BEUDAMED
    18 results · 28ms · Sources: EU EUDAMED, US FDA

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    C-REACTIVE PROTEIN ANTISERUM KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092001636·artVeneer life upper anteriors, BOS, BL4

    Scanlan® SURG-I-BAND® color coding

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159001334·Scanlan® SURG-I-BAND® color coding - Narrow, Wh...

    Thuvera

    FDA UDI
    IPG Medical Corporation·00810071230011·Thuvera, Ball Tip, Single-Use Laser Fiber, 200um

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172973097·

    CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·March 12, 2026

    SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (MOXIFLOXACIN)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    STRYKER TRAUMA PLATING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GORE EXCLUDER AAA ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code MIH·March 8, 2013

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    FDA Adverse Event
    Death ·AV-TEMECULA-CT·Product code MGB·February 25, 2011

    PRECISION XTRA/OPTIUM

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE LIMITED UK·Product code NBW·February 7, 2008

    AVENIR CMPL HA HO COL SIZE7.5

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LZO·September 23, 2020

    G7 NEUTRAL E1 LINER 36MM G

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PBI·September 23, 2020

    G7 PPS LTD ACET SHELL 58G

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PBI·September 23, 2020

    Alpha-Omega Services, Inc. Product No: SPECIAL-NFV Description: CUSTOM FLEXIGUIDE NEEDLE, SERIES 15, WITH FEMALE LUER AND STYLET WITH MALE LUER 28CM, SET OF 100 Quantity: 1/PKG Lot No: K00136 L-SPECIAL- NFV. The FlexiGuide is a flexible needle designed to provide an enclosed pathway for localized radiation therapy using a Remote High Dose Rate (HDR) Afterloader or manual Low Dose Rate (LDR) method.

    FDA Recall
    Terminated ·Alpha Omega Services Inc·Product code IWJ·November 15, 2007

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    Unify, Model Numbers: CD3231-40 and CD3231-40Q; Unify Quadra, Model Numbers: CD3249-40 and CD3249-40Q; Unify Assura, Model Numbers: CD3257-40, CD3257-40Q, CD3357-40C, CD3357-40Q; Quadra Assura, Model Numbers: CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q; Quadra Assura MP, Model Numbers: CD3269-40, CD3269-40Q, CD3369-40C, CD3369-40Q Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·October 18, 2017