BEUDAMED
    22 results · 25ms · Sources: EU EUDAMED, US FDA

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    EPISTAXIS NASAL PACK

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    N/A

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00613994301796·COMPRESSOR 7971000 SM

    CONNECTOR 22M - 30F

    FDA UDI
    Intersurgical Incorporated·05030267057597·CONNECTOR 22M - 30F

    PCRopsis

    FDA UDI
    ENTOPSIS, LLC·B55059710000·PCRopsis™ Lysis Beads (1 kilogram, bulk) facili...

    BAHADIR USA

    FDA UDI
    BAHADIR USA LLC·00859982006179·METAL ID LABEL, CUSTOM ENGRAVE, SILVER

    Trab Probe

    FDA UDI
    KATENA PRODUCTS, INC.·00841668108451·HARMS TRABECULOTOMY PROBE RIGHT

    Isolibrium

    FDA UDI
    STRYKER CORPORATION·07613327278392·

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523130597·Tapered Cementless Stem Case

    P60 Series Digital Color Doppler Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    MYRIAN

    FDA 510(k)
    FDA Class 2 ·Radiology

    LEVIN TUBE

    FDA Adverse Event
    Death ·DAVOL INC. SUBSIDIARY OF CR BARD INC.·Product code FPD·March 24, 1997

    PULSE GEN MODEL 103

    FDA Adverse Event
    Injury ·CYBERONICS - HOUSTON·Product code MUZ·November 10, 2017

    PCRopsis Lysis Beads, IVDD: a) 25 tubes , REF 597000; b) 25 tubes, REF 597825; c) 50 tubes, REF 597850; d) 25 grams, REF 5970025; e) 1000 kilogram, REF 5971000; coated beads that facilitate lysis of microorganisms; nucleic acid extraction from a variety of biological samples

    FDA Enforcement
    Class II ·Ongoing·Entopsis , Inc.·April 5, 2023

    ENDOPATH ELECTROSURGERY PROBE PLUS II

    FDA Adverse Event
    Malfunction ·EES-JUAREZ·Product code KNS·February 19, 1997

    ENDOPATH THORACIC ENDOLINEAR CUTTER W/SAFETY LOCKOUT

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code GAG·January 30, 1997

    SCREW

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·February 21, 2013

    1X8 SUB COMPACT TEST STIMULATION LEAD

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code GZB·January 6, 2011

    UNK M/L TAPER STEM

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code LZO·July 8, 2014

    ENDOPATH TRISTAR EXTRAPERITONEAL DISSECTOR

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code GCJ·May 8, 1997

    PCRopsis Lysis Beads, IVDD: a) 25 tubes , REF 597000; b) 25 tubes, REF 597825; c) 50 tubes, REF 597850; d) 25 grams, REF 5970025; e) 1000 kilogram, REF 5971000; coated beads that facilitate lysis of microorganisms; nucleic acid extraction from a variety of biological samples

    FDA Recall
    Open, Classified ·Entopsis Inc.·Product code JJH·February 21, 2023