BEUDAMED
    18 results · 24ms · 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 ×

    CONTINENTAL 45 TORIC SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Medtronic Reusable Instruments

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00763000703783·CAM SPREADER TRIAL 3990011 0 DEG 11MM

    VENTRALIGHT

    FDA UDI
    Davol Inc.·00801741130977·Ventralight ST Mesh with Echo 2 Positioning Sys...

    Medtronic Reusable Instruments

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169056008·CAM SPREADER TRIAL 3990011 0 DEG 11MM

    ReLine

    FDA UDI
    Nuvasive, Inc.·00195377080318·RELINE C Driver, Stab-n-Grab

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690196518·AK3 Tibial Cutting Block - Left

    Pro-Retractor Round Ring

    FDA UDI
    KOROS U.S.A., INC.·10840199542168·Pro-Retractor Round Ring Medium 10-1/2"

    Mariner Outrigger

    FDA UDI
    Seaspine Orthopedics Corporation·10889981172404·IMPLANT INSERTER, TOP LOADING

    Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    STIMULATOR, MENTOR 100 NERVE

    FDA 510(k)
    FDA Class 2 ·Neurology

    VENTRALIGHT ST W/ ECHO 2

    FDA Adverse Event
    Malfunction ·DAVOL INC., SUB. C.R. BARD, INC. -1213643·Product code FTL·October 20, 2022

    PULSE GEN MODEL 103

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·March 5, 2013

    RENAL - DISPOSABLE

    FDA Adverse Event
    Injury ·Product code KDJ·February 15, 2011

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Malfunction ·MPRI·Product code LWS·August 7, 2014

    VENTRALIGHT ST W/ ECHO 2

    FDA Adverse Event
    Malfunction ·DAVOL INC., SUB. C.R. BARD, INC. -1213643·Product code FTL·October 20, 2022

    VENTRALIGHT ST W/ ECHO 2

    FDA Adverse Event
    Malfunction ·DAVOL INC., SUB. C.R. BARD, INC. -1213643·Product code FTL·October 20, 2022

    Medical convenience kits Item Number/Description EVLH67F LEFT HEART CATH PACK FDCL22R CATH LAB ANGIO IHCC03X CATH CARDIAC PACK TNCC02AD CARDIAC CATH TRINITY UICC27AG CARDIAC CATH ANGIO PACK (PS 923077) UIRD89AH RADIAL PACK (PS 56573)

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems Inc.·October 22, 2025

    NexGen Knee CR Option Fem NexGen Knee CR Porous Fem NexGen Knee CR Precoat Fem NexGen Knee LPS Porous Fem NexGen Knee LPS Precoat Fem prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer various sizes This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collagen disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. " CR and LPS porous coated femoral and tibial baseplate components may be used cemented or uncemented (biological fixation). The CR Hydroxyapatite/tricalcium phosphate [HA/TCP] coated femoral or tibial baseplate components may only be used uncemented. All other femoral, tibial baseplate and all-polyethylene patella components are indicated for cemented use only."

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·March 2, 2016