BEUDAMED
    20 results · 13ms · 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 ×

    VIDAS Lyme IgG II (LYM), REF 417401

    FDA Recall
    Open, Classified ·bioMerieux, Inc.·Product code LSR·September 22, 2021

    VIDAS Lyme IgM II (LYM), REF 416436

    FDA Recall
    Open, Classified ·bioMerieux, Inc.·Product code LSR·September 22, 2021

    Box Label: activ5 TINY GYM IN YOUR POCKET activbody Model: Activ5 User Manual: ACTIV5 USER MANUAL Welcome to Activ5, the first isometrics-based smart strength training and rehabilitation device.

    FDA Recall
    Open, Classified ·Activbody, Inc.·Product code LBB·November 30, 2021

    MIM software; System, Image Processing, Radiological

    FDA Recall
    Open, Classified ·MIM Software Inc·Product code LLZ·February 19, 2025

    The product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm range.

    FDA Recall
    Open, Classified ·IN MY BATHROOM LLC·Product code RHP·January 27, 2022

    Medline Convenience kits used for various procedures: 1) NAIL PACK, Model Number: SUT15830A;

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code MDM·March 3, 2025

    Brand Name: HiResolution" Bionic Ear System Product Name: M Zn-Air Battery Pak Model/Catalog Number: CI-5501-110; CI-5501-120; CI-5501-130; CI-5501-140; CI-5501-150; CI-5501-190; CI-5501-240; CI-5501-250; CI-5501-260; CI-5501-270; CI-5501-280 Software Version: Not Applicable Product Description: The M Zn-Air Battery Pak is a disposable power source for the Naida" CI M and Sky CI" M Sound Processors. The type of disposable battery to be used with the M Zn-Air Battery Pak is a 675 power implant battery (P675). Regular 675 hearing instrument batteries will not be powerful enough for a cochlear implant. The suggested manufacturer and battery is PowerOne P675 Implant Plus battery. The M Zn-Air Battery Pak is available with non-tamperproof and tamperproof cartridges. Component: Not Applicable

    FDA Recall
    Open, Classified ·Advanced Bionics, LLC·Product code MCM·March 23, 2026

    Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28 S-Vector; c) 39547, FLEX26 S-Vector; Cochlear Implant

    FDA Recall
    Open, Classified ·MED-EL Elektromedizinische Gereate, Gmbh Furstenweg 77a Innsbruck Austria·Product code MCM·April 18, 2024

    HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607

    FDA Recall
    Open, Classified ·Advanced Bionics, LLC·Product code MCM·March 5, 2025

    Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150

    FDA Recall
    Open, Classified ·Advanced Bionics, LLC·Product code MCM·November 27, 2025

    9 Gauge Disposable Trocars with Blunt Pushers for Use with Subcutaneous Implants Part Number: 50134-01

    FDA Recall
    Open, Classified ·ENDO Pharmaceuticals Solutions, Inc.·Product code MDM·November 8, 2022

    Sterile Procedural Trays, labeled as the following: IM NAIL

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code MDM·November 17, 2022

    Centurion STERILE #16 RUBBER BAND, Product Code EB16

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code MDM·February 23, 2024

    Epix Universal Clip Applier, REF: CA500, STERILEEO

    FDA Recall
    Open, Classified ·Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa·Product code MDM·January 30, 2024

    Trumpet, Needle Guide, Cat# TMS-200

    FDA Recall
    Open, Classified ·Technicality Inc.·Product code MDM·January 31, 2024

    Brand Name: HiResolution" Bionic Ear System Product Name: HiRes Ultra 3D CI HiFocus Mid Scala Model/Catalog Number: CI-1601-04 Software Version: N/A Product Description: The HiResolution Bionic Ear System is a cochlear implant designed to provide useful hearing to individuals with severe-to-profound hearing loss. It consists of internal and external components. The internal components include the HiRes" Ultra 3D receiver and either the HiFocus" SlimJ electrode or the HiFocus" Mid-Scala (MS) electrode array that are implanted surgically under the skin behind the ear. The external components include a sound processor (body-worn or ear-level), a headpiece, and a cable. The system converts sound into electrical energy that activates the auditory nerve. The auditory nerve then sends information to the brain, where it is interpreted as sound. Component: N/A

    FDA Recall
    Open, Classified ·Advanced Bionics, LLC·Product code MCM·April 30, 2026

