYNJ38748F; 4) ARTHRO PACK-LF, Pack Number DYNJ38748F; 5) ARTHROGRAM PACK, Pack Number DYNJ65817; 6) ARTHROGRAM TRAY, Pack Number DYNDH1937; 7) ARTHROSCOPY KNEE PACK-LF, Pack Number DYNJ0809731F; 8) ARTHROSCOPY PACK, Pack Number DYNJ66665; 9) ARTHROSCOPY PACK, Pack Number DYNJ38716C; 10) ARTHROSCOPY PACK, Pack Number DYNJ33639J; 11) ARTHROSCOPY PACK, Pack Number DYNJ37707D; 12) ARTHROSCOPY PACK, Pack Number DYNJ38914A; 13) ARTHROSCOPY PACK, Pack Number DYNJ64526A; 14) ARTHROSCOPY PACK, Pack Number DYNJ62755B; 15) ARTHROSCOPY PACK, Pack Number DYNJ61634B; 16) ARTHROSCOPY PACK, Pack Number DYNJ83129; 17) ARTHROSCOPY PACK, Pack Number DYNJ35906F; 18) ARTHROSCOPY PACK, Pack Number DYNJ35906F; 19) ARTHROSCOPY PACK, Pack Number DYNJ37946C; 20) ARTHROSCOPY PACK, Pack Number DYNJ68133A; 21) ARTHROSCOPY PACK BCS, Pack Number DYNJ45629B; 22) ARTHROSCOPY PACK -LF, Pack Number DYNJ0781838S; 23) ARTHROSCOPY PACK-LF, Pack Number DYNJ80469B; 24) ARTHROSCOPY PACK-SHOULDER, Pack Number DYNJ04452L; 25) ARTHROSCOPY PACK-SHOULDER, Pack Number DYNJ24507G; 26) ARTHROSCOPY TRAY, Pack Number DYNJ65948A; 27) ARTHROSCOPY TRAY, Pack Number DYNJ81547; 28) BACK PACK-LF, Pack Number DYNJ0381507N; 29) BASIC ORTHO PACK, Pack Number DYNJ67212A; 30) BASIC SPINE PACK-LF, Pack Number DYNJ39199F; 31) CLOVIS LOWER EXTREMITY-LF, Pack Number DYNJ61066C; 32) CRANIOTOMY PACK, Pack Number DYNJ45145G; 33) CRANIOTOMY PACK-LF, Pack Number DYNJ0530906AO; 34) CRANIOTOMY PACK-LF, Pack Number DYNJ38351O; 35) DL-KNEE SCOPE, Pack Number DYNJ67595B; 36) ENSEMBLE CRANIOTOMIE-LF, Pack Number DYNJ29202D; 37) ESC HAND PACK, Pack Number DYNJ42264; 38) EXTREMITY, Pack Number DYNJ52017; 39) EXTREMITY PACK, Pack Number DYNJ64167D; 40) EXTREMITY PACK, Pack Number DYNJ52104A; 41) EXTREMITY PACK, Pack Number DYNJ53915D; 42) EXTREMITY PACK, Pack Number DYNJ35046B; 43) EXTREMITY PACK, Pack Number DYNJ83732; 44) EXTREMITY PACK, Pack Number DYNJ54684B; 45) EXTREMITY PACK-BELVIDERE, Pack Number DYNJ44692D; 46) EXTREMITY/TRAUMA PACK-LF, Pack Number DYNJ0190688Q; 47) FAIRFIELD KNEE-LF, Pack Number DYNJ30196F; 48) FH PODIATRY PACK-LF, Pack Number DYNJ51796G; 49) FHWC EXTREMITY PACK, Pack Number DYNJ39734D; 50) FOOT AND ANKLE PACK, Pack Number DYNJ65319B; 51) GENERAL ORTHO PACK-LF, Pack Number DYNJ0781892X; 52) GP ARTHROSCOPY KNEE PACK-LF, Pack Number DYNJ0163462Y; 53) GSC KNEE ARTHROSCOPY, Pack Number DYNJ908637; 54) HAND NO SPONGE NOBASIN NOBOWL, Pack Number DYNJ68906; 55) HAND PACK, Pack Number DYNJ44076B; 56) HAND PACK, Pack Number DYNJ60203; 57) HAND PACK, Pack Number DYNJ42329G; 58) HAND PACK, Pack Number DYNJ43386; 59) HAND PACK, Pack