BEUDAMED
    20 results · 18ms · 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 Status: Open, Classified ×

    EQ-400-RH-QZ and EQ-400-LH-BK products Product Usage: The device is a very broadband light source emitting incoherent non-laser light from the Deep UV through the visible wavelengths.

    FDA Recall
    Open, Classified ·Energetiq Technology Inc·Product code REK·September 27, 2019

    The MSOT Acuity Echo is a Class 4 medical laser device. The MSOT Acuity is a mobile assembly of electrically-powered components intended for imaging and analysis of soft-tissue and vasculature using combined optoacoustic (photoacoustic) and ultrasound (US) imaging.

    FDA Recall
    Open, Classified ·Ithera Medical Gmbh Zielstattstr. 13 Munich Germany·Product code REK·January 8, 2025

    R&D CBC-3D Hematology Control: (1) CBC-3D Normal Pack Hematology Control, REF 3D501, containing 10 x 2.0mL Control N; (2) CBC-3D TRI PACK Hematology Control, REF 3D503, containing 4 x 2.0 mL Controls L, N, and H; (3) CBC-3D for Mythic 18 Hematology Control, REF 3D503RX, containing 2 x 2.0 mL each Controls L, N, and H; (4) CBC-3D For MINDRAY Hematology Control, REF 3D506, containing 2 x 3.0 mL each Controls L, N, and H; (5) CBC-3D For MINDRAY Hematology Control, REF 3D506US, containing 2 x 3.0 mL each Controls L, N, and H; (6) CBC-3D TRI PACK Hematology Control, REF 3D507, containing 4 x 2.0 mL each Controls L, N, and H; (7) CBC-3D TRI PACK Hematology Control, REF 3D508, containing 2 x 2.0 m each Controls L, N, and H; (8) CBC-3D For ABACUS, REF D3D02 Hematology Control, containing 2 x 3.0 mL each Controls L, N, and H; (9) CBC-3D For ABACUS Hematology Control, REF D3D04, containing 4 x 3.0 mL each Controls L, N, and H. Loose tubes labeled CBC-3D Hematology Control in 2.0mL and 3.0mL sizes. OEM/Own-label distributor labels: (1) Alere 380 Hemo Control (L-N-H), REF AL35004-KIT, containing 2 x 3.0 mL each Controls L, N, and H; Kit lot #B1122; control lot #B1122N, no UDI (2) diatron Diacon 3 Hematology Control, Normal Level, 3.0 mL tubes, lot #B1122N (3) diatron Diacon 3 Hematology Control, REF DN35002-SET, containing 6 x 3.0 mL Control N, kit lot #B1122, control lot #B1122N (4) diatron Diacon 3 Hematology Control, REF DN35004-KIT, containing 2 x 3.0 mL each Controls L, N, and H, kit lot #B1122, Normal control lot #B1122N. (5) Elite 3 HEM Control Normal, REF HEM00014, containing 6 x 3.0 mL Normal controls, kit lot #B1122, control lot #B1122N; (6) Erba H3 CON N, REF HEM00034, 3 mL vials, lot #E1122N, exp. 2023-02-10 (7) Horiba Medical Minotrol 16 Whole Blood Hematology Control, Cat. #5300000277, containing 3 x 2.5mL tubes (1 each Control 1, Control 2 (Normal), and Control 3; Cat. #5300000278, containing 6 x 2.5mL tubes (2 each Control 1, Control 2 (Normal), and Control 3; and Cat. #5300000283, containing 12 x 2.5mL tubes (4 each Control 1, Control 2 (Normal), and Control 3; kit lot #MX438, exp. 2023-01-05, Control 2 lot #MX438N. (8) 2022 3rd Test Event, CBC PLT 3 PART DIFF 2022-912-3D; and 2022 3rd Test Event, CBC PLT 3 PART DIFF 2022-914-3D. (9) mindray BC-3D, P/N 040-001423-00. (10) MINDRAY BC-3D CONTROL, REF BC3D01, containing 1 x 3.0 mL Controls L, N, and H; REF BC3D02, containing 2 x 3.0 mL Controls L, N, and H; and REF BC3D6N, containing 6 x 3.0 mL Control N; kit lot #B1122, control lot #B1122N. (11) MINDRAY BC-3D CONTROL, REF BC3D02US, containing 2 x 3.0 mL Level L, N, and H, kit lot number B1122, control lot #B1122N. (12) Nihon Kohden MEK-3D Hematology Control, REF 3DN03, containing MEK-3DN x 3 tubes; REF 3DN06, containing MEK-3DN x 6 tubes; and REF 3DN12, containing MEK-3DN x 12 tubes, kit lot #B22Y, control lot #B22YN. (13) Nihon Kohden MEK-3DN Normal Hematology Control tubes, 2.0 mL, lot #B22YN. (14) Orphee MYT-3D, REF MYT301, containing 2 x 2.5 mL Control N; REF MYT302, containing 2 x 2.5 mL each Controls L, N, and H; REF MYT304N, containing 4 x 2.5 mL Control N; REF 306N, containing 6 x 2.5 mL Control N; kit lot #B1122, control lot #B1122N; Myt-3D VET, REF MYT303-VET, containing 1 x 2.5 mL each Control L, N, and H. (15) Siemens ADVIA 360 Control, REF 11170853, containing 2 x 3.0 mL each Controls Low, Normal & High, kit lot #B0822, GTIN 00630414600833, control lot #B1122N. (16) URIT HQ-3DIFF, REF 5411000306, containing 2 x 3.0 mL each Controls L, N, and H, kit lot #B1122, control lot #B1122N; URIT HQ-3DIFF Hematology Control N tubes, 3.0 mL, lot #B1122N. (17) Woodley Haematology Control, REF WD1154, containing 6 x 2.0 mL Control N; and REF WD1154A, containing 2 x 2.0 mL each Controls L, N, and H, kit lot number B1122, control lot #B1122N;