    Epix Universal Clip Applier, REF: CA500, STERILEEO included within the following kit Reference Numbers: GK1003, AME Kit 54562 GK1004, KIT LAP CHOL DEN HOED 2, GK1005, K2550 - HPATECTOMIE ERASME, GK1011, K-19459, GK1014, K-18031 STANDARD KIT, GK1018, K-20735 STANDARD KIT, GK1033, AME STANDARD KIT 21-023, GK1044, KE39830 COLE, GK1047, AME STANDARD KIT 22-003, GK1063, AME STANDARD KIT 22-022, GK1068, AME STANDARD KIT 22-027, GK1071, AME STANDARD KIT 22-030, GK1083, AME STANDARD KIT 22-045, GK1094, AME STANDARD KIT 23-015, GK1096, AME STANDARD KIT 23-017, GK1101, AME STANDARD KIT 23-033, GK131, LAP CHOLE PROCEDURE PACK, GK153, TOTAL 5mm SOLUTION KIT 11, GK168, 10mm ACCESS/LIGATION/RETRIEVAL PK, GK258, AME STANDARD KIT 44, GK260, STANDARD SET 360 Z, GK307, CHOLE KIT 1, GK308, CHOLE KIT 15, GK320, CHOLE KIT 24, GK358, CHOLE KIT 22, GK360, CHOLE KIT 18, GK363, CHOLE KIT 31, GK364, CHOLE KIT 30, GK365, CHOLE KIT 28, GK368, CHOLE KIT 33, GK401, TOTAL 5mm SOLUTION KIT 41, GK402, TOTAL 5mm SOLUTION KIT 42, GK736, LAP. CHOLECYST. CLIP, GK738, STANDARD SET 112 F, GK739, STANDARD SET 397 F, GK834, K100796, GK835, KIT AME 55003, GK837, KIT K86656, GK857, KIT CHOLECYSTECTOMIE LOBBES, GK858, KIT KE284, GK861, KIT VESICULE 11MM CHA, GK874, LAP CHOLE KIT Z-THREAD, GK877, LAP CHOL KIT 5, GK878, SSMC LAP, CHOLE, KIT NO.1, GK879, SSMC LAP, CHOLE, KIT NO. 2, GK891, LAP-GALLE-SET, GK895, KIT HERES LAP CHOL 5MM, GK905, GALLKIT TORSBY SJUKHUS, GK920, K57569, GK921, K57526, GK924, K65251, GK962, LAP CHOL BOOM, GK965, URO- VARIKOCELEN+LYMPHEKTOMIESET, GK969, KIT LAP CHOL TOORENVLIET, GK980, KE78892 LAP PROSTATECTOMY 2, GK983, KIT KE 111515, GK987, LAP. CHOLE-SET LKH MURTAL, GK988, LAPCHOLE KIT ERASME VERSION 4, GK992, K8056 - KIT COLE, GK993, K116634, GK998, GALLEKIT VOSS, JK001, OLYMPUS KIT 1 (2XCTF03,1XCA500), JK003, OLYMPUS KIT 3 (2XCFF05, 1XCA500), JK004, OLYMPUS KIT 4 (2XCTR05, 1XCA500), K0880, DR. THAMES-LAP CHOLE, K0924, DR. COMPTON'S LAP CHOLE PACK, K2212, DR. MILLER LAP CHOLE KIT, K2440, LAP CHOLE KIT, K2607, BORLAND GASTRIC SLEEVE, K2640, LAP CHOLE KIT, K2656, SOUTH SUNFLOWER LAP CHOLE KIT, K2703, DR. AZAR LAP CHOLE PACK, K2705, DRS.GIROD & INGRAM LAP CHOLE PACK, K2797, LAP CHOLE PROCEDURAL PACK 1, K2903, LAP CHOLE KIT, K2922, KIT CLIP APPLIER, K2924, CLIP KIT A, K2925, CLIP KIT F, K2926, CLIP KIT F, K2927, CLIP KIT B, K2928, LAP CHOLE KIT, K2929, LAP CHOLE KIT, K2933, AM MENAT KIT # 0001, K2934, AM MENAT KIT # 0002

    FDA Recall
    Open, Classified ·Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa·Product code MDM·January 30, 2024

    Small Joint OATS Set, REF AR-8981-06S, 6mm; and Small Joint OATS Set, REF AR-8981-08S, 8mm, both containing a cannulated reamer, sterile.

    FDA Recall
    Open, Classified ·Arthrex, Inc.·Product code MDM·November 2, 2022

    Medline Convenience kits, labeled as: GAMMA NAIL CDS-LF , Pack Number CDS983505K

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code MCM·April 8, 2024

    ECONO STERILE medical procedure kits labeled as: ECONO STERILE SCHAMBERG EXTRCT SQ STER CS25, Model Number 96-2395M; blackhead extractor

    FDA Recall
    Open, Classified ·Sklar Instruments·Product code MDM·December 3, 2024