BEUDAMED
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    Multitom Rax with True2scale Body Scan Option

    FDA 510(k)
    FDA Class 2 ·Radiology

    NuVasive

    FDA UDI
    Nuvasive, Inc.·00195377046789·NTS Slot Tube, 22x120mm Beveled

    NA

    FDA UDI
    Synthes GmbH·10886982152190·5.0MM LOCKING SCREW SLF-TPNG WITH T25 STARDRIVE...

    ARKEO, Wedge Fixation System

    FDA UDI
    Auxano Medical LLC·00850055649828·ARKEO Evan's Wedge, 22x22x12

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613327090420·2.0 MP LE FORT I PLATE,12MM ADV.,R

    TruPlan

    FDA 510(k)
    FDA Class 2 ·Radiology

    MODIFICATION TO AEQUALIS SHOULDER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TARGET DEVICE 300X160MM /KH12212

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·June 1, 2011

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·August 15, 2011

    OT VERIO2 METER

    FDA Adverse Event
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 30, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 9, 2013

    INRATIO

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·March 19, 2013

    SMARTPHONE ANDROID APP: PUMP CONNECT

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code PKU·July 15, 2025

    MultiDiagnost Eleva w/ Flat Detector, Product codes 708034, 708037, 708038 Product Usage: As a multifunctional I universal imaging application system, General RIF, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications on human patients. This includes the following general areas: Digestive system: Swallowing studies, Oesophagus, Stomach, Small intestine, Colon, Defeacography, ERCP, T-tube cholangiogram, Liver biopsies, Transjugular Intrahepatic Portosystemic Shunts (TIPS) Skeletal system: Bone studies. Urinary system: IVP, Cystograms, Percutaneous, Nephrolithotomy, Nephrostomy tube replacement Reproductive system: Hysterosalpingogram, Vena spermatica, Cavernography Respiratory system: Thorax, Bronchoscopy, Pulmonary biopsies Circulatory system: Venography, Arteriography, Thrombolytic Therapy, Em bolizations, Em bolectomy, IVC filter placement, Dilatations, Stent placement. Various: Arthrograms, Myelograms, Facet joint injections, Discography, Sialography.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·April 3, 2019

    18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer  10041227 & 10789400 S1000  10441701 S2000  10041461 S2000 (Refurb) - 10440017 S3000  10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·May 3, 2017

    The LifeCare Pump Model 4200 PCA Infuser makes possible the practical implementation of patient-controlled analgesia. The health care professional sets the prescribed dose, rates, and limits for the drug to be infused. The infuser can be set to operate in one of three modes: PCA Mode, Continuous Mode, and PCA + Continuous Mode. The LifeCare Pump Model 4200 PCA Infuser is designed with a number of mechanical, electrical, and software safeguards that prevent patient injury or drug abuse.

    FDA Enforcement
    Class II ·Terminated·Hospira Inc.·July 20, 2016