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

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    SYNTHETIC SEEDING SPACER MODEL SS9 X 50-50, SS9 X 55-50, SS9 X 55-150, SS9 X 1CM-30

    FDA 510(k)
    FDA Class 2 ·Radiology

    Bur PM2-70 50K Diam Ø3.5x80

    FDA UDI
    Bien-Air Surgery SA·17630055514766·

    NELSON-METZENBAUM SCISSORS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896049826·METZENBAUM SCISSORS TUNGSTEN CARBIDE CURVED BLADE

    MAXCUT DIAMOND BURS (6/pk) MED 847-014

    FDA UDI
    SCOTT'S DENTAL SUPPLY L.L.C.·D778100847141·MAXCUT DIAMOND BURS (6/pk) Shape: Flat End Tape...

    MAXCUT DIAMOND BURS (6/pk) MED 847-018

    FDA UDI
    SCOTT'S DENTAL SUPPLY L.L.C.·D778100847181·MAXCUT DIAMOND BURS (6/pk) Shape: Flat End Tape...

    MAXCUT DIAMOND BURS (6/pk) MED 847-016

    FDA UDI
    SCOTT'S DENTAL SUPPLY L.L.C.·D778100847161·MAXCUT DIAMOND BURS (6/pk) Shape: Flat End Tape...

    MAXCUT DIAMOND BURS (6/pk) MED 847-012

    FDA UDI
    SCOTT'S DENTAL SUPPLY L.L.C.·D778100847121·MAXCUT DIAMOND BURS (6/pk) Shape: Flat End Tape...

    K'FIX

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ORALUBE

    FDA 510(k)
    FDA Class 1 ·Dental

    Widex

    FDA UDI
    Widex A/S·05706069729771·Widex EVOKE E-FP (Tan silk S-220 ) Telecoil, Vo...

    Widex

    FDA UDI
    Widex A/S·05706069727371·Widex EVOKE E-FM (Tan silk S-220 ) RC coil

    Widex

    FDA UDI
    Widex A/S·05706069727777·Widex EVOKE E-FA (Tan silk S-220 ) Telecoil, Vo...

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 24, 2015

    COULTER® LH 750 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·May 8, 2013

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·TANDEM DIABETES CARE INC.·Product code LZG·September 12, 2014

    IVEA Product Part Number 16100 Model 500A

    FDA Enforcement
    Class II ·Terminated·Firefly Medical, Inc.·October 11, 2017

    CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).

    FDA Enforcement
    Class II ·Terminated·CME America, LLC·December 9, 2020

    INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    The PrisMax System Version II Hemodialysis Delivery System: Automatic Repositioning System Pump Assembly, specifically tubing, Model Numbers: a) 955626 b) 955558 c) 955701 PrisMax V2 Preventive Maintenance Kit, Product Code SC616 ARPS PUMP, Product Code SC6035 ARPS Pump Assembly, Product Code SC6053

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·March 10, 2021

    Altrua 2 pacemaker, Models: a) S701 b) S702 c) S722

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·July 14, 2021