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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    MIRA Adapter

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Zavation

    FDA UDI
    Zavation LLC·00842166131996·Ti3Z CIF 12mmx14mmx11mm -9 deg

    METZENBAUM SCISSORS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896055919·METZENBAUM SCISSORS WITH GOLD SCREW CURVED BLAD...

    PLIF Cage

    FDA UDI
    Eisertech, LLC·B5231003576200911·Lordotic TPLIF Cage, Titanium 20AP X 09ML X 11H...

    Phantom Plus Cage System

    FDA UDI
    SINTX Technologies, Inc.·M555315200911·Straight Osteotome

    BD PRECISIONGLIDE¿ NEEDLE

    FDA Adverse Event
    Injury ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·May 30, 2019

    MID LABS AUTONOMOUS VIT ENHANCER (AVE)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    MICROGRASP BIPOLAR COAGULATOR, MODELS 90048-90057

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

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·October 5, 2015

    QUICK SET PARADIGM

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·November 2, 2009

    AED PLUS

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS·Product code MKJ·September 16, 2014

    CADENCE ZOLL PRECONNECT

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code MLN·June 30, 2011

    COMPLETE SE

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code NIO·July 2, 2013

    Shutter HX SP5, a component of the Leica Point Scanning Confocal Microscope Models TCS SP5 and TCS SP5 X. Laboratory instrument.

    FDA Recall
    Terminated ·Leica Microsystems, Inc.·Product code REM·November 12, 2009

    MPR Slotted Mallet, labeling etched onto devices as follows: Medical Products Resource 800.524.5194 www.m-p-r.com MPR-1120-1000 (01)00840001405868

    FDA Enforcement
    Class II ·Ongoing·Implant Resource Inc·October 27, 2021

    Product is labeled in part: "CP-SM397A-02...Mono-Dox Violet Monofilament Polydioxanone Synthetic Absorbable Sterile Suture. Do Not Resterilize.... 4/0 (1.5 metric) 30" (75cm) Rx Only...LOT L0535440 EXP 2009-11...4/0 M397A...Mono-Dox CUTTING NFS-2 NEEDLE...Manufactured by: CP Medical, Portland, OR USA". Intended for use in general soft tissue approximation and/or ligation including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery.

    FDA Recall
    Terminated ·C P Medical·Product code NEW·September 17, 2008

    Dexcom G4 PLATINUM Receiver with Share Receiver Part Number: MT22495 Receiver (mg/dL), Black; MT22495-PNK, Receiver (mg/dL), Pink; MT22495-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.

    FDA Enforcement
    Class I ·Terminated·Dexcom Inc·April 20, 2016

    SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C

    FDA Enforcement
    Class II ·Ongoing·FUJIFILM Healthcare Americas Corporation·September 21, 2022

    Toshiba Infinix-i X-Ray System. A radiographic and fluoroscopic x-ray system for use in diagnostic and angiographic procedures.

    FDA Enforcement
    Class II ·Terminated·Toshiba American Medical Systems Inc·April 3, 2013

    Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.

    FDA Enforcement
    Class II ·Ongoing·Draegar Medical Systems, Inc.·May 4, 2022