BEUDAMED
    21 results · 19ms · Sources: EU EUDAMED, US FDA

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    VITROS IMMUNODIAGNOSITCS PRODUCTS-FREE T3 REAGENT PACK (GEM.1020)/FREE T3 CALIBRATORS (GEM.C020)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    artegral

    FDA UDI
    Merz Dental GmbH·D7091970016·anteriors; shade A1; mould ITL

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690190134·GRADUATED TIBIAL SCREW DRILL

    Paltop

    FDA UDI
    PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108697353·PAI Dental Implant Ø5mm L16mm

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR89700161·Mand. 2. Molar band W-Fit right 16

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR89700160051·Mand. 2. Molar band W-Fit right 16

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR89700160501·Mand. 2. Molar band W-Fit right 16

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR89700160101·Mand. 2. Molar band W-Fit right 16

    Biodesign Fistula Plug

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    BLUE SHARK

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NexGen®

    FDA UDI
    Zimmer, Inc.·00889024214170·

    NexGen®

    FDA UDI
    Zimmer, Inc.·00889024214163·

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·February 20, 2013

    SARA PLUS SLING

    FDA Adverse Event
    Malfunction ·ARJOHUNTLEIGH GETINGE GROUP·Product code FSA·January 21, 2011

    14CM ANGLE ATTACHEMENT

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·December 11, 2013

    ZENITH® TX2® TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT

    FDA Adverse Event
    Injury ·WILLIAM COOK EUROPE·Product code MIH·August 8, 2018

    NEXGEN CRUCIATE RETAINING ARTICULAR SURFACE

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·August 16, 2016

    CR PRECOAT FEM COMP SIZE BMR CR PRECOAT FEM COMP SIZE C/R CR PRECOAT FEM COMP SIZE D/R CR PRECOAT FEM COMP SIZE E/R CR PRECOAT FEM COMP SIZE F/R CR PRECOAT FEM COMP SIZE G/L CR PRECOAT FEM COMP SIZE H/L CR PRECOAT FEM COMP SIZE H/R CR POROUS FEM COMP SIZE E/L CR POROUS FEM COMP SIZE H/R This device is indicated for patients with severe knee pain and disability

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·March 21, 2018

    NexGen Knee CR Porous FEM NexGen Knee CR 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

    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