BEUDAMED
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    DUPONT 'ACA' CREATINE KINASE VERIFIERS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Signature III

    FDA UDI
    Rmo, Inc.·00885797101938·SIG III MBT.022 HK EXT 1 CS

    JOBST Relief

    FDA UDI
    BSN MEDICAL, INC.·04042809156973·RELIEF 20-30 MM HG CHAP LEFT OPEN TOE LARGE BEI...

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515211803·Micro Iris Sci, sm, very sharp blades, cvd

    Symmetry Metzenbaum

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482127032·Symmetry® Scissors, Metzenbaum Baby, Straight, ...

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756087254·BLUE ARM SLING

    PC

    FDA UDI
    Allied Medical, LLC·00026072016114·COUPLER MALE DISS TO STEM 1/4"

    PEDIATRIC INGESTASCAN

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    POWDER FREE NITRILE EXAMINATION GLOVES, STERILE WITH CHEMOTHERAPY CLAIM

    FDA 510(k)
    FDA Class 1 ·General Hospital

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·May 9, 2014

    COAPTITE INJECTABLE IMPLANT

    FDA Adverse Event
    Other ·MERZ AESTHETICS, INC.·Product code LNM·October 17, 2012

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 17, 2010

    InnoWave Sonic Irrigator, There are currently six models (PCF, Pro, Ultra, Ultra+, Unity, and ECO) - Product Usage: STERIS InnoWave Sonic Irrigators are intended to thoroughly clean (remove tissue, blood, and other contaminants from) a variety of reusable surgical instruments. The equipment provides sonic irrigation (ultrasonic cavitation) to both interior and exterior of lumened instruments.

    FDA Enforcement
    Class II ·Terminated·Steris Corporation·August 5, 2020

    smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

    Current, Sterile EO, Model #/ Part #: 1207-30/50020236-001, 60010739-207, 60010739-407; 1207-36/50020237-001, 60010742-207, 60010742-307, 60010742-407, 60010742-707; 2207-30/ 50020238-001, 60010738-207; 2207-36/ 50020239-001, 60010741-207, 60010741-307, 60010741-407, 60010741-707; CD1211-36/100006983, 100012542, 100016679, 100031495, 100035634, 100035635, 100042587, 100047090; CD1211-36Q/100004079, 100004081, 100019783, 100035607, 100042591, 100047191; CD1215-36/100006990, 100010230, 100010241, 100010242, 100010244, 100012563, 100012564, 100034631, 100046574, 100046786; CD1215-36Q/100006768, 100006769, 100006770, 100023300, 100030306, 100033794, 100042402, 100046720, 100046904; CD1217-36/100011824; CD1219-36/100002160, 100002864, 100011826; CD1219-36Q/100004071, 100023301; CD2211-36/100006982, 100012536, 100016678, 100031440, 100035629, 100035636, 100042520, 100047192; CD2211-36Q/100004085, 100004087, 100019782, 100035587, 100042575, 100047193; CD2215-36/100006992, 100010224, 100010226, 100010227, 100010228, 100012515, 100012516, 100036606, 100046676, 100046792, 60019063; CD2215-36Q/100006762, 100006763, 100006764, 100023302, 100029180, 100033793, 100042404, 100046789, 100046905; CD2217-36/100011828, 100046991, 60016124-401; CD2219-36/100002139, 100002140, 100002862, 100011830; CD2219-36Q/100023303

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018