    FDA Recall
    Open, Classified ·R & D Systems, Inc.·Product code JPK·November 7, 2022

    EcoGel 100 - RED Medical Supplies Green Ultrasound Gel, Model No. 250UG-GLU

    FDA Recall
    Open, Classified ·Red Medical Supplies·Product code ITX·August 11, 2021

    EcoGel 200 - RED Medical Supplies Blue Ultrasound Gel, Model No. 250UG-BMU

    FDA Recall
    Open, Classified ·Red Medical Supplies·Product code ITX·August 11, 2021

    EcoGel 200 - RED Medical Supplies Clear Ultrasound Gel, Model No. 250UG-CMU

    FDA Recall
    Open, Classified ·Red Medical Supplies·Product code ITX·August 11, 2021

    Mito Red Light, Super Mobile

    FDA Recall
    Open, Classified ·MITO RED LIGHT INC·Product code ILY·February 12, 2025

    ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11319151

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code CEK·July 29, 2024

    Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11097543

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code CEK·July 29, 2024

    Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543.

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code CEK·August 11, 2025

    Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11319151

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code CEK·September 20, 2021

    Atellica CH Total Protein II- In vitro diagnostic use in the quantitative determination of total protein in human serum and plasma (lithium heparin) using the Atellica CH Analyzer. SMN: 11097604

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code CEK·January 27, 2023

    Pink Luminous Breast, Breast transilluminator

    FDA Recall
    Open, Classified ·Silkprousa LLC·Product code LEK·May 20, 2024

    Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11097543

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code CEK·September 20, 2021

    Brand Name: PALACOS Product Name: PALACOS MV pro 40; PALACOS MV pro 80 Model/Catalog Number: 5150633; 5150635 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). Component: N/A

    FDA Recall
    Open, Classified ·Heraeus Medical GmbH (Dental Division) Philipp-Reis-Str. 8 Wehrheim Germany·Product code LOD·December 9, 2025

    Heraeus, PALAMIX uno. Material Number: 66057893.

    FDA Recall
    Open, Classified ·Heraeus Medical GmbH (Dental Division) Philipp-Reis-Str. 8 Wehrheim Germany·Product code JDZ·March 25, 2026

    Brand Name: PALACOS Product Name: PALACOS R+G pro 40; PALACOS R+G pro 80 Model/Catalog Number: 5081288; 5081289 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). Component: N/A

    FDA Recall
    Open, Classified ·Heraeus Medical GmbH (Dental Division) Philipp-Reis-Str. 8 Wehrheim Germany·Product code LOD·December 9, 2025

    Brand Name: PALACOS Product Name: PALACOS R pro 40; PALACOS R pro 80 Model/Catalog Number: 5081286; 5081287 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). Component: N/A

    FDA Recall
    Open, Classified ·Heraeus Medical GmbH (Dental Division) Philipp-Reis-Str. 8 Wehrheim Germany·Product code LOD·December 9, 2025

    Heraeus, PALAMIX duo. Material Number: 66057897.

    FDA Recall
    Open, Classified ·Heraeus Medical GmbH (Dental Division) Philipp-Reis-Str. 8 Wehrheim Germany·Product code JDZ·March 25, 2026

    Brand Name: PALACOS Product Name: PALACOS MV+G pro 40; PALACOS MV+G pro 80 Model/Catalog Number: 5081290; 5081291 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). Component: N/A

    FDA Recall
    Open, Classified ·Heraeus Medical GmbH (Dental Division) Philipp-Reis-Str. 8 Wehrheim Germany·Product code LOD·December 9, 2025