BEUDAMED
    41 results · 17ms · Sources: EU EUDAMED, US FDA

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    Hintermann Series Talar Implant, Left, Size 2 REF 302112

    FDA Recall
    Open, Classified ·DT MedTech, LLC·Product code NTG·March 24, 2026

    VARIPULSE Bi-Directional Ablation Catheter REF D141201. The Field Catheter is indicated for use in catheter based cardiac electrophysiological mapping (stimulating and recording) and, when used for TRUPULSE Generator, for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation. The catheter provides location information when used with the CARTO 3 System.

    FDA Recall
    Open, Classified ·Biosense Webster, Inc.·Product code QZI·January 5, 2025

    ThinPrep CytoLyt Solution. Buffered Cell Wash Solution.

    FDA Recall
    Open, Classified ·Hologic, Inc·Product code LEA·December 12, 2025

    CERENOVUS CEREBASE DA Guide Sheath, Part Numbers: a) GS9080SD; b) GS9090SD; c) GS9095SD; Vascular guide-catheter, single-use

    FDA Recall
    Open, Classified ·Medos International Sarl Chemin Blanc 36 Le Locle Switzerland·Product code QJP·February 2, 2024

    Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.

    FDA Recall
    Open, Classified ·Abiomed, Inc.·Product code OZD·May 18, 2026

    ETHIBOND EXCEL Polyester Suture, REF: 6664H, X425H, X872H, EH7491H. Not sold in US

    FDA Recall
    Open, Classified ·Ethicon, LLC·Product code GAW·December 20, 2024

    PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurosurgical procedures.

    FDA Recall
    Open, Classified ·Ethicon, LLC·Product code GAW·December 20, 2024

    PERMA-HAND Silk Suture, REF: K872H, W723H, 623H, K833H; Perma-hand Silk Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurosurgical procedures.

    FDA Recall
    Open, Classified ·Ethicon, LLC·Product code GAW·December 20, 2024

    PANTHER FUSION System REF 9121010000 The Panther System is an integrated nucleic acid testing system which fully automates all steps necessary to perform Aptima assays from sample processing through amplification, detection, and data reduction. The Panther Fusion System is an integrated, fully automated, in vitro diagnostic (IVD) clinical multiplex test system. It is capable of performing nucleic acid based tests from sample processing through amplification, detection, and data reduction.

    FDA Recall
    Open, Classified ·Hologic, Inc.·Product code OOI·December 15, 2023

    ROSA One 3.1 Brain application The device is intended for the spatial positioning and orientation of instruments holders or tool guides to be used by trained surgeons to guide standard surgical instruments during brain and spine surgeries.

    FDA Recall
    Open, Classified ·MEDTECH SAS 900 Rue Du Mas De Verchant Montpellier France·Product code HAW·September 22, 2021

    Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Model/Catalog Number: CMP-01669 Software Version: N/A - not software version specific Component: Yes, the Genius" Review Station is a component of the Genius" Digital Diagnostics System with the Genius" Cervical AI Algorithm cleared under DEN210035.

