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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    MEDISPO (POWDERED) AND MEDISPO-PF (POWDER-FREE) SURGEONS GLOVE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    AESCULAP

    FDA UDI
    B BRAUN SURGICAL SA·04046963835682·HISTOACRYL TRANSLUCENT 10 AMP OF 0.5 ML

    APOLLO

    FDA UDI
    Conmed Corporation·20653405051593·APOLLO PAPILLOTOME

    MedGyn Pessary Cube w/drain # 5

    FDA UDI
    MEDGYN PRODUCTS, INC.·M803050071·Cube Pessary is used treat uterine prolapse.

    Copper Ni-Ti - Archwire

    FDA UDI
    ORMCO CORPORATION·00889989025637·COPPER NITI 35 BAF18 DIA.LO LG PK10

    A&E Medical / Disposable Suction Coagulator

    FDA UDI
    A & E MEDICAL CORPORATION·20841291105043·Suction Coagulator, 50 per box

    N/A

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036025625·

    Unimed

    FDA UDI
    Unimed Medical Supplies, Inc.·06936735469246·One-piece ECG Monitor Cable SCHILLER

    VIRIDIS DERMA LASER

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

    SYNTHETIC POWDER FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    NA

    FDA UDI
    STRYKER CORPORATION·07613327051568·Stryker/ACMI/Zimmer Adapter

    EASYTRAK 3

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code OJX·April 10, 2013

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·March 31, 2011

    MESH

    FDA Adverse Event
    Injury ·Product code FTL·May 21, 2008

    HANDPIECE MICS

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·December 5, 2018

    Disetronic H-TRONplus Insulin Pump; catalog # 8050023 [clear case], 8050064 [blue case], 8050021 [solid-color case] and 8050071 [yellow case].

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code LZG·July 21, 2003

    Aurora 2 Series, Aurora 7 lighthead; Models: AUR7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS, REF 130-32-51 b. NOVATION GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS, REF 130-36-52 c. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 3 CUPS, REF 130-40-53 d. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 4 CUPS, REF 130-40-54 e. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 5 CUPS, REF 130-40-55 f. NOVATION GXL LINER LIPPED 32MM ID, GROUP 1 CUPS, REF 132-32-51 g. NOVATION GXL LINER LIPPED 36MM ID GROUP 2, REF 132-36-52 h. NOVATION GXL LINER LIPPED 40MM ID, GROUP 3 CUPS, REF 132-40-53 i. NOVATION GXL LINER LIPPED 40MM ID, GROUP 4 CUPS, REF 132-40-54 j. NOVATION GXL LINER LIPPED 40MM ID, GROUP 5 CUPS, REF 132-40-55 k. NOVATION GXL LINER +5 LAT 40MM GROUP 3 CUPS, REF 136-40-53 l. NOVATION GXL LINER +5 LAT 40MM ID GROUP 4 CUPS, REF 136-40-54 m. NOVATION GXL LINER +5 LAT 40MM ID GROUP 5 CUPS, REF 136-40-55 n. NOVATION GXL LINER 10 DEG FACE 40MM ID, GRP 3 CUP, REF 138-40-53 o. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 4 CUP, REF 138-40-54 p. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 5 CUP, REF 138-40-55

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022

    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018