BEUDAMED
    18 results · 27ms · Sources: EU EUDAMED, US FDA

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    Tosoh Automated Glycohemoglobin Analyzer HLC-723G8

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    HLC-723 G8

    FDA Adverse Event
    Malfunction ·TOSOH HI-TEC, INC.·Product code PDJ·July 26, 2024

    G8

    FDA Adverse Event
    Malfunction ·TOSOH HI-TEC, INC.·Product code PDJ·August 27, 2025

    N/A

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00613994846563·CADDY 7200904 ATL VISION 2.0 LONG PLATE

    NA

    FDA UDI
    Stryker GmbH·07613154639502·Screw Marker 9,4

    METZENBAUM SCISSORS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896055896·METZENBAUM SCISSORS DELICATE CURVED TUNGSTEN CA...

    Bradshaw Medical Inc.

    FDA UDI
    Bradshaw Medical, Inc.·00810019930706·BIT, INT SCREW REMOVER 5.0MM AO

    PENADAPT 10

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

    speX LP Support Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CANN, H.F.,DGNST, 6MM, RTBL, DBL VLV

    FDA Adverse Event
    Malfunction ·SMITH & NEPHEW, INC.·Product code NBH·November 15, 2015

    ARCHITECT I2000 ANALYZER

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING, INC.·Product code JJE·October 20, 2008

    EXTENSION SET

    FDA Adverse Event
    BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·August 11, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 2, 2013

    SMR HUMERAL HEAD Ø48 MM

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code KWT·April 9, 2024

    Dexcom G4 PLATINUM (Professional) Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black. Intended to detect trends and track glucose patterns in persons with diabetes. The G4 PLATINUM CGM System and G4 PLATINUM (Professional) CGM System use the same receiver, MT20649. The kits differ due to other kit contents, such as indications for use and professional receiver shield.

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

    Olympus Sterile Optical Laser Fiber, single use and reusable

    FDA Enforcement
    Class II ·Terminated·Quanta System, S.p.A.·June 16, 2021

    Biomet Microfixation outer packaging labeled in part:"REF: SP-2411***RUBBER BAND, LATEX FREE SMALL, HEAVY, 300/PACKAGE 4MM, (3/16" INNER DIAMETER) NON LATEX ELASTICS LOT 307850***DISTRIBUTED BY: BIOMET MICROFIXATION 1520 Tradeport Drive, Jacksonville, FL 32218 USA www.biometmicrofixation.com***." Inner Vendor/Manufacturer Label labeled in part:"H4 Elastics 4mm (3/16") Heavy 4 oz. REF 11-102-04***Manufactured for DENTSPLY GAC INTERNATIONAL DENTSPLY INTERNATIONAL, INC. Phone 631-419-1700 Fax 631-419-1599 355 Knickerbocker Avenue Bohemia NY 11716 USA***MediMark Europe BP2332 F-38033 Grenoble Cedex 2. France***LOT 82936-32 QTY:100 pk use by 2012-07 Made in USA ISSUED DATE 2009-04 GN***" Elastic bands used as elastomeric ties for ligation that facilitate treatment of fracture of the mandible and maxilla. They are commonly used with braces or arch bar wire.

    FDA Recall
    Terminated ·Biomet Microfixation, Inc.·Product code ECI·August 18, 2011

    Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3.0 and later, PKA 3.0 and later, and TKA 1.0 - Product Usage: The MICS Handpiece is attached to the distal end of the robotic arm and is used to register the RIO (Mako robot) and to execute bone preparation during a Mako Total Knee or Mako Partial Knee procedure (PKA Software Application 3.0 or later).

    FDA Enforcement
    Class II ·Completed·Mako Surgical Corporation·November 25, 2020