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

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

    Arrow Arterial Catherization Kit-20 Ga. x 4.45 cm Radiopaque Polyurethane over 22 Ga. TW Introducer Needle with Integral .018" (0.46 mm) dia. Spring-Wire Guide Product Code: ASK-04020-PMC The Arrow¿ Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels.

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

    Dimension Tacrolimus (TAC) Flex reagent cartridge-In vitro diagnostic test for the quantitative measurement of tacrolimus in human whole blood on the Dimension¿ clinical chemistry system SMN: 10700795 (DF207)

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics, Inc.·March 22, 2023

    CARESCAPE Central Station (CSCS) V2, Model numbers 2082278-001 and 2082279-001. Update 3/10/2023: The following FRU and display part numbers have been added as affected devices: (1) Part #2082294-001, FRU MP200 POWER SUPPLY ASSEMBLY; (2) Part #2082293-002-R, FRU MP200 CPU ASSEMBLY; (3) Part #2082293-002, FRU MP200 CPU ASSEMBLY; (4) Part #2071523-001, MP200 22 IN DISPLAY WITH TOUCH; (5) Part #2092930-001, DSP LCD 22 IN MED W/TCH W/DKST N AMR; (6) Part #2092930-002, DSP LCD 22 IN MED W/TCH W/DKST BRIT P/C; (7) Part #2092930-003, DSP LCD 22IN MED W/TCH W/DKST EURO P/C; (8) Part #2092930-004, DSP LCD 22IN MED W/TCH W/DKST ITA P/C; (9), Part #2092930-005, DSP LCD 22IN MED W/TCH W/DKST INDIAN P/C; (10) Part #2092930-006, DSP LCD 22IN MED W/TCH W/DKST ISREAL P/C; (11) Part #2092930-007, DSP LCD 22IN MED W/TCH W/DKST SWISS P/C; (12) Part #2092930-008, DSP LCD 22IN MED W/TCH W/DKST AUSTRL P/C; (13) Part #2092930-009, DSP LCD 22IN MED W/TCH W/DKST JPN; (14) Part #2092930-010, DSP LCD 22IN MED W/TCH W/DKST BRZL P/C; (15) Part #2092930-011, DSP LCD 22IN MED W/TCH W DKST ARGNT P C; (16) Part #2092930-012, DSP LCD 22IN MED W TCH W DKST DENMARK; (17) Part #2092930-013, DSP LCD22IN MED W TCH W DKST S AFRICA P C; and (18) Part #2092930-014, DSP LCD22IN MED W TCH W DKST CHINA P C.

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare, LLC·June 22, 2022

    Radiography 7300 C; Model Number: 712037;

    FDA Enforcement
    Class II ·Ongoing·Philips Medical Systems DMC GmbH·November 19, 2025

    CombiDiagnost PCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose.

    FDA Enforcement
    Class II ·Ongoing·Philips Medical Systems Gmbh, DMC·February 26, 2020

    CombiDiagnost GCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose.

    FDA Enforcement
    Class II ·Ongoing·Philips Medical Systems Gmbh, DMC·February 26, 2020

    DigitalDiagnost 4 Flex / Value. radiography and fluoroscopy system

    FDA Enforcement
    Class II ·Ongoing·Philips Medical Systems DMC GmbH·July 20, 2022

    ProxiDiagnost N90. radiography and fluoroscopy system

    FDA Enforcement
    Class II ·Ongoing·Philips Medical Systems DMC GmbH·July 20, 2022

    CombiDiagnost R90 Software Version R1.0 and R1.1

    FDA Enforcement
    Class II ·Ongoing·Philips Medical Systems Gmbh, DMC·September 8, 2021

    DigitalDiagnost 4 High Performance. radiography and fluoroscopy system

    FDA Enforcement
    Class II ·Ongoing·Philips Medical Systems DMC GmbH·July 20, 2022

    DigitalDiagnost C90 High Performance. radiography and fluoroscopy system

    FDA Enforcement
    Class II ·Ongoing·Philips Medical Systems DMC GmbH·July 20, 2022

    DigitalDiagnost C90 Flex/Value/Chest/ER. radiography and fluoroscopy system

    FDA Enforcement
    Class II ·Ongoing·Philips Medical Systems DMC GmbH·July 20, 2022

    CombiDiagnost R90; Model Number: 709031;

    FDA Enforcement
    Class II ·Ongoing·Philips Medical Systems DMC GmbH·November 19, 2025

    DigitalDiagnost 4 (1) High Performance, (2) Flex/Value; Model Number: (1) 712031, (2) 712032;

    FDA Enforcement
    Class II ·Ongoing·Philips Medical Systems DMC GmbH·November 19, 2025

    Precision CRF; Model Number: 706400;

    FDA Enforcement
    Class II ·Ongoing·Philips Medical Systems DMC GmbH·November 19, 2025

    ProxiDiagnost N90; Model Number: 706110;

    FDA Enforcement
    Class II ·Ongoing·Philips Medical Systems DMC GmbH·November 19, 2025

    DigitalDiagnost C90 (1) High Performance, (2) Flex/Value/Chest/ER; Model Number: (1) 712034, (2) 712035;

    FDA Enforcement
    Class II ·Ongoing·Philips Medical Systems DMC GmbH·November 19, 2025

    Custodiol HTK Solution, 500ml bottle. 10 per carton.

    FDA Enforcement
    Class II ·Ongoing·Dr Franz Koehler Chemie Gmbh·October 2, 2024