Number DYNJ38715C; 60) HAND PACK, Pack Number DYNJ51930A; 61) HAND PACK, Pack Number DYNJ56195C; 62) HAND PACK, Pack Number DYNJ48236I; 63) HAND PACK, Pack Number DYNJ82784; 64) HAND PACK, Pack Number DYNJ55283D; 65) HAND PACK, Pack Number DYNJ44084D; 66) HAND PACK, Pack Number DYNJ46978B; 67) HAND PACK, Pack Number DYNJ81283; 68) HAND PACK, Pack Number DYNJ69908A; 69) HAND PACK XM-LF, Pack Number DYNJ39828D; 70) HAND PACK-LF, Pack Number DYNJ04606G; 71) HAND PACK-LF, Pack Number DYNJ0773815M; 72) HAND PACK-LF, Pack Number DYNJ59960B; 73) HAND/ELBOW PACK, Pack Number DYNJ52097F; 74) HIP PACK, Pack Number DYNJ23762L; 75) HL ACL PACK, Pack Number DYNJ40357C; 76) JOS KNEE PACK, Pack Number PHS977014AK; 77) KNEE ARTH PACK, Pack Number DYNJ83854A; 78) KNEE ARTHROSCOPY, Pack Number DYNJ50313A; 79) KNEE ARTHROSCOPY, Pack Number DYNJ64208; 80) KNEE ARTHROSCOPY PACK, Pack Number DYNJ50682B; 81) KNEE ARTHROSCOPY PACK, Pack Number DYNJ61581A; 82) KNEE ARTHROSCOPY PACK, Pack Number DYNJ41162; 83) KNEE ARTHROSCOPY PACK, Pack Number DYNJ48237J; 84) KNEE ARTHROSCOPY PACK, Pack Number DYNJ39184B; 85) KNEE ARTHROSCOPY PACK, Pack Number D

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·April 2, 2025

    Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) SPINAL ANESTHESIA TRAY-LF, Medline Kit SKU DYNJRA0102A; 2) SPINAL TRAY-LF, Medline Kit SKU DYNJRA0143B; 3) SPINAL PREP TRAY-LF, Medline Kit SKU DYNJRA0205B; 4) SPINAL TRAY, Medline Kit SKU DYNJRA0255B; 5) SPINAL TRAY, Medline Kit SKU DYNJRA0320; 6) SPINAL TRAY, Medline Kit SKU DYNJRA0320A; 7) SPINAL BLOCK TRAY- LF, Medline Kit SKU DYNJRA0413C; 8) SPINAL TRAY, Medline Kit SKU DYNJRA0461D; 9) 25G SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA0945; 10) SPINAL TRAY, Medline Kit SKU DYNJRA1140B; 11) SPINAL TRAY, Medline Kit SKU DYNJRA1192; 12) SPINAL TRAY 25G, Medline Kit SKU DYNJRA1240; 13) TRAY, SPINAL PENCIL POINT 25G, Medline Kit SKU DYNJRA1288; 14) SPINAL 25G WHITACRE, Medline Kit SKU DYNJRA1301; 15) SPINAL BLOCK TRAY WHITACRE 24G, Medline Kit SKU DYNJRA1304; 16) AHN SPINAL TRAY, Medline Kit SKU DYNJRA1376; 17) SPINAL TRAY, Medline Kit SKU DYNJRA1477A; 18) ADULT SPINAL KIT, Medline Kit SKU DYNJRA1538; 19) SPINAL TRAY, Medline Kit SKU DYNJRA1558A; 20) SPINAL TRAY, Medline Kit SKU DYNJRA1560A; 21) SPINAL TRAY, Medline Kit SKU DYNJRA1565; 22) SPINAL ANESTHESIA TRAY, Medline Kit SKU DYNJRA1577C; 23) SPINAL NEEDLE TRAY, Medline Kit SKU DYNJRA1584; 24) 25G WHITACRE SPINAL TRAY, Medline Kit SKU DYNJRA1740A; 25) SPINAL TRAY, Medline Kit SKU DYNJRA1744A; 26) SPINAL TRAY, Medline Kit SKU DYNJRA1750A; 27) SPINAL TRAY, Medline Kit SKU