BEUDAMED
    21 results · 29ms · Sources: EU EUDAMED, US FDA

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    MOBICATH TRANSSEPTAL NEEDLE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NA

    FDA UDI
    MAKO SURGICAL CORP.·00848486029487·KNEE FEMORAL CHECKPOINT

    Bone cutters

    FDA UDI
    DFS - DIAMON GmbH·04057176148117·Bone Cutter type 164 CA

    QUANTA FLASH H-TTG IGG

    FDA 510(k)
    FDA Class 2 ·Immunology

    PRAEZIS PLUS

    FDA 510(k)
    FDA Class 2 ·Neurology

    SEDLINE KIT

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code MWI·December 7, 2017

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 8, 2025

    SEDLINE KIT

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code MWI·January 8, 2017

    TURBO-JECT® SINGLE LUMEN POWER-INJECTABLE PICC

    FDA Adverse Event
    Injury ·COOK INC·Product code LJS·January 18, 2017

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 14, 2013

    LIGAMAX - CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·June 2, 2011

    ITREL 3

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·August 13, 2008

    TURBO-JECT POWER INJECTABLE

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LJS·July 3, 2018

    SEDLINE KIT

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code GWQ·July 21, 2017

    TURBO-JECT STANDARD POWER INJECTABLE PICC LINE PICC

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LJS·August 24, 2017

    1820334-2020-01805

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FOZ·October 5, 2020

    TURBO-JECT STANDARD POWER INJECTABLE PICC LINE PICC

    FDA Adverse Event
    Injury ·COOK INC·Product code LJS·June 28, 2018

    CollaCote Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corporation·May 22, 2013

    Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERILE EO

    FDA Enforcement
    Class I ·Ongoing·Abbott Vascular·May 25, 2022

    SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM go.All 11061630 & 11061638 SOMATOM go.Top 11061640 & 11061648 SOMATOM go.Sim 11061660 & 11061668 SOMATOM go.Open Pro 11061670 & 11061678 SOMATOM X.cite 11330001 Intended Use: Computed tomography x-ray system

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022