BEUDAMED
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    SNUCONE Bone Level Implant System

    FDA 510(k)
    FDA Class 2 ·Dental

    PMT CORPORATION - STEREOTACTIC

    FDA UDI
    PMT CORPORATION·00650551039532·REDUCING BUSHING AND THUMB SCREW, FOR 3.2MM DRILL

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319722084·Lewis (Joseph) Rasp 7-1/2" (18.8cm), backward c...

    OFFSET ACETABULAR

    FDA UDI
    Biomet Orthopedics, LLC·00880304451070·

    REGENEREX HIP SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304450202·

    5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/65MM

    FDA Adverse Event
    Injury ·SYNTHES MEZZOVICO·Product code JDP·August 28, 2015

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·January 26, 2015

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·March 2, 2015

    KIMTECH PURPLE NITRILE EXAM GLOVES, STERILE SINGLES (XS)

    FDA UDI
    KIMBERLY-CLARK GLOBAL SALES, LLC·10036000521037·Examination Gloves

    IMPLANT, FIXATION DEVICE CONDYLAR PLATE

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code JDP·February 23, 2017

    BETA-TCP GRANULES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    4.5MM VA-LCP CURVED CONDYLAR PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    IMPLANT, FIXATION DEVICE, CONDYLAR PLATE

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code JDP·June 1, 2015

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·October 29, 2014

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·August 12, 2011

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·July 8, 2013

    4.5MM VA-LCP CURVED CONDYLAR PLATE/6 HOLE/159MM/RIGHT

    FDA Adverse Event
    Injury ·SYNTHES MEZZOVICO·Product code HRS·July 24, 2015

    ARROW HEMODIALYSIS KIT: 2-L 14 FR X 20 CM ANTI

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC.·Product code FOZ·February 23, 2018

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system 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.·August 5, 2015