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

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

    Peri-Guard Repair Patch, Product Codes: a) PC1016NBIO: 10X16CMUS, b) PC1225NBIO: 12X25CMUS, c) PC0404NBIO: 4X4CMUS, d) PC0608NBIO: 6X8CMUS, e) PC0814NBIO: 8X14CMUS

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·January 17, 2024

    Peri-Guard Repair Patch, Product Codes: a) PG1016 : 10 X 16 CMUS, TS b) PG1225: 12 X 25 CMUS, TS c) PG0404: 4 X 4 CMUS, TS d) PG0608: 6 X 8CMUS, TS e) PG0814: 8 X 14 CMUS, TS

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·January 17, 2024

    Vascu-Guard Peripheral Vascular Patch (US), Product Codes: a) VG0108: 0.8 X 8 CM US, TS; b) VG0110: 1 X 10 CM US, TS; c) VG0106: 1 X 6 CM US, TS; d) VG0209: 2 X 9 CM US, TS

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·January 17, 2024

    PERI-GUARD SUPPLE, Product Codes: a) SPG1016: 10X16 CM US, TS; b) SPG0404: 4 X 4 CM US, TS; c) SPG0608: 6 X 8 CM US, TS; d) SPG0814: 8 X 14 CM US, TS; e) PC1016SNBIO: 10X16 CM US; f) PC0404SNBIO: 4X4 CM US; g) PC0608SNBIO: 6X8 CM US; h) PC0814SNBIO: 8X14 CM US

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·January 17, 2024

    Baxter Vascular Probe, Product Codes: a) 7081015: 8CM, 1- 1.5 MM GLOBAL, b) 7081520: 8CM, 1.5-2 MM GLOBAL, c) 7082025: 8CM, 2-2.5 MM GLOBAL, d) 7151015: 15CM, 1-1.5 MM GLOBAL, e) 7151520: 15CM, 1.5- 2 MM GLOBAL, f) 7152025: 15CM, 2- 2.5 MM GLOBAL, g) 7451015: 45CM, 1- 1.5 MM GLOBAL, h) 7451520: 45CM, 1.5- 2 MM GLOBAL, i) 7452025: 45CM, 2- 2.5 MM GLOBAL, j) 7081015ES: 8CM, 1-1.5 MM GLOBAL, k) 7081520ES: 8CM, 1.5- 2 MM GLOBAL, l) 7082025ES: 8CM, 2-2.5 MM GLOBAL, m) 7151015ES: 15CM, 1-1.5 MM GLOBAL, n) 7151520ES: 15CM, 1.5- 2 MM GLOBAL, o) 7152025ES: 15CM, 2-2.5 MM GLOBAL, p) 7451015ES: 45CM, 1-1.5 MM GLOBAL, q) 7451520ES: 45CM, 1.5-2 MM GLOBAL, r) 7452025ES: 45CM, 2-2.5 MM GLOBAL

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·January 17, 2024

    Baxter Flo-Rester, Disposable internal vessel occluder, distributed in the following sizes: a) Product Code 50100: 12MM, 1.00 MM GLOBAL; b) Product Code 50150: 12MM, 1.50 MM GLOBAL; c) Product Code 50175: 12MM, 1.75 MM GLOBAL; d) Product Code 50200: 12MM, 2.00 MM GLOBAL; e) Product Code 50225: 12MM, 2.25 MM GLOBAL; f) Product Code 50250: 12MM, 2.50 MM GLOBAL; g) Product Code 50275: 12MM, 2.75 MM GLOBAL; h) Product Code 50300: 12MM, 3.00 MM GLOBAL; i) Product Code 50350: 12MM, 3.50 MM GLOBAL; j) Product Code 50400: 12MM, 4.00 MM GLOBAL; k) Product Code 60100: 30MM, 1.00 MM GLOBAL; l) Product Code 60175: 30MM, 1.75 MM GLOBAL; m) Product Code 60275: 30MM, 2.75 MM GLOBAL; n) Product Code 60300: 30MM, 3.00 MM GLOBAL; o) Product Code 60350: 30MM, 3.50 MM GLOBAL; p) Product Code 50125: 12MM, 1.25 MM GLOBAL; q) Product Code 50450BIOS: 12MM, 4.50 MM GLOBAL; r) Product Code 60125BIOS: 30MM, 1.25 MM GLOBAL; s) Product Code 60150BIOS: 30MM, 1.50 MM GLOBAL; t) Product Code 60200BIOS: 30MM, 2.00 MM GLOBAL; u) Product Code 60225BIOS: 30MM, 2.25 MM GLOBAL; v) Product Code 60250BIOS: 30MM, 2.50 MM GLOBAL; w) Product Code 60400BIOS: 30MM, 4.00 MM GLOBAL; x) Product Code 60450BIOS: 30MM, 4.50 MM GLOBAL

