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

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    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0140110·T-Handle, T30 Split Tip, Extended Assembly

    CANVAS N-VAS-D 2.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    Versacryl

    FDA UDI
    Keystone Industries·H66810140111·Acrylic SC Hardener Liquid 60 ml

    ANCA Test System

    FDA UDI
    IMMUNO CONCEPTS INC·M74910140111·ANCA FA Test System - Ethanol Fixed Substrate -...

    Aztec

    FDA UDI
    Aztecmed/Ent LLC·B87110140110·Boise Nasal Fracture Elevator

    EVOS Lumbar Interbody System

    FDA UDI
    Cutting Edge Spine, LLC·00841193101880·EVOS Straight HA PEEK 11mm x 9mm x 22mm Flat, 5...

    ANCA Test System

    FDA UDI
    IMMUNO CONCEPTS INC·M7491014011T1·ANCA FA Test System - Ethanol Fixed Substrate -...

    Medline Industries, Inc.

    FDA UDI
    MEDLINE INDUSTRIES, INC.·10080196985012·CIRCUIT-PEDIATRIC ANESTHESIA

    TE-2000 POWER TILT/POWER ELEVATING SEAT COMBINATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    IMPRA CARBOFLO VASCULAR GRAFT, IMPRA CARBOFLO VASCULAR GRAFTS FOR A-V ACCESS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NEXGEN LPS-FLEX GSF FEMORAL COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER·Product code JWH·November 7, 2014

    DERMATOME BLADES

    FDA Adverse Event
    Injury ·ZIMMER SURGICAL, INC.·Product code GFD·October 26, 2023

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 21, 2013

    IDENTITY SR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWP·March 10, 2011

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·March 13, 2008

    DERMATOME BLADES

    FDA Adverse Event
    Injury ·ZIMMER SURGICAL, INC.·Product code GFD·September 26, 2023

    TERUMO PERFUSION SYSTEM 8000

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DWB·December 22, 2014

    WALLACH LL 100 cryosurgical units: LL100 Cryosurgical - Part Number 900001; LL110 with Pinned Yoke - Part Number 900019-70; LL100 Multi Tip W/TC - Part Number: 900629; LL100 - CO2 - Part Number 900162

    FDA Enforcement
    Class II ·Terminated·CooperSurgical, Inc.·April 22, 2015

    Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05

    FDA Enforcement
    Class II ·Ongoing·CooperSurgical, Inc.·November 24, 2021

    AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) HEART PACK - 205947, MODEL/ITEM NUMBER ANCV78BC; 2) VASCULAR PACK - 232024, MODEL/ITEM NUMBER ANVA82AB; 3) OFF PUMP CABG PACK - 170316, MODEL/ITEM NUMBER BHOP48O; 4) OFF PUMP CABG PACK - 170316, MODEL/ITEM NUMBER BHOP48P; 5) PEDIATRIC OPEN HEART PACK - 170212, MODEL/ITEM NUMBER BHPH18F; 6) PEDIATRIC OPEN HEART PACK - 170212, MODEL/ITEM NUMBER BHPH18G; 7) CABG ACCESSORY PACK, MODEL/ITEM NUMBER HGCB98F; 8) CV SET UP PACK, MODEL/ITEM NUMBER HGCV05K; 9) OPEN HEART PACK B - COMPONENTS, MODEL/ITEM NUMBER HGOH99H; 10) STRADLE TABLE PACK - 301659, MODEL/ITEM NUMBER MHCV10AM; 11) MINOR VASCULAR PACK, MODEL/ITEM NUMBER MTVS73D; 12) AV GRAFT RCH 0246952, MODEL/ITEM NUMBER RCAV40C; 13) OPEN HEART PART 1 RCH 0247159, MODEL/ITEM NUMBER RCOH61G; 14) CARDIO 612968, MODEL/ITEM NUMBER TNCA08T; 15) CV B PACK, MODEL/ITEM NUMBER TNCB10AM; 16) A-V FISTULA - 206042, MODEL/ITEM NUMBER UDAV16AD; 17) CAROTID PACK - 206045, MODEL/ITEM NUMBER UDCP24AF; 18) FEM POP PACK - 206052, MODEL/ITEM NUMBER UDFP36AH; 19) CARDIOVASCULAR SUPPLY (PS 907285), MODEL/ITEM NUMBER UICD62AN; 20) SFCH PEDS CARDIAC SUPPLY PACK (PS131653), MODEL/ITEM NUMBER UICS88S; 21) SFCH ECMO PACK (PS 107116), MODEL/ITEM NUMBER UIPD03Q; 22) THORACIC SETUP (PS 035700), MODEL/ITEM NUMBER UITC53AL; 23) VASCULAR PACK, MODEL/ITEM NUMBER UIVA75J; 24) CABG ACCESSORY PACK 175619, MODEL/ITEM NUMBER UMCA14E; 25) OPEN HEART ACCESS PACK 175628, MODEL/ITEM NUMBER UMOH42E; 26) OPEN HEART ACCESS PACK 175628, MODEL/ITEM NUMBER UMOH42F; 27) OPEN HEART ACCESS PACK 175628, MODEL/ITEM NUMBER UMOH42G.

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems Inc·September 3, 2025