BEUDAMED
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    E-Z CHEK BLOOD LEAK TEST STRIPS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    General Instrument

    FDA UDI
    ALPHATEC SPINE, INC.·00840180515532·Osteotome, Straight, 5mm

    CASCADIA™ Interbody System

    FDA UDI
    VB Spine LLC·10888857554597·Trial Size 14x18x10 mm, Convex

    MEDICAL WIRE & EQUIPMENT S-TRANSWAB (OR SIGMA-TRANSWAB) LIQUID AMIES COLLECTION AND TRANSPORT DEVICE

    FDA 510(k)
    FDA Class 1 ·Microbiology

    LAERDAL PAEDIATRIC POCKET MASK, MODEL 820050

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    NEEDLE SPINAL S/SU 18GA 6IN QUINCKE

    FDA Adverse Event
    Injury ·BD CARIBE LTD.·Product code BSP·February 4, 2020

    MEDTRONIC PS MEDICAL INTRODUCER SHEATH 12F,14F,15F, MODELS 3805-012, 3805-014, 3805-015

    FDA 510(k)
    FDA Class 2 ·Neurology

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 22, 2013

    ATTAIN OTW

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 14, 2011

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM VG

    FDA Adverse Event
    Malfunction ·COSTA RICA·Product code LTI·August 14, 2008

    MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

    Depuy P.F.C. E knee system, all polyethylene curved tibial component, Sz 1.5, 15 mm; Ref 96-0613.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code NJL·May 26, 2005

    Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05

    FDA Enforcement
    Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016