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

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    Filters Classification: Class Ii × Status: Ongoing × Clear all

    Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER SLEEVE Model/Catalog Number: 804-06-310 Product Description: Material: S.S/CoCrMo, Non-Sterile

    FDA Enforcement
    Class II ·Ongoing·Encore Medical, LP·September 17, 2025

    Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER BOSS DRILL, 6.5mm Model/Catalog Number: 804-06-312 Product Description: Material: S.S., Non Sterile

    FDA Enforcement
    Class II ·Ongoing·Encore Medical, LP·September 17, 2025

    Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER HEAD Model/Catalog Number: 804-06-311 Product Description: Material: S.S/Nitronic, Non-Sterile

    FDA Enforcement
    Class II ·Ongoing·Encore Medical, LP·September 17, 2025

    Myosa for Kids KS1 REF MyOSAKS1_Sb/Sp/Mb/Mp/Lb/Lc KS2 REF MyOSAKS2_Sb/Sc/Mb/Mc/Mp/Lb/Lc Myosa for Kids is a mouthguard in 3 different sizes (sm, med, lg) that can be used in children ages 3-15 to address breathing and myofunctional disorders. Catalog Numbers:

    FDA Enforcement
    Class II ·Ongoing·Myofunctional Research Company USA·December 24, 2025

    Medline Convenience Kits: 1) DRAPE PACK, Model Number: DYNJ35363A; 2) SICK KIDS-GENERAL CUSTOM SPLIT, Model Number: SPTPCD10005

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·February 25, 2026

    Medline Convenience Kits: 1) DRAPE PACK, Model Number: DYNJ35363A; 2) SICK KIDS-GENERAL CUSTOM SPLIT, Model Number: SPTPCD10005

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·May 13, 2026

    medex TranStar KIDS KIT 31IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9544

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·October 30, 2024

    medex TranStar KIDS KIT 34IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9545

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·October 30, 2024

    medex TranStar KIDS KIT 10IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9548

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·October 30, 2024

    medex TranStar KIDS KIT 19IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9543

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·October 30, 2024

    medex TranStar KIDS KIT 7INCH CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9547

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·October 30, 2024

    namic CONVENIENCE KIT, a) CAROTID MANIFOLD KIT, REF 60011045; b) 3V MANIFOLD KIT ON WITH NAMIC DT & WASTE MANAGEMENT, REF 60070582; c) LEFT HEART KIT, REF 60071822; d) LEFT HEART KIT, REF 60080085; e) CONVENIENCE KIT, REF 60100055; f) CONVENIENCE KIT, REF 60101041; g) CONVENIENCE KIT, REF 60120336; h) LEFT HEART KIT, REF 60131446; i) 3 VALVE MANIFOLD OFF KIT WITH SQUEEZE CONTRAST CONTROLLER AND PROTECTION STATION, REF 60140798; j) CONVENIENCE KIT, REF 60142592; k) LEFT HEART KIT, REF 60183972; l) FOUR VALVE MANIFOLD KIT, REF 60210209; m) RIGHT HEART KIT, REF 60210862; n) LEFT HEART KIT, REF 600705710; o) CONVENIENCE KIT, REF 600803410; p) TUBING KIT; REF 601322913; q) LEFT HEART KIT, REF 60032582A

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·May 22, 2024

    Firefly Floorsitter, Firefly Splashy Bathseat, Firefly GoTo Seat - Product Usage: The Splashy Bath-Seat is a Portable bath seat for children aged 1-8, The GoTo Seat is a light-weight, portable, postural support seat for kids, aged between 1 and 8 with disabilities.

    FDA Enforcement
    Class II ·Ongoing·James Leckey Design Ltd·April 15, 2020

    CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter Mishima K.K.·March 18, 2026

    DxC 700 AU, REF: B86444, B86446

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter Mishima K.K.·March 18, 2026

    DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only.

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter Mishima K.K.·August 7, 2024

    DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only.

