BEUDAMED
    19 results · 26ms · Sources: EU EUDAMED, US FDA

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    MYCOPLASMA PNEUMONIAE ANTIBODY TEST SYSTEM

    FDA 510(k)
    FDA Class 1 ·Microbiology

    NP Natural Profile Abutment 4.0mm x 2.0 mm

    FDA UDI
    STERNGOLD DENTAL LLC·00841549111662·The WP Natural Profile Abutment System is attac...

    Marking Pen

    FDA UDI
    KATENA PRODUCTS, INC.·00841668114377·MARKING PEN BROAD (PK/10)

    PERPOS PLS SYSTEM, Single Implant

    FDA UDI
    INTERVENTIONAL SPINE, INC·81195401000324·1 Bone-Lok PLS Implant

    Boss Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515230804·Kerrison Bone Rong, sz #1, 4.0mm bite

    FLOCARE N

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    CORPAK GASTROSTOMY TUBE

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

    DISPOSABLE POSTERIOR LUMBAR STABILIZATION PROCEDURE KIT, MODELS 9045-01 AND 9045-02; COMPRESSION TOOL, MODEL 6113-00

    FDA 510(k)
    FDA Unclassified ·Unknown

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·November 22, 2010

    FLEXTEND

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code DTB·July 1, 2014

    SECURE 3 MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·November 30, 2012

    Single Use PERPOS PLS System, Catalog #9045-01 Catalog#9045-01 for Single Use PERPOS PLS System- a sterile, medical device kit consisting of the components: PERPOS Access Needle, PERPOS K-Wires, PERPOS 2-in-1 Drill, PERPOS Tap, PERPOS Device Driver, 4.5mm BONE-LOK PLS Implant, and PERPOS Pull Pin Remover. The kit is used by medical professions to stablize the spine as an aid to fusion through immobilization of the facet joints.

    FDA Recall
    Terminated ·Interventional Spine Inc·Product code HTW·February 22, 2008

    PERPOS PLS System, Single Use; CATALOG #'s 9045-01 & 9045-02. Interventional Spine, Inc. A sterile kit used to stabilize the spine as an aid to fusion through immobilization of the facet joints.

    FDA Recall
    Terminated ·Interventional Spine Inc·Product code HXX·February 3, 2011

    PERPOS 2-in-1 Drills, Catalog #6070 Component Part #6070 for PERPOS 2-in-1 Drill-a canulated, 2 step drill to be used over a K-wire to remove bone prior to the 4.5mm BONE-LOK PLS Implant (LSW-45-3040) being placed. The PERPOS 2-in-1 Drill (6070) is sold as either a component of the Single Use PERPOS PLS System (9045-01, 9045-02) or as a stand-alone tool.

    FDA Recall
    Terminated ·Interventional Spine Inc·Product code HTW·February 22, 2008

    PERPOS Driver; Catalog # 6112 Interventional Spine, Inc. A cannulated, driver to be used over a K-wire to engage the head of the 4.5mm BONE-LOK PLS Implant (LSW-45-3040) and drive it into the bone. The PERPOS Driver (61 12) is sold as either a component of the Single Use PERPOS PLS System (9045-01, 9045-02), a component of the Reusable BONE-LOK PLS System (9039-01, 9039-02), or as a stand-alone tool.

    FDA Recall
    Terminated ·Interventional Spine Inc·Product code HXX·February 3, 2011

    PERPOS PLS, CATALOG #'s 9045-01 & 9045-02 A sterile, medical device kit consisting of the components listed in Table 1-1 below. The kit is used by medical professionals to stabilize the spine as an aid to fusion through immobilization of the facet joints.

    FDA Recall
    Terminated ·Interventional Spine Inc·Product code MRW·March 15, 2011

    Catalog # 9024-00 or LSW-S-3040 for 4.5mm BONE-LOK PLS Implant A sterile, canulated screw that is supplied as a stand-alone product. The 4.5mm BONE-LOK PLS Implant is also supplied as a component of the Single Use PERPOS PLS System (9045-01 and 9045-02). The labeling and instructions for use for the 4.5mm BONE-LOK PLS a Implant (9024-00) are provided in Appendix C.

    FDA Recall
    Terminated ·Interventional Spine Inc·Product code MRW·March 15, 2011

    PERPOS PLS SYSTEM, CATALOG NO. 9045-01 A sterile, medical device kit consisting of the components listed in Table 1-1 below. The kit is used by medical professionals to stabilize the spine as an aid to fusion through immobilization of the facet joints. A Surgical Technique brochure is provided in Appendix A and other labeling, including instructions for use, is provided in Appendix B.

    FDA Recall
    Terminated ·Interventional Spine Inc·Product code HXI·March 23, 2011

    Philips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (REF): 781356. 2. Model Number (REF): 782109. 3. Model Number (REF): 782138. 4. Model Number (REF): 782160.

    FDA Enforcement
    Class II ·Ongoing·Philips North America·May 6, 2026