    FDA Recall
    Open, Classified ·Hologic, Inc·Product code QYV·March 23, 2026

    CEREPAK Detachable Coil System - Name/REF: UNIFORM 2MM X 2.5 CM/FCX100202, UNIFORM 2.5MM X 3.3 CM/FCX100253, UNIFORM 3MM X 5.4 CM/FCX100305, UNIFORM 3.5MM X 6.6 CM/FCX100356, UNIFORM 4MM X 7.5 CM/FCX100407, UNIFORM 4MM X 11.5 CM/FCX100412, UNIFORM 5MM X 9.7 CM/FCX100509, UNIFORM 5MM X 17 CM/FCX100517, UNIFORM 6MM X 11.9 CM/FCX100611, UNIFORM 6MM X 26 CM/FCX100626, UNIFORM 7MM X 13.9 CM/FCX100713, UNIFORM 7MM X 30 CM/FCX100730, UNIFORM 8MM X 16.1 CM/FCX100816, UNIFORM 8MM X 29 CM/FCX100829, UNIFORM 3D 2MM X 2.5 CM/FCX140225, UNIFORM 3D 3MM X 3 CM/FCX140303, UNIFORM 3D 3MM X 4 CM/FCX140304, UNIFORM 3D 3MM X 6 CM/FCX140306, UNIFORM 3D 4MM X 6 CM/FCX140406, UNIFORM 3D 4MM X 8 CM/FCX140408, UNIFORM 3D 4MM X 4.5 CM/FCX140445, UNIFORM 3D 5MM X 7 CM/FCX140507, UNIFORM 3D 5MM X 12 CM/FCX140512, UNIFORM 3D 6MM X 9 CM/FCX140609, UNIFORM 3D 6MM X 15 CM/FCX140615, UNIFORM 3D 7MM X 11 CM/FCX140711, UNIFORM 3D 7MM X 17 CM/FCX140717, UNIFORM 3D 8MM X 12 CM/FCX140812, UNIFORM 3D 8MM X 20 CM/FCX140820, UNIFORM 3D 9MM X 14 CM/FCX140914, UNIFORM 3D 9MM X 22 CM/FCX140922, UNIFORM 3D 10MM X 16 CM/FCX141016, UNIFORM 3D 10MM X 25 CM/FCX141025, UNIFORM 3D 11MM X 18 CM/FCX141118, UNIFORM 3D 11MM X 27 CM/FCX141127, UNIFORM 3D 12MM X 19 CM/FCX141219, UNIFORM 3D 12MM X 30 CM/FCX141230, UNIFORM XL 5MM X 10 CM/FCX180510, UNIFORM XL 6MM X 12.2 CM/FCX180612, UNIFORM XL 7MM X 14.3 CM/FCX180714, UNIFORM XL 8MM X 13.6 CM/FCX180813, UNIFORM XL 8MM X 30 CM/FCX180830, UNIFORM XL 9MM X 15.3 CM/FCX180915, UNIFORM XL 9MM X 33 CM/FCX180933, UNIFORM XL 10MM X 17.1 CM/FCX181017, UNIFORM XL 10MM X 34 CM/FCX181034, UNIFORM XL 11MM X 18.9 CM/FCX181118, UNIFORM XL 11MM X 37 CM/FCX181137, UNIFORM XL 12MM X 20.7 CM/FCX181220, UNIFORM XL 12MM X 40 CM/FCX181240, UNIFORM XL 13MM X 43 CM/FCX181343, UNIFORM XL 14MM X 47 CM/FCX181447, UNIFORM XL 15MM X 50 CM/FCX181550, UNIFORM XL 16MM X 47 CM/FCX181647, UNIFORM XL 17MM X 50 CM/FCX181750, UNIFORM XL 18MM X 46 CM/FCX181846, UNIFORM XL 19MM X 50 CM/FCX181950, UNIFORM XL 20MM X 50 CM/FCX182050, FREEFORM MINI 1MM X 1CM/MCR091010, FREEFORM MINI 1MM X 1.5CM/MCR091015, FREEFORM MINI 1MM X 2CM/MCR091020, FREEFORM MINI 1MM X 2.5CM/MCR091025, FREEFORM MINI 1MM X 3CM/MCR091030, FREEFORM MINI 1MM X 4CM/MCR091040, FREEFORM MINI 1.5MM X 2CM/MCR091520, FREEFORM MINI 1.5MM X 2.5CM/MCR091525, FREEFORM MINI 1.5MM X 3CM/MCR091530, FREEFORM MINI 1.5MM X 4CM/MCR091540, FREEFORM MINI 2MM X 2CM/MCR092020, FREEFORM MINI 2MM X 3CM/MCR092030, FREEFORM MINI 2MM X 4CM/MCR092040, FREEFORM MINI 2MM X 6CM/MCR092060, FREEFORM MINI 2.5MM X 3.5CM/MCR092535, FREEFORM MINI 2.5MM X 4.5CM/MCR092545, FREEFORM MINI 2.5MM X 5.5CM/MCR092555, FREEFORM MINI 3MM X 4CM/MCR093040, FREEFORM MINI 3MM X 6CM/MCR093060, FREEFORM MINI 3MM X 8CM/MCR093080, FREEFORM 2MM X 2 CM/SCR120202, FREEFORM 3MM X 6 CM/SCR120306, FREEFORM 3MM X 8 CM/SCR120308, FREEFORM 4MM X 7 CM/SCR120407, FREEFORM 4MM X 10 CM/SCR120410, FREEFORM 4MM X 12 CM/SCR120412, FREEFORM 5MM X 10 CM/SCR120510, FREEFORM 5MM X 15 CM/SCR120515, FREEFORM 6MM X 10 CM/SCR120610, FREEFORM 6MM X 15 CM/SCR120615, FREEFORM 6MM X 20 CM/SCR120620, FREEFORM 7MM X 15 CM/SCR120715, FREEFORM 7MM X 21 CM/SCR120721, FREEFORM 8MM X 15 CM/SCR120815, FREEFORM 8MM X 24 CM/SCR120824, FREEFORM 9MM X 25 CM/SCR120925, FREEFORM 10MM X 30 CM/SCR121030, FREEFORM 12MM X 30 CM/SCR121230, FREEFORM 2.5MM X 5 CM/SCR122505, FREEFORM 2.5MM X 3.5 CM/SCR122535, FREEFORM 3.5MM X 9 CM/SCR123509, FREEFORM 3.5MM X 7.5 CM/SCR123575, HELIFORM SOFT 1.5MM X 4 CM/SHD100154, HELIFORM SOFT 2MM X 8 CM/SHD100208, HELIFORM SOFT 2.5MM X 10 CM/SHD100250, HELIFORM SOFT 2.5MM X 8 CM/SHD100258, HELIFORM SOFT 3MM X 8 CM/SHD100308, HELIFORM SOFT 3MM X 10 CM/SHD100310, HELIFORM SOFT 4MM X 8 CM/SHD100408, HELIFORM SOFT 4MM X 10 CM/ SHD100410, HELIFORM SOFT 5MM X 10 CM/ SHD100510, HELIFORM SOFT 5MM X 15 CM/ SHD100515, HELIFORM SOFT 6MM X 12 CM/ SHD100612, HELIFORM SOFT 6MM X 16 CM/ SHD100616, HELIFORM SOFT 7MM X 16 CM/ SHD100716, HELIFORM SOFT 7MM X 20 CM/ SHD100720, HELIFORM SOFT 8MM