DYNJRA1784; 28) SPINAL TRAY, Medline Kit SKU DYNJRA1790; 29) SPINAL TRAY, Medline Kit SKU DYNJRA1796; 30) MSSC SPINAL TRAY, Medline Kit SKU DYNJRA1802B; 31) SPINAL TRAY, Medline Kit SKU DYNJRA1818; 32) SPINAL TRAY, Medline Kit SKU DYNJRA1839; 33) SPINAL TRAY, Medline Kit SKU DYNJRA1884; 34) SPINAL TRAY, Medline Kit SKU DYNJRA1884A; 35) 24G SPINAL KIT, Medline Kit SKU DYNJRA1889; 36) SPINAL TRAY, Medline Kit SKU DYNJRA1929; 37) SPINAL TRAY, Medline Kit SKU DYNJRA1969; 38) SPINAL TRAY, Medline Kit SKU DYNJRA1982; 39) SPINAL TRAY/PENCAN, Medline Kit SKU DYNJRA1983A; 40) SPINAL NEEDLE TRAY, Medline Kit SKU DYNJRA1987; 41) SPINAL TRAY - 3 ML CHLORAPREP, Medline Kit SKU DYNJRA2005; 42) SPINAL TRAY, Medline Kit SKU DYNJRA2023; 43) SPINAL TRAY, Medline Kit SKU DYNJRA2068A; 44) SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA2088; 45) 25G WHITACRE SPINAL TRAY, Medline Kit SKU DYNJRA2115; 46) SPINAL BLOCK 25G WHTCRE 5S BU, Medline Kit SKU DYNJRA2117; 47) SPINAL TRAY, Medline Kit SKU DYNJRA2140; 48) SPINAL TRAY, Medline Kit SKU DYNJRA2153; 49) SPINAL BLOCK TRAY WHITACRE 24G, Medline Kit SKU DYNJRA2213; 50) SPINAL TRAY, Medline Kit SKU DYNJRA2225; 51) OR SPINAL BLOCK KIT, Medline Kit SKU DYNJRA2349; 52) SPINAL TRAY, Medline Kit SKU DYNJRA2360; 53) L&D SPINAL TRAY, Medline Kit SKU DYNJRA2371; 54) TRAY, 25G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2381; 55) SPINAL TRAY, Medline Kit SKU DYNJRA2432A; 56) OB SPINAL TRAY, Medline Kit SKU DYNJRA2532; 57) SPINAL TRAY, Medline Kit SKU DYNJRA2534; 58) SPINAL TRAY, Medline Kit SKU DYNJRA2556; 59) SPINAL TRAY, Medline Kit SKU DYNJRA2566A; 60) SPINAL TRAY BRAUN, Medline Kit SKU DYNJRA2575; 61) SPINAL TRAY, Medline Kit SKU DYNJRA2592; 62) SPINAL TRAY, Medline Kit SKU DYNJRA2597; 63) SPINAL BLOCK, Medline Kit SKU DYNJRA2605; 64) SPINAL TRAY, Medline Kit SKU DYNJRA2606; 65) SPINAL TRAY, Medline Kit SKU DYNJRA2607; 66) SPINAL TRAY, Medline Kit SKU DYNJRA2607A; 67) SPINAL TRAY, Medline Kit SKU DYNJRA2611; 68) SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA2613; 69) SPINAL TRAY, Medline Kit SKU DYNJRA2618A; 70) SPINAL TRAY, Medline Kit SKU DYNJRA2634; 71) SPINAL TRAY, Medline Kit SKU DYNJRA2638; 72) SPINAL TRAY, Medline Kit SKU DYNJRA2639; 73) JOI SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA2641; 74) SPINAL TRAY, Medline Kit SKU DYNJRA2653; 75) SPINAL BLOCK 25G WHTCRE 5S BU, Medline Kit SKU DYNJRA2669; 76) SPINAL TRAY, Medline Kit SKU DYNJRA2670; 77) SPINAL BLOCK TRAY 18G INTRO, Medline Kit SKU DYNJRA2672; 78) SPINAL TRAY 24G, Medline Kit

    FDA Enforcement
    Class I ·Ongoing·Medline Industries, LP·June 3, 2026