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

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    Filters Regulation: Us FDA ×

    1 SERIES MODEL 1 SERIES T2, 1 SERIES X2, 1 SERIES T4, 1 SERIES X4

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

    Bur PM2-70 80K Diam Ø7.0 St

    FDA UDI
    Bien-Air Surgery SA·17630055503449·

    Plum

    FDA UDI
    ICU Medical, Inc.·10887787005063·LIFESHIELD, Primary PLUM Set, Prepierced Second...

    Bur PM2-70 80K diamond Ø7.0mm sterile

    FDA UDI
    Bien-Air Surgery SA·J00711003780011·

    Osstell SmartPeg Type 06

    FDA UDI
    Osstell AB·09010522001219·ISQ Measurement Peg

    Medi-First Plus Flexible Fingertip HW

    FDA UDI
    Medique Products·00347682103781·Aflexible band of fabric material, coated on on...

    CAROTID CLAMP

    FDA UDI
    SONTEC INSTRUMENTS, INC.·B09921003780·CAROTID CLAMP ATRAUMATIC JAW

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450174623·

    HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BACT/ALERT MB CULTURE BOTTLE

    FDA 510(k)
    FDA Class 1 ·Microbiology

    microTargeting™ Frame Adapter

    FDA UDI
    FHC, INC.·00873263003787·Radionics Offsetting Frame Adapter for use with...

    OXYGENATOR, CARDIOPULMONARY BYPASS

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·July 15, 2015

    HEARTSINE SAMARITAN 300P AND PAD PAK

    FDA Adverse Event
    Malfunction ·HEARTSINE TECHNOLOGIES LTD·Product code MKJ·September 24, 2015

    FLEXCATH STEERABLE SHEATH

    FDA Adverse Event
    Malfunction ·MEDTRONIC CRYOCATH LP·Product code DRA·May 8, 2013

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 18, 2014

    Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

    Optical Access System; 5mm x 100mm and 12mm x 100mm; Model #: CTR03 and CTR73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.

    FDA Enforcement
    Class II ·Terminated·Stryker Sustainability Solutions·July 1, 2015

    Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

    FDA Enforcement
    Class II ·Terminated·Bayer Corp·June 11, 2014