BEUDAMED
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    CAPTIVA SPINE CAPLOX II SPINAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DD tempMED

    FDA UDI
    Dental Direkt GmbH·EDDIK111151·DD tempMED are pre-colored dental milling blank...

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613094935·Splinter Forceps, Curved, Without Pin, Serrated...

    n/a

    FDA UDI
    Ortho Development Corporation·00822409076024·Femoral Broach/Trial 1115

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613020088·USA Model Dressing Forceps, Overall Length 4-1/...

    COMPREHENSIVE®

    FDA UDI
    Biomet Orthopedics, LLC·00880304456594·

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197411738·Metzenbaum - Baby Dissecting Scissor Fig. 1...

    KURZ UPPER EYELID IMPLANT- PLATINUM/IRIDIUM,MODELS REGULAR 4007 003-007, SPECIAL 4007 002, 4007 008-010

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    ELI 150 ELECTROCARDIOGRAPH MODEL ELI 150

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Widex

    FDA UDI
    Widex A/S·05706069885811·WIDEX MOMENT MRB0 (Chestnut brown ) 110, RIC 10

    PEDICLE SCREW 7X45

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code KWP·April 10, 2018

    Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code CBK·April 18, 2022

    Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)

    FDA Enforcement
    Class I ·Ongoing·GE Healthcare, LLC·June 15, 2022

    PEDICLE SCREW 7X50

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code KWP·February 23, 2018

    PEDICLE SCREW 5X45

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code KWP·March 23, 2018

    M.U.S.T. RODS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code KWP·April 20, 2026

    PEDICLE SCREW PEDICLE SCREW 5X40

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code KWP·January 17, 2024

    M.U.S.T. POLYAXIAL PEDICLE SCREW

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MNI·October 28, 2024

    LIGAMAX-5MM ENDO CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·May 14, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 23, 2014