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter Mishima K.K.·August 28, 2024

    Brand Name: DJO SURGICAL Product Name: FA S Altivate Reverse Glenoid Tray Model/Catalog Number: None Software Version: NA Product Description: Enovis" shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the Indication for use. While total shoulder replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients. The AltiVate Reverse¿ Shoulder Prosthesis is indicated as a reverse shoulder replacement for patients with a functional deltoid muscle and a grossly deficient rotator cuff joint suffering from pain and dysfunction due to: " Severe arthropathy with a grossly deficient rotator cuff; " Previously failed joint replacement with a grossly deficient rotator cuff; " Fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder including humeral head fracture, displaced 3- or 4-part fractures of proximal humerus, or reconstruction after tumor resection; " Bone defect in proximal humerus; " Non-inflammatory degenerative disease including osteoarthritis and avascular necrosis of the natural humeral head and/or glenoid; " Inflammatory arthritis including rheumatoid arthritis; " Correction of functional deformity. The glenoid baseplate is intended for cementless application with addition of screws for fixation. This device may also be indicated in the salvage of previously failed surgical attempts for anatomic and hemi procedures. All RSP¿ Monoblock and AltiVate Reverse¿ humeral stems are intended for cemented or cementless use. Enovis" instrumentation consists of devices and their accessories used in surgical procedures. Implantation of Enovis" products should only be performed with Enovis" instrumentation or instrumentation distributed by Enovis". Enovis" instruments and instrument cases are generally composed of titanium, stainless steel, aluminum, and/or polymeric materials. The cases may be multi-layered with various inserts to hold surgical instrumentation in place during handling and storage. The inserts may consist of trays, holders, and silicone mats. The instrument cases will allow sterilization of the contents to occur in a steam autoclave utilizing the cleaning, sterilization, and drying cycle that has been validated and detailed below. Instrument cases do not provide a sterile barrier and must be used in conjunction with FDA cleared sterilization wrap to maintain sterility. Instruments are provided non-sterile and should be stored in their original packaging until cleaned and sterilized according to the recommended guidelines listed below. Component: NA

