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

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    KLS Martin IPS Preprosthetic

    FDA 510(k)
    FDA Class 2 ·Dental

    DG Gel 8 Rh Pheno

    FDA UDI
    DIAGNOSTIC GRIFOLS SA·08436583731093·The DG Gel 8 Rh Pheno card is for the determina...

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319706893·Silver Osteotome 7" (17.5cm), single guard, right

    GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    NIDEK MULTICOLOR LASER PHOTOCOAGULATOR

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    ONE TOUCH ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code NBW·October 20, 2008

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·July 11, 2011

    ENDOTAK RELIANCE

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code NVY·July 8, 2013

    TRUEMETRIX

    FDA Adverse Event
    Malfunction ·TRIVIDIA HEALTH, INC.·Product code NBW·August 7, 2019

    Synchro2, 0.014in x 200cm STANDARD Guidewire with Hydrophilic Coating, UPN Product No. M00326410, REF 2641, STERILE: EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures.

    FDA Enforcement
    Class II ·Terminated·Stryker Neurovascular·November 6, 2019

    SEARCH-CYTE TCS 0.8%

    FDA Adverse Event
    Malfunction ·MEDION GRIFOLS DIAGNOSTICS AG,·Product code QHT·July 2, 2025

    SEARCH-CYTE PLUS 0.8%

    FDA Adverse Event
    Malfunction ·MEDION GRIFOLS DIAGNOSTICS AG,·Product code QHT·September 18, 2025

    Synchro2, 0.014in x 300cm SOFT Guidewire with Hydrophilic Coating , UPN Product No. M00326310, REF 2631, STERILE:EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures.

    FDA Enforcement
    Class II ·Terminated·Stryker Neurovascular·November 6, 2019

    NexGenTrabecular Metal Tibial Half Block Augment, Left Lateral/Right Medial, Size 4 5MM Thickness W/Screws Item Number: 00544800436 Product Usage: The Trabecular Metal Tibial Cone Augments are intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates total knee arthroplasty. When used with the NexGen Complete Knee Solution Rotating Hinge Knee (RHK) System, the Trabecular Metal Tibial Cone Augments are for cemented use only. When used with the NexGen Complete Knee Solution Legacy Constrained Condylar Knee System, the Trabecular Metal Tibial Cone Augments are for cementless or cemented use.

    FDA Enforcement
    Class II ·Terminated·Zimmer Trabecular Metal Technology, Inc.·March 20, 2019

    SEARCH-CYTE PLUS 0.8%

    FDA Adverse Event
    Malfunction ·MEDION GRIFOLS DIAGNOSTICS AG,·Product code QHT·May 19, 2026

    SEARCH-CYTE TCS 0.8%

    FDA Adverse Event
    Malfunction ·MEDION GRIFOLS DIAGNOSTICS AG,·Product code QHT·April 3, 2025

    Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter Inc.·October 13, 2021

    Synchro2, 0.014 in x 200cm, SOFT Guidewire with Hydrophilic Coating, UPN Product No. M00326010 REF 2601, STERILE: EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures.

    FDA Enforcement
    Class II ·Terminated·Stryker Neurovascular·November 6, 2019

    NexGenTrabecular Metal Tibial Half Block Augment, Right Lateral/Left Medial, Size 4 5MM Thickness W/Screws Item Number: 00544800426 Product Usage: The Trabecular Metal Tibial Cone Augments are intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates total knee arthroplasty. When used with the NexGen Complete Knee Solution Rotating Hinge Knee (RHK) System, the Trabecular Metal Tibial Cone Augments are for cemented use only. When used with the NexGen Complete Knee Solution Legacy Constrained Condylar Knee System, the Trabecular Metal Tibial Cone Augments are for cementless or cemented use.

    FDA Enforcement
    Class II ·Terminated·Zimmer Trabecular Metal Technology, Inc.·March 20, 2019

    BARD MAX-CORE Disposable Core Biopsy Instrument - Product Usage: The core needle biopsy device is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.

    FDA Enforcement
    Class II ·Terminated·Bard Peripheral Vascular Inc·January 1, 2020