BEUDAMED
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    MEDISTOR III LUNG ANALYZER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MGB Alert 2X PCR Master Mix 480 rxn

    FDA UDI
    Elitechgroup Mdx LLC·03661540951725·The MGB Alert PCR Master Mix package includes r...

    ACUMED

    FDA UDI
    Acumed LLC·10806378042874·Gauging Drill Clamp Guide 2.0mm

    ORTHOPILOT NEXT GENERATION, MODEL FS101-FS106

    FDA 510(k)
    FDA Class 2 ·Neurology

    ATR TECNIKA

    FDA 510(k)
    FDA Class 1 ·Dental

    TRAVERSE DENTAL CHAIR

    FDA Adverse Event
    ENGLE DENTAL SYSTEMS·Product code EIA·May 2, 2019

    STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP

    FDA Adverse Event
    Other ·SORIN GROUP DEUTSCHLAND·Product code DWA·April 28, 2014

    UNKNOWN DEPUY ASR ACETABULAR CUP

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·October 22, 2012

    4.0MM 90-S MAX SERFAS ENERGY SUCTION PROBE

    FDA Adverse Event
    Malfunction ·STRYKER ENDOSCOPY PUERTO RICO·Product code GEI·August 3, 2010

    IVAC PRIMARY PUMP SET

    FDA Adverse Event
    Malfunction ·ALARIS MEDICAL SYSTEMS, INC.·Product code FPA·March 26, 1998

    BD PLATE CAMPYLOBACTER SB 100MM

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON DE MEXICO·Product code JSJ·June 2, 2022

    BIOMONITOR 2-AF

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code MXD·July 1, 2024

    CARDIOMESSENGER II-S TLINE

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code OSR·July 1, 2024

    Maestro Orthodontic Bracket REF711-206-10 QTY. 10 Rx Only (01)00190707016517 (10)112233 (422)484

    FDA Recall
    Terminated ·Ortho Organizers, Inc.·Product code EJF·April 2, 2019

    Maestro Orthodontic Bracket REF711-298Q QTY. 20 Rx Only (01)00190707017064 (10)889437 (422)484 Maestro Orthodontic Bracket REF711-299MCQ QTY. 20 Rx Only (01)00190707017071(10)889437 (422)484

    FDA Recall
    Terminated ·Ortho Organizers, Inc.·Product code EJF·April 2, 2019

    A-dec Decade Plus 1221 Dental Chair This chair is used for positioning dental patient prior to and during dental treatment.

    FDA Recall
    Terminated ·A-Dec Inc·Product code KLC·April 1, 2009

    Devices includes a Multi Port Inflator or without Multi Port Inflator (MPI). All the devices are vascular blood flow machines. Devices are distributed with pressure cuffs of varying sizes as accessories. Affected models include *2100-SX, 3000 series, 2017, 2016, 2015, 2014, 1059, 1059-A, *1059-C, *1058-C, 4000 series, 1100 series, 1060 series, 1080 series, 234 and 246. (* = current production model) All the devices are used in the study and diagnosis of vascular disease and blockages in the upper and lower extremities.

    FDA Recall
    Terminated ·Parks Medical Electronics, Inc·Product code DPW·August 8, 2012

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    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

    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