BEUDAMED
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    PRONTO V4 EXTRACTION CATHETER 5.5F; PRONTO V4 EXTRACTION CATHETER 6F; PRONTO V4 EXTRACTION 7F; PRONTO V4 EXTRACTION CATH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Axcent Acrylics

    FDA UDI
    GARRECO, LLC·D79331034050·PREMIUM DNT BASE PURPLE FIBER HC 5 LBS

    OTHER EXTERNAL FIXATION

    FDA UDI
    Smith & Nephew, Inc.·03596010512734·CENTERING SLEEVE 5MM

    Oticon

    FDA UDI
    Oticon A/S·05707131167507·ACTO, ITC P PB DIR L BE

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·04546540348081·DRILL BIT, WL 4.6MM, DENTAL

    NIAGARA® Lateral Access System

    FDA UDI
    VB Spine LLC·10888857523753·Posterior Blade Size