BEUDAMED
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    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    Assist Bed Rail - 6632

    FDA Enforcement
    Class II ·Terminated·Invacare Corporation·June 7, 2017

    Germ Terminator, Toothbrush Steam Sterilization for Oral Health. Model GT100. The Germ Terminator uses steam heat to sanitize two manual toothbrushes or two toothbrush heads. Water is poured into a reservoir in the device's housing. The steam cycle is followed by a drying cycle.

    FDA Enforcement
    Class II ·Terminated·Ceg Enterprises Llc·June 29, 2016

    EEG NeuroAmp, Model Number: CS 10090; CS 10137. Biofeedback and Relaxation

    FDA Enforcement
    Class II ·Terminated·EEG Info·December 26, 2012

    CME America T-Syringe Pump - Ameritus 1st Enteral Pump - 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

    00720504022 ACETAB.CUPW/SH,0DEG,22MMX40MM 00720504222 ACETAB.CUPW/SH,0DEG,22MMX42MM 00720504622 ACETAB.CUPW/SH,0DEG,22MMX46MM 00720504828 ACETAB.CUPW/SH,0DEG,28MMX48MM 00720505228 ACETAB.CUPW/SH,0DEG,28MMX52MM 00720505628 ACETAB.CUPW/SH,0DEG,28MMX56MM 00720505828 ACETAB.CUPW/SH,0DEG,28MMX58MM 00720506028 ACETAB.CUPW/SH,0DEG,28MMX60MM 00720506228 ACETAB.CUPW/SH,0DEG,28MMX62MM 00720506428 ACETAB.CUPW/SH,0DEG,28MMX64MM 00721004222 ACETAB.CUPW/SH,10DEG,22MMX42MM 00721004422 ACETAB.CUPW/SH,10DEG,22MMX44MM 00721005028 ACETAB.CUPW/SH,10DEG,28MMX50MM 00721005228 ACETAB.CUPW/SH,10DEG,28MMX52MM 00721005628 ACETAB.CUPW/SH,10DEG,28MMX56MM 00721006428 ACETAB.CUPW/SH,10DEG,28MMX64MM 00721006628 ACETAB.CUPW/SH,10DEG,28MMX66MM 00721006828 ACETAB.CUPW/SH,10DEG,28MMX68MM 00721007028 ACETAB.CUPW/SH,10DEG,28MMX70MM 00725504222 ACETAB.CUP, 0 DEG, 22MM X 42MM 00725504622 ACETAB.CUP, 0 DEG, 22MM X 46MM 00725504626 ACETAB.CUP, 0 DEG, 26MM X 46MM 00725504828 ACETAB.CUP, 0 DEG, 28MM X 48MM 00725505232 ACETAB.CUP, 0 DEG, 32MM X 52MM 00725505432 ACET CUP, 0 DEG, 32MM X 54MM 00725505632 ACET CUP, 0 DEG, 32MM X 56MM 00725505828 ACETAB.CUP, 0 DEG, 28MM X 58MM 00725505832 ACET CUP, 0 DEG, 32MM X 58MM 00725506028 ACETAB.CUP, 0 DEG, 28MM X 60MM 00725506032 ACET CUP, 0 DEG, 32MM X 60MM 00725506228 ACETAB.CUP, 0 DEG, 28MM X 62MM 00725506232 ACET CUP, 0 DEG, 32MM X 62MM 00725506428 ACETAB.CUP, 0 DEG, 28MM X 64MM 00725506432 ACET CUP, 0 DEG, 32MM X 64MM 00725506628 ACETAB.CUP, 0 DEG, 28MM X 66MM 00725506632 ACET CUP, 0 DEG, 32MM X 66MM 00725506828 ACETAB.CUP, 0 DEG, 28MM X 68MM 00725506832 ACET CUP, 0 DEG, 32MM X 68MM 00725507028 ACETAB.CUP, 0 DEG, 28MM X 70MM 00725507032 ACET CUP, 0 DEG, 32MM X 70MM 00726004222 ACETAB.CUP,10 DEG, 22MM X 42MM 00726004828 ACETAB.CUP,10 DEG, 28MM X 48MM 00726005028 ACETAB.CUP,10 DEG, 28MM X 50MM 00726005228 ACETAB.CUP,10 DEG, 28MM X 52MM 00726005232 ACETAB.CUP,10 DEG, 32MM X 52MM 00726005432 ACET CUP, 10 DEG, 32MM X 54MM 00726005632 ACET CUP, 10 DEG, 32MM X 56MM 00726005832 ACET CUP, 10 DEG, 32MM X 58MM 00726006032 ACET CUP, 10 DEG, 32MM X 60MM 00726006428 ACETAB.CUP,10 DEG, 28MM X 64MM 00726006432 ACET CUP, 10 DEG, 32MM X 64MM 00726006628 ACETAB.CUP,10 DEG, 28MM X 66MM 00726006632 ACET CUP, 10 DEG, 32MM X 66MM 00726006828 ACETAB.CUP,10 DEG, 28MM X 68MM 00726006832 ACET CUP, 10 DEG, 32MM X 68MM 00726007028 ACETAB.CUP,10 DEG, 28MM X 70MM 00726007032 ACET CUP, 10 DEG, 32MM X 70MM

    FDA Enforcement
    Class II ·Terminated·Zimmer Trabecular Metal Technology, Inc.·June 22, 2016

