BEUDAMED
    10 results · 28ms · Sources: EU EUDAMED, US FDA

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    Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Bernafon

    FDA UDI
    Bernafon AG·05711584114919·CZ7 MNR, 2.4G NFM MAC CORAL 7 GPL

    IN:C2 SPINAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    REPROCESSED LINVATEC ARTHROSCOPIC BURS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACTIVA

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·May 18, 2018

    SYNCHROMED EL

    FDA Adverse Event
    Injury ·RICE CREEK MFG.·Product code LKK·August 11, 2011

    PRECISION

    FDA Adverse Event
    Injury ·BOSTON SCIENTFIC NEUROMODULATION CORPORATION·Product code LGW·October 24, 2008

    GYNECARE PROLIFT TOTAL PELVIC FLOOR REPAIR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTP·July 9, 2013

    BEAD TIP GD WIRE 3.0MM X 60CM; 29402 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·June 27, 2018

    18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer  10041227 & 10789400 S1000  10441701 S2000  10041461 S2000 (Refurb) - 10440017 S3000  10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·May 3, 2017