BEUDAMED
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    ULTRA Telescopes

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    PALACOS®

    FDA UDI
    Heraeus Medical GmbH·04260102135338·The PALACOS® MV pro system consists of a mixing...

    HNM Women Care

    FDA UDI
    HNM STAINLESS, LLC.·00812171027966·PESSARY, CUP #2, W/SUPPORT, 60/28mm

    TRIAL CABLE RETENTION CLIP

    FDA 510(k)
    FDA Class 2 ·Neurology

    INFINITAS MINI-IMPLANT MODEL: DB10-0009, DB10-0010,DB10-0012,DB10-0015,DB10-0016

    FDA 510(k)
    FDA Class 2 ·Dental

    VITAL-PORT ATTACHED SILICONE CATHETER WITH INT TITANIUM POWER INJECTABLE PORT

    FDA Adverse Event
    Injury ·COOK VASCULAR INC·Product code LJT·January 7, 2016

    IMPAX CV REPORTING

    FDA Adverse Event
    Malfunction ·AGFA HEALTHCARE CORP.·Product code LLZ·June 6, 2013

    FEMORAL NAIL, A/R 9X280 MM

    FDA Adverse Event
    Injury ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·June 23, 2011

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 8, 2014

    VITAL-PORT ATTACHED SILICONE CATHETER WITH INT TITANIUM POWER INJECTABLE PORT

    FDA Adverse Event
    Malfunction ·COOK VASCULAR INC·Product code LJT·January 3, 2019

    VITAL-PORT ATTACHED SILICONE CATHETER WITH INT TITANIUM POWER INJECTABLE PORT

    FDA Adverse Event
    Malfunction ·COOK VASCULAR INC·Product code LJT·January 3, 2019

    MAYFIELD Composite Series Skull Clamps, Model A3059, 510(k) #K120633. The MAYFIELD Skull Clamps (A3059) are indicated for use in open and percutaneous craniotomies, as well as spinal surgery when rigid skeletal fixation is necessary.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corporation·December 26, 2012

    VITAL-PORT

    FDA Adverse Event
    Injury ·COOK VASCULAR INC·Product code LJT·May 24, 2016

    Brand Name: PALACOS Product Name: PALACOS MV pro 40; PALACOS MV pro 80 Model/Catalog Number: 5150633; 5150635 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Heraeus Medical GmbH (Dental Division)·January 21, 2026

    MAYFIELD Composite Series Skull Clamps, Model A3059, 510(k) #K120633. The MAYFIELD Skull Clamps (A3059) are indicated for use in open and percutaneous craniotomies, as well as spinal surgery when rigid skeletal fixation is necessary.

    FDA Recall
    Terminated ·Integra LifeSciences Corporation·Product code HBL·November 5, 2012

    Brand Name: PALACOS Product Name: PALACOS MV pro 40; PALACOS MV pro 80 Model/Catalog Number: 5150633; 5150635 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). Component: N/A

    FDA Recall
    Open, Classified ·Heraeus Medical GmbH (Dental Division) Philipp-Reis-Str. 8 Wehrheim Germany·Product code LOD·December 9, 2025