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. 0 DEG ACUMATCH CONSTRAINED LINER SZ E 28MM ID, REF 144-28-05; b. 0 DEG ACUMATCH CONSTRAINED LINER SZ F 28MM ID, REF 144-28-06; c. 0 DEG ACUMATCH CONSTRAINED LINER SZ G 28MM ID, REF 144-28-07; d. 0 DEG ACUMATCH CONSTRAINED LINER SZ H 28MM ID, REF 144-28-08; e. 0 DEG ACUMATCH CONSTRAINED LINER SZ J 28MM ID, REF 144-28-09; f. 0 DEG ACUMATCH CONSTRAINED LINER SZ K 28MM ID, REF 144-28-10; g. 0 DEG MCS CONSTRAINED LINER 50-52 MM, 28 MM ID, REF 146-28-04; h. 0 DEG MCS CONSTRAINED LINER 54-58 MM, 28 MM ID, REF 146-28-05; i. 0 DEG MCS CONSTRAINED LINER 60-64 MM, 32MM ID, REF 146-32-06; j. O DEG ACUMATCH CONSTRAINED LINER SZ E 32MM ID, REF 144-32-05; k. O DEG ACUMATCH CONSTRAINED LINER SZ F 32MM ID, REF 144-32-06; l. O DEG ACUMATCH CONSTRAINED LINER SZ G 32MM ID, REF 144-32-07; m. O DEG ACUMATCH CONSTRAINED LINER SZ H 32MM ID, REF 144-32-08; n. O DEG ACUMATCH CONSTRAINED LINER SZ J 32MM ID, REF 144-32-09; o. O DEG ACUMATCH CONSTRAINED LINER SZ K 32MM ID, REF 144-32-10;

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

    Exactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG PE 38MM HUM LINER +0/ 320-38-03,145-DEG PE 38MM HUM LINER +2.5/ 320-42-00,145-DEG PE 42MM HUM LINER +0/ 320-42-03,145-DEG PE 42MM HUM LINER +2.5/

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 24, 2025

    14 x 11 x 6mm 7 deg 14 x 11 x 7mm 7 deg 14 x 11 x 8mm 7 deg 14 x 11 x 9mm 7 deg 14 x 11 x 10mm 7 deg 14 x 11 x 11mm 7 deg 14 x 11 x 12mm 7 deg Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.

    FDA Enforcement
    Class II ·Terminated·Spinal Solutions, LLC·June 5, 2013

    Exactech Equinoxe, Reverse Shoulder Humeral Liners, 322-38-00 (145-DEG PE 38MM HUM LINER +0), REF: 322-38-03 (145-DEG PE 38MM HUM LINER +2.5), REF:322-42-00 (145-DEG PE 42MM HUM LINER +0), REF: 322-42-03 (145-DEG PE 42MM HUM LINER +2.5)

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 24, 2025

    Seer Home System is an ambulatory electroencephalograph (EEG) system intended for at-home use for extended EEG and video EEG (vEEG) recordings and analysis. The Seer Home System includes the Sight Monitoring Hub, the Sense wearable, Monitoring Portal and associated accessory components (Disposable EEG Wires, WaterTabs, WaterTabs Application Kit, and Take-home Kit).

    FDA Enforcement
    Class II ·Ongoing·SEER MEDICAL PTY LTD·September 25, 2024

    Olympus ENDOEYE HD II Video Telescopes Models: WA50040A Endoeye HD II, 10 mm, 0 deg., autoclavable; WA50042A Endoeye HD II, 10 mm, 30 deg., autoclavable; repair cable 10mm 0/30 deg., part number W7100603

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·May 10, 2017

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH +5MM LAT LINER 15 DEG 36MM ID, SIZE H, REF 138-36-08 b. ACUMATCH +5MM LAT LINER 15 DEG 36MM ID, SIZE J, REF 138-36-09 c. ACUMATCH LINER 15 DEG 36MM ID, SIZE H, REF 132-36-08 d. ACUMATCH LINER 15 DEG 36MM ID, SIZE J, REF 132-36-09 e. ACUMATCH LINER 15 DEG 36MM ID, SIZE K, REF 132-36-10

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

    WAVi Research EEG Desktop System is comprised of the WAVi Research EEG Desktop Software with Instruction Manual and Brochure, and Heart Rate Variability (HRV) Ear Clips. The system kit also incorporates use of the firm's cleared EEG analysis technology (the WAVi SCAN EEG System and Accessories, and the WAVi Headset and eSoc Single Use Electrode Contacts).

    FDA Enforcement
    Class II ·Ongoing·WAVi Co.·June 12, 2024

    ACE Trochanteric Nail System ACE TROCH NAIL 125 DEG. X 11MM ACE TROCH NAIL 130 DEG. X 11MM ACE TROCH NAIL 135 DEG. X 11MM ACE TROCH NAIL 125 DEG. X 13MM ACE TROCH NAIL 130 DEG. X 13MM ACE TROCH NAIL 135 DEG. X 13MM The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail System is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal nonunions and malunions and revision procedures.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·April 4, 2018

    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-28-XX, MCS +5GXL Liner 5/15 DEG and MCS GXL Liner 5/15 DEG. Orthopedic hip implant component.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·July 28, 2021

    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-32-XX, MCS +5GXL Liner 5/15 DEG and MCS GXL Liner 5/15 DEG. Orthopedic hip implant component.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·July 28, 2021

    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-36-XX, MCS +5GXL Liner 5/15 DEG and MCS GXL Liner 5/15 DEG. Orthopedic hip implant component.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·July 28, 2021

    Nicolet¿ Ambulatory EEG

    FDA Enforcement
    Class II ·Terminated·Natus Neurology Inc·August 8, 2018

    XLTEK EMU40EX EEG Headbox

    FDA Enforcement
    Class II ·Terminated·Natus Neurology DBA Excel Tech., Ltd. (XLTEK)·August 8, 2018

    ZIMTRON 6 DEG 22 HEADS

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·February 26, 2014