    FDA Recall
    Open, Classified ·Cerenovus Inc·Product code HCG·October 2, 2025

    MEDITECH Expanse Laboratory (LAB), Microbiology (MIC), Anatomical Pathology (PTH), Genetics (GEN). Calculator/data processing module for clinical use.

    FDA Recall
    Open, Classified ·Medical Information Technology, Inc.·Product code JQP·February 5, 2025

    Products are labeled as: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) 20 TESTS/1 KIT Green and white box under the brand DiagnosUS, and, White box without brand name labeled as "SARS -COV-2 ANTIGEN DEVELOPMENT MADE IN USA ORAL SWAB TESTING

    FDA Recall
    Open, Classified ·Universal Meditech Inc.·Product code QKP·November 28, 2022

    PrestiBio Rapid Detection Pregnancy Test Midstream REF 100-17 3 TESTS

    FDA Recall
    Open, Classified ·Universal Meditech Inc.·Product code LCX·May 22, 2023

    HealthyWiser pH-Aware pH 4.5 - 9.0 pH Test Strips REF 900-1P 120 STRIP

    FDA Recall
    Open, Classified ·Universal Meditech Inc.·Product code CEN·May 22, 2023

    PrestiBio BREAST MILK ALCOHOL TEST STRIP REF 910-10 25 TESTS

    FDA Recall
    Open, Classified ·Universal Meditech Inc.·Product code ORA·May 22, 2023

    Am I Pregnant? One Step HCG Pregnancy Test REF 100-17

    FDA Recall
    Open, Classified ·Universal Meditech Inc.·Product code LCX·May 22, 2023

    Lem Fertility hCG Pregnancy Urine Test REF 100-12

    FDA Recall
    Open, Classified ·Universal Meditech Inc.·Product code JHI·May 22, 2023

    HealthyWiser UriTest" UTI Test Strips REF 900-UTI

    FDA Recall
    Open, Classified ·Universal Meditech Inc.·Product code NGJ·May 22, 2023