    FDA Enforcement
    Class II ·Ongoing·Encore Medical, LP·September 17, 2025

    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. MULTI-LUMEN CVC BUNDLE KIT, Model Number: ECVC475; b. MULTI-LUMEN CVC INSERTION BUNDLE, Model Number: ECVC3900; c. MULTIMED 16G 1L 20CM CVC STOCK+BUNDLE US, Model Number: STCVC20US; d. MULTIMED 7F 2L 16CM STOCK + BUNDLE US, Model Number: STCVC21US; e. MULTIMED 7F 3L 16CM CVC BUNDLE, Model Number: ECVC6585A; f. MULTIMED 7F 3L 20CM PI, Model Number: ECVC7235A; g. MULTIMED 7FR 16CM CVC STK + BUNDLE-US, Model Number: STCVC03US; h. MULTIMED 7FR 3L 16CM CVC BUNDLE, Model Number: ECVC6655A; i. MULTIMED 7FR 3L 20CM CVC BUNDLE-US, Model Number: ECVC7935; j. MULTIMED 7FR 3L 20CM CVC STK + BUNDLE-US, Model Number: STCVC04US; k. MULTIMED 7FR, 20CM, 3L CVC BUNDLE, Model Number: ECVC7670; l. MULTIMED 8.5F 20CM QUAD CVC BUNDLE, Model Number: ECVC7090; m. MULTIMED 8.5FR 16CM QUAD CVC BUNDLE, Model Number: ECVC6930; n. MULTIMED 8.5FR 2L 16CM CVC STK+BUNDLE-US, Model Number: STCVC13US; o. NEURO CATH PACK (NCLUA)227-LF, Model Number: DYNJ47646D, DYNJ47646F, DYNJ47646G, DYNJ47646I; p. O.R. DOUBLE LUMEN INSERTION TRAY, Model Number: ECVC8010; q. OLEAN GENERAL CVC BUNDLE, Model Number: ECVC4615; r. OR ANGIO PACK, Model Number: DYNJ59184B; s. OR ANGIOGRAM, Model Number: DYNJ909267; t. OR ANGIOGRAPHY DRAPE, Model Number: DYNJ906297D; u. OR ANGIOGRAPHY PACK, Model Numbers: DYNJ67245A, DYNJ67245B; v. OR PERCUTANEOUS CATH PACK, Model Number: DYNJ63372A, DYNJ63372B, DYNJ63372C, DYNJ63372D; w. OR VANTEX 7FR 3L 16CM CVC, Model Number: ECVC6665; x. OR VASCULAR ANGIO PACK, Model Number: DYNJ69763, DYNJ69763A; y. PACK CARDIAC CATH, Model Number: DYNJ65481; z. PACK PERCUTANEOUS ANGIO CHRG, Model Number: DYNJ60112B; aa. PEDIATRIC CATH ANGIO PACK, Model Number: DYNJ54755G, DYNJ54755I; bb. PEDIATRIC CATH PACK-LF, Model Number: DYNJ0843244K; cc. PERCUTANEOUS ANGIO PACK-LF, Model Number: DYNJ57645C; dd. PERCUTANEOUS PACK, Model Number: DYNJ46035C, DYNJ46035D; ee. PERMA CATH PACK, Model Number: DYNJ62007A; ff. PI CVC BUNDLE, VANTEX 3L, 16CM, Model Number: ECVC3665; gg. PI CVC BUNDLE, VANTEX 3L, 20CM, Model Number: ECVC6190; hh. PI VANTEX 7FR 16CM 3L CVC BUNDLE-MAXPLUS, Model Number: ECVC4380; ii. PI VANTEX 7FR 16CM 3L CVC-MicroClave, Model Number: ECVC5655; jj. PI VANTEX 7FR 20CM 3L CVC-MicroClave, Model Number: ECVC5650; kk. PI VANTEX 8.5FR 16CM 4L CVC-MicroClave, Model Number: ECVC5660; ll. PI VANTEX 8.5FR 20CM 4L CVC-MicroClave, Model Number: ECVC5685; mm. PICC LINE PACK-LF, Model Number: DYNJ0275614F; nn. PK, RADIOLOGY, Model Number: DYNJ43894B; oo. PORT A CATH PACK, Model Number: DYNJ59307F; pp. PORT PACK, Model Number: DYNJ58162; qq. PORTACATH PACK, Model Number: DYNJ51240A; rr. QUAD LUMEN CVC BUNDLE 8.5F, 16CM, Model Number: ECVC3700; ss. QUAD LUMEN CVC BUNDLE, 8.5F, 20CM, Model Number: ECVC4995; tt. QUAD LUMEN CVC INSERTION BUNDLE, Model Numbers: ECVC5025, ECVC4135; uu. QUAD LUMEN KIT, Model Number: ECVC5820; vv. RADIOFREQUENCY ABLATION PACK, Model Number: DYNJ65913; ww. RADIOLOGY PACK, Model Numbers: DYNJ41190, DYNJ43894A, DYNJ44087A, DYNJ44524F, DYNJ52806C; xx. RADIOLOGY PACK 108402-LF, Model Number: DYNJVB1000; yy. RR-ADULT ECMO PACK, Model Number: DYNJ69742, DYNJ69742B; zz. SHEATH INTRODUCER BUNDLE, Model Number: ECVC2930, ECVC5835; aaa. SK-ANGIO TRAY-LF, Model Number: DYNJ82030; bbb. SK-INTERVENTIONAL TRAY-LF, Model Number: DYNJ82041; ccc. SPECIAL PROCEDURE CATH LAB PK, Model Number: DYNJ68729; ddd. SPECIAL PROCEDURE PACK, Model Number: DYNJ38314G; eee. SPECIAL PROCEDURE PACK-LF, Model Number: DYNJ0416535AA, DYNJ0416535W, DYNJ0458661C; fff. SPECIAL PROCEDURE PK-LF, Model Number: DYNJ0604508R; ggg. SPECIAL PROCEDURES, Model Number: DYNJ23288C; hhh. STANDARD ANGIO TRAY MV, Model Number: DYNJ67136A; iii. STD, AVA ,3XI ,3L 8.5F KIC, Model Number: ECVC7465A; jjj. STD, AVA, 3L, 9F, HF, KIC, Model Number: ECVC810

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

    REF: 126590, MEDLINE, STERILE ULTRASOUND GEL, 0.70 FL oz. (20 mL), QTY: 50, STERILER, CE 2292

    FDA Enforcement
    Class II ·Ongoing·Turkuaz Saglik Hizmetleri Medikal Temizlik Kim. Ur. San. ve Tic. A.S.·January 31, 2024