BEUDAMED
    17 results · 24ms · Sources: EU EUDAMED, US FDA

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    COULTER 6C CELL CONTROL, MODELS 628027 & A59925

    FDA 510(k)
    FDA Class 2 ·Hematology

    ComfortGel Blue

    FDA UDI
    Respironics, Inc.·00606959013889·ComfortGel Blue Full Mask, Large, International

    Ormco

    FDA UDI
    ORMCO CORPORATION·00889989026795·ARCH P/F EDG.RECT.UP180 X220 PK10

    PIT AND FISSURE CHEMICAL CURING SEALANT

    FDA 510(k)
    FDA Class 2 ·Dental

    THE V-BAG

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Biliary Plastic Stent Set

    FDA UDI
    Micro-Tech (Nanjing) Co., Ltd.·06932503514071·TPU,Side bend,8.5Fr,18cm working length with 22...

    Biliary Plastic Stent Set/ short-wire compatible

    FDA UDI
    Micro-Tech (Nanjing) Co., Ltd.·06932503514828·TPU,Side bend,8.5Fr,18cm working length with 22...

    Biliary Plastic Stent Set

    FDA UDI
    Micro-Tech (Nanjing) Co., Ltd.·06932503514316·TPU,Center bend,8.5Fr,18cm working length with ...

    Biliary Plastic Stent Set/ short-wire compatible

    FDA UDI
    Micro-Tech (Nanjing) Co., Ltd.·06932503515009·TPU,Center bend,8.5Fr,18cm working length with ...

    Biliary Plastic Stent Set

    FDA UDI
    Micro-Tech (Nanjing) Co., Ltd.·06932503515689·TPU,Straight,8.5Fr,18cm working length with 220...

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FPA·April 29, 2013

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 9, 2011

    PUMP MMT-722NAS PRDGM INS V2.2 SK EN

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·July 23, 2008

    CANNULA & CATHETER

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY GMBH·Product code DWF·April 22, 2025

    Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701, and 702 modules; and cobas e 602 and 801 modules). Chemistry Analyzer (photometric discrete), for clinical use Part Number: 08763662001

    FDA Enforcement
    Class II ·Ongoing·Roche Diagnostics Operations, Inc.·January 6, 2021

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018