BEUDAMED
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    Surgical Face Mask

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

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772777525·LUMBAMED PLUS FLEX PAD M SILVER V

    Epimed

    FDA UDI
    EPIMED INTERNATIONAL, INC·00818788020697·22g RW x 3.5" Bella-D® Coudé® Needle

    Fibula Plate Distal, 5-Hole

    FDA UDI
    I.T.S. GmbH·09120069817089·Fibula Plate Distal, 5-Hole, Right

    Stryker

    FDA UDI
    Provision·B504TQ59212122350·

    N/A

    FDA UDI
    STRYKER SUSTAINABILITY SOLUTIONS, INC.·00885825016289·Tourniquet Color Cuff Dual Port, Single Bladder...

    Color Cuff

    FDA UDI
    STRYKER CORPORATION·07613154599714·Disposable Tourniquet Cuff Single Bladder, Dual...

    DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER

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

    AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Stryker Tourniquet

    FDA UDI
    RENU MEDICAL, INC·00816317022716·Stryker Color Cuff II Ped 12x3.5in. 5921-212-235

    OT VERIO IQ METER

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

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·August 15, 2011

    OT VERIO IQ METER

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

    ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model numbers: 10041461, 10440017 -S2000 system 10441730 -S3000 system VTIQ Option- 10439521 and 10439522 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.·August 5, 2015

    Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.

    FDA Enforcement
    Class II ·Terminated·Stryker Sustainability Solutions·November 9, 2016

    DRX Revolution Mobile X-Ray System

    FDA Enforcement
    Class II ·Ongoing·Carestream Health, Inc.·December 13, 2023