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

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    NPseal

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

    ReLine

    FDA UDI
    Nuvasive, Inc.·00195377047366·RELINE-O Trial,9mm H Pedicle L-pop

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694006439·2.0mm Pilot Drill, Osteopower

    Accufit

    FDA UDI
    Ortho Organizers, Inc.·00190707183516·Accufit Molar Bands Lower Left First Molar 30 1/2

    Olympus

    FDA UDI
    Gyrus ACMI, LLC·00810008185162·ES-IP BASE SYSTEM, SPLIT RACK, FREESTANDING OPT...

    Bradshaw Medical Inc.

    FDA UDI
    Bradshaw Medical, Inc.·00810019930225·BIT, HEXALOBE 20 AO

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180174047·REPLACEMENT SEALING CAP FOR OPERATING SCOPE WIT...

    ETURN SPINAL IMPLANT MODEL ETURN XX-12; ETURN XX-16 WHERE XX=07, 09, 11, 13, OR 15 AND ETURN XX-12 K; ETURN XX-16 K WHER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HARDYDISK, CEFOXITIN, 30MCG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    DELTAPAQ - CERECYTE MICROCOIL

    FDA Adverse Event
    Malfunction ·CODMAN AND SHURTLEFF, INC·Product code HCG·October 24, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·July 1, 2013

    TAPERLC BMPC LAT 9.0X137 12/14

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JDI·August 20, 2019

    SMR SHOULDER

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code HSD·October 15, 2024

    DELTA CER FM HD 036/-4MM 12/14

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LZO·January 7, 2019

    RLOC-X E1 H/W +3MM 50/36MM 23

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JDI·January 7, 2019

    MAZOR X SYSTEM

    FDA Adverse Event
    Malfunction ·MAZOR ROBOTICS LTD·Product code OLO·January 1, 2026

    LEMAITRE VASCULAR STRAIGHT CAROTID SHUNT, MODEL 2002-01, 2002-05, 2003-01, 2003-05, 2004-01, 2004-05, 2005-01, 2005-05

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3.0 and later, PKA 3.0 and later, and TKA 1.0 - Product Usage: The MICS Handpiece is attached to the distal end of the robotic arm and is used to register the RIO (Mako robot) and to execute bone preparation during a Mako Total Knee or Mako Partial Knee procedure (PKA Software Application 3.0 or later).

    FDA Enforcement
    Class II ·Completed·Mako Surgical Corporation·November 25, 2020

    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