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

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    CORE1 Implant System

    FDA 510(k)
    FDA Class 2 ·Dental

    NA

    FDA UDI
    Smith & Nephew, Inc.·03596010510969·GTS TAPERED SCREW 7MM X 30MM

    AMPLITUDE

    FDA UDI
    AMPLITUDE SAS·03701089500845·Resurfacing Patellar Implant NM Cemented Ø 39 mm

    Drug-Eluting Peripheral Transluminal Angioplasty Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·Chocolate Touch Paclitaxel Drug-Coated PTA Balloon Catheter (Chocolate Touch)

    XtraFix® External Fixation System

    FDA UDI
    Zimmer, Inc.·00889024081161·

    QUICKTEK BLOOD GLUCOSE SYSTEM, QUICKTEK BLOOD GLUCOSE METER, QUICKTEK BLOOD GLUCOSE STRIPS, QUICKTEK CONTROL SOLUTION

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BIOMET SPORTS MEDICINE STERNAL CLOSURE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Drug-Eluting Peripheral Transluminal Angioplasty Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·Chocolate Touch Paclitaxel Drug-Coated PTA Balloon Catheter (Chocolate Touch)

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES SELZACH·Product code HWC·November 9, 2015

    SM PLUS SBT/ OVAL BALLOON DISSECTOR

    FDA Adverse Event
    Malfunction ·NORTH HAVEN- USS·Product code GDI·October 21, 2008

    SURGIPRO 8/0 18 BLUE MV-175-8 D/A

    FDA Adverse Event
    Injury ·UNITED STATES SURGICAL·Product code GAW·August 3, 2011

    FINELINE II

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code DTB·July 8, 2013

    TRIUMPH-1 PORT

    FDA Adverse Event
    Injury ·HORIZON MEDICAL PRODUCTS, INC.·Product code LJT·May 3, 1999

    RESOLUTE ONYX RX

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code NIQ·September 27, 2021

    Hydrodissection Cannula (Chang), 27g, labeled as: anodynesurgical, REF 7018 ASICO, REF AS-7638 anodynesurgical, REF 7018NS katena, REF K20-3168 anodynesurgical, REF 104910 MSI, REF CA7800 ACCUTONE, REF AX14784-BULK Walcott Rx Products, REF RX2300NS Walcott Rx Products, REF RX2300

    FDA Enforcement
    Class II ·Terminated·Anodyne Surgical·June 23, 2021

    Dexcom G4 PLATINUM (Pediatric) Receiver with Share Receiver Part Number: MT22608 Receiver (mg/dL), Black (pediatrics); MT22608-PNK, Receiver (mg/dL), Pink (pediatrics); MT22608-BLU, Receiver (mg/dL), Blue (pediatrics). Intended to detect trends and track glucose patterns in persons with diabetes.

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

    DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·April 19, 2023

    ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·July 9, 2014

    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

    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