BEUDAMED
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    CARBON DIOXIDE CUP REAGENT & REF.RGT.

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DUALX DUAL PORTAL MICRO PITUITARY UP 2.0mm

    FDA UDI
    AMPLIFY SURGICAL, INC.·B70708002180·MICRO PITUITARY UP 2.0mm

    NBAC 1.5T SMS, Spine

    FDA UDI
    LMT Medical Systems GmbH·04260486610629·No description.

    Mini Tweed

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746113734·DB BKT MINI TWEED NARROW LOWER ANT 018 T=0 A=0 R=0

    ACUMED

    FDA UDI
    Acumed LLC·10806378040580·AcuTwist® Trephine

    RAZOR

    FDA UDI
    Ortho Arch Company Inc·D90980021816·RAZOR PIN & LIGATURE CUTTER SLIM

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197418751·Kelly Retractor Blade 51x200...

    BIATAIN AGFOAM DRESSINGS-NON-ADHESIV: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CM

    FDA 510(k)
    FDA Unclassified ·Unknown

    Digiscan FDX

    FDA 510(k)
    FDA Class 2 ·Radiology

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·May 8, 2014

    TOTALCARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·October 8, 2012

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·August 29, 2007

    IMPL SWISSPLUS OCTAGON 4. 1MM 10MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·October 14, 2022

    VIDAS® HCG 60 TESTS

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code JHI·February 9, 2022

    Sysmex Stromatolyser-IM; a lytic reagent for use with the XE-2100, XE-2100L and XE-5000 Series Sysmex Automated Hematology Analyzers; the reagent solution is supplied in a 10-liter cubetainer (cardboard cube with a 10-liter plastic liner); Sysmex America, Inc., Mundelein, IL 60060; catalog number SIM-220A. The product is a lytic reagent used to lyse (destroy) red blood cells for hemoglobin determinations or aid in the counting of white blood cells.

    FDA Recall
    Terminated ·Sysmex America, Inc.·Product code GGK·June 23, 2009

    Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021

    ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022

    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