BEUDAMED
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    REVERE STABILIZATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Puritan Bennett

    FDA UDI
    Covidien LP·20884521134352·Flex Tube Assembly,For Soft Headgear CPAP Inter...

    VACCESS LT LONG-TERM HEMODIALYSIS CATHETER PLUS

    FDA UDI
    Bard Access Systems, Inc.·00801741010903·VACCESS PLUS, ST, 16 FR. 35cm

    AGXO

    FDA UDI
    Oticon A/S·05707131260079·H110, MINIBTE 312 WL 85 SIL AGXO

    BRIVO NM 615

    FDA 510(k)
    FDA Class 2 ·Radiology

    BD VACUTAINER SAFETY-LOK ADMINISTRATION SET WITH FILTER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    T:SLIM G4 SYSTEM

    FDA Adverse Event
    Injury ·TANDEM DIABETES CARE·Product code OYC·July 3, 2017

    ZERO-P VA LORDOTIC H6 PEEK

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code OVE·May 29, 2013

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    FDA Adverse Event
    Death ·MEDTRONIC IRELAND·Product code NIQ·June 14, 2011

    PUMP MMT-522CAS PRDGM INS V2.2 SK EN PR

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·August 22, 2008

    Azurion 5 M12; System Code: (1)722227, (2)722231;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    CIVCO Biopsy Starter Kit, Reusable non-sterile bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REFs 10787043, 11001906, 11001906(CMI), 613-247, 613-247(CMI), 620-116, 639-014, 639-016, 639-021, 639-024, 639-025, 639-026, 639-027, 639-033, 639-035, 639-047, 639-051, 658-001, 667-106, 667-106(CMI), 667-127, 672-001, 698-007, 698-009, 698-013, 698-015, 742-397-T, 742-416, and H48392LT. Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.

    FDA Enforcement
    Class II ·Terminated·Civco Medical Instruments Co. Inc.·November 25, 2015

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015