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·January 17, 2024

    BD Pyxis Product Name / UDI-DI code / Catalog No. BD Pyxis" MedStation" 4000 Main / 10885403512629 / 303 BD Pyxis" MedStation" ES Tower / 10885403512674 / 352 BD Pyxis" Anesthesia Station ES / 10885403477836 / 327 BD Pyxis" MedStation" ES (Main) / 10885403512667 / 323 BD Pyxis" CII Safe ES / 10885403512605 / 1116-00 BD Pyxis" Enterprise Server / 10885403518348 and 10885403520341 / 1115-00 BD Pyxis" CIISafe, V9.X, SGL IM, BIO, / 10885403512520 / 111-221 BD Pyxis" CIISafe, V7.X, DBL INTG MAIN, BIO, SOLID DO / N/A / 111-194 BD Pyxis" MedBank Tower / 10885403512568 / 169-29 BD Pyxis" CIISafe, V8.X Desktop PC, Bio / N/A / 107-245-01 Supply Server / N/A / N/A CCE Enterprise SW Site License (2-5) / N/A / N/A BD Pyxis" Logistics / N/A / 806 BD Pyxis" SupplyStation" V9 / N/A / 317 Security Module / N/A / 139698-01 Supply itParActive RF V11 / N/A / 138566-01 BD Knowledge Portal for Medication Technologies / N/A / 136607-01 STOCKSTN V10.X WRD/WL SCANNERS / N/A / 132-53-02 PRS STOCKSTN V10.X WRD/WL SCANNERS / N/A / 132-53-01 STOCKSTN V10.X WIRED SCANNER / N/A / 132-52-02 PRS STOCKSTN V10.X WIRED SCANNER / N/A / 132-52-01 BD Pyxis" CII Safe ES, Desktop PC / N/A / 1156-00 BD Pyxis" SupplyStation" Panel PC V11 / N/A / 1132-00 Pyxis" SupplyRoller V11 / N/A / 1127-00 Dell 640 Server / N/A / 1128-00 BD Pyxis" SupplyStation" System V11 / N/A / 1123-00 BD Pyxis" SupplyRoller V10 / N/A / 1101-00 BD Pyxis" SupplyStation" System V10 / **** / 347 BD Pyxis CII Safe,V9.X DESKTOP PC / **** / 107-252-01 BD Pyxis CII Safe,V7.X,DBL INTG MAIN,BIO,CLEAR DO 111-191 BD Pyxis CII Safe, V9.X, DBL IM, BIO, SLD DOORS / **** / 111-215 BD Care Coordination Engine (CCE) / **** / 134056-01 The Pyxis devices are automated medication dispensing cabinet that is intended to securely store and dispense medications to a qualified and authorized healthcare provider.

    FDA Enforcement
    Class II ·Ongoing·CareFusion 303, Inc.·September 3, 2025

    3mensio Workstation (Vascular Fenestrated) software

    FDA Enforcement
    Class II ·Ongoing·PIE Medical Imaging B.V.·August 20, 2025

    ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation Therapy, Radiology, or Radiology image-guided treatment environment. Part Number: 1SOPT00003

    FDA Enforcement
    Class II ·Ongoing·LEONI CIA CABLE SYSTEMS·November 29, 2023

    ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation Therapy, Radiology, or Radiology image-guided treatment environment. Part Number: 1SOPT00009

    FDA Enforcement
    Class II ·Ongoing·LEONI CIA CABLE SYSTEMS·November 29, 2023

    Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-BW1; (2) Arrow Arterial Access Tray with 0.021" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-CK; (3) Arrow Arterial Access Kit, .025 inch dia. spring-wire guide, REF ASK-04001-VAMC1; (4) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-BHS; (5) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .025 inch dia. spring-wire guide, REF ASK-04020-BID; (6) Arrow Arterial Line Kit, 20 Ga., 12 cm. catheter length, .025 inch dia. spring-wire guide, REF ASK-04020-HMC; (7) Arrow Arterial Catheterization Kit, 20 Ga. 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-HOA; (8) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm. catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-KSD; (9) Arrow Arterial Catheterization Kit, 20 Ga. 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-LOL; (10) Arrow Radial Catheterization, 20 Ga. 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-MHS; (11) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, 018 inch dia. spring-wire guide, REF ASK-04020-MIB3; (12) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .018 dia. spring- wire guide, REF ASK-04020-PRH; (13) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .018 dia. spring-wire guide, REF ASK-04020-UOIL; (14) Arrow QuickFlash Radial Artery Catheterization Kit, 20 Ga., 3.81 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04220-KSP; and (15) Arrow Arterial Catheterization Kit, 20 Ga. 4.45/12 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04500-HFH4.

    FDA Enforcement
    Class II ·Ongoing·ARROW INTERNATIONAL Inc.·October 2, 2024

    CMV IgM EIA, in vitro diagnostic.

    FDA Enforcement
    Class II ·Ongoing·Bio-Rad Laboratories, Inc.·December 7, 2022

    Total Thyroxine (T4) ELISA; REF EIA-1781

    FDA Enforcement
    Class II ·Ongoing·DRG International, Inc.·December 8, 2021

    HYTEC Stop Solution (Allergy), 300ml bottle containing 1N sodium hydroxide solution, Part # 308051, sold separately or as a component contained in the following kits: (1) HYTEC Specific/Total IgE EIA kit, Part# 74155; and (2) HYTEC Specific IgG EIA Kit, Part# 74114.

    FDA Enforcement
    Class II ·Ongoing·Hycor Biomedical LLC·November 6, 2019

    Parvovirus B19 IgG EIA kit Part No. V519IGUS

    FDA Enforcement
    Class II ·Ongoing·Diasorin Inc.·September 9, 2020

    Guide Wire with Ruler Tube 3x800 mm DIA; Catalog number/REF: 2351-3080S;

    FDA Enforcement
    Class II ·Ongoing·Stryker GmbH·April 23, 2025

    Guide Wire with Ruler Tube 3x1000 mm DIA; Catalog number/REF: 2351-3100S;

    FDA Enforcement
    Class II ·Ongoing·Stryker GmbH·April 23, 2025

    TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 Product Description: Stapes Prosthesis

    FDA Enforcement
    Class II ·Ongoing·Grace Medical, Inc.·June 10, 2026

    Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 12 mm, Product Code: 880-601/12

    FDA Enforcement
    Class II ·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·March 26, 2025

    Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 11 mm, Product Code: 880-601/11

    FDA Enforcement
    Class II ·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·March 26, 2025