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

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    FRAXIS DUO

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

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694036030·3.0/4.0mm Cannulated Headless Driver, Short

    Responsive Orthopedics Total Knee Arthroplasty System

    FDA UDI
    RESPONSIVE ORTHOPEDICS, LLC·00841973106487·TRIAL 90-SRK-160312 POLY CR 3X12MM

    NA

    FDA UDI
    aap Implantate AG·04042409037931·Drill guide insert CS 2.7-4.0, long

    Scorpio

    FDA UDI
    Howmedica Osteonics Corp.·07613154020447·Cruciate Retaining Tibial Insert

    B-P TOTAL HIP SYSTEM

    FDA UDI
    ENDOTEC, INC.·00814193024077·B-P MODULAR EXTENSION W/ULTRACOAT - 12 MM X 75 MM

    MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH VANCOMYCIN (0.25-64 UG/ML)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    DISTALOCK FEMORAL INTRAMEDULLARY NAIL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·November 21, 2022

    GALAXY G3 MINI 1MM X 3CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·May 21, 2020

    SOLETRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·February 12, 2014

    ACTIVA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·February 12, 2014

    INSYNC III MARQUIS

    FDA Adverse Event
    Injury ·IPG MFG SWITZERLAND·Product code NIK·June 10, 2013

    NV PRM 1LWR CLV 100"

    FDA Adverse Event
    Malfunction ·HOSPIRA, LTD.·Product code FPA·April 28, 2011

    COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 16, 2008

    I-STAT TROPONIN (CTNI) CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code MMI·August 4, 2017

    Poly Component Trial, CR, packaged in the following sizes and configurations: a) Poly Component Trial - CR 3x10, REF 90-SRK-160310 b) Poly Component Trial - CR 3x12, REF 90-SRK-160312 c) Poly Component Trial - CR 3x14, REF 90-SRK-160314 d) Poly Component Trial - CR 4x10, REF 90-SRK-160410 e) Poly Component Trial - CR 4x12, REF 90-SRK-160412 f) Poly Component Trial - CR 4x14, REF 90-SRK-160414 g) Poly Component Trial - CR 5x10,REF 90-SRK-160510 h) Poly Component Trial - CR 5x12, REF 90-SRK-160512 i) Poly Component Trial - CR 5x14, REF 90-SRK-160514 j) Poly Component Trial - CR 6x10, REF 90-SRK-160610 k) Poly Component Trial - CR 6x12, REF 90-SRK-160612 l) Poly Component Trial - CR 6x14, REF 90-SRK-160614 The Responsive Orthopedics (RO) Total Knee Arthroplasty (TKA) System is intended to restore alignment, stability, range of motion, and alleviate pain by replacing the articulating surfaces of the knee joint

    FDA Enforcement
    Class II ·Terminated·Medtronic Sofamor Danek USA Inc·March 29, 2017

    Poly Component Trial, CR, packaged in the following sizes and configurations: a) Poly Component Trial - CR 3x10, REF 90-SRK-160310 b) Poly Component Trial - CR 3x12, REF 90-SRK-160312 c) Poly Component Trial - CR 3x14, REF 90-SRK-160314 d) Poly Component Trial - CR 4x10, REF 90-SRK-160410 e) Poly Component Trial - CR 4x12, REF 90-SRK-160412 f) Poly Component Trial - CR 4x14, REF 90-SRK-160414 g) Poly Component Trial - CR 5x10,REF 90-SRK-160510 h) Poly Component Trial - CR 5x12, REF 90-SRK-160512 i) Poly Component Trial - CR 5x14, REF 90-SRK-160514 j) Poly Component Trial - CR 6x10, REF 90-SRK-160610 k) Poly Component Trial - CR 6x12, REF 90-SRK-160612 l) Poly Component Trial - CR 6x14, REF 90-SRK-160614 The Responsive Orthopedics (RO) Total Knee Arthroplasty (TKA) System is intended to restore alignment, stability, range of motion, and alleviate pain by replacing the articulating surfaces of the knee joint

    FDA Recall
    Terminated ·Medtronic Sofamor Danek USA Inc·Product code JWH·February 20, 2017

    Artis zeego, Model Number 10280959

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 31, 2019

    Mucosal Atomization Device (MAD), Intranasal Mucosal Atomization Device with 3mL Syringe and Vial Adapter; Product Code MAD100, MAD100OS MAD110, MAD110OS, MAD130, MAD130OS, MAD140, MAD140OS, MAD300, MAD300B. Manufactured By: Wolfe-Tory Medical, Inc., Teleflex Medical. For atomization of topical solutions across the naso and oropharyngeal mucosal membranes

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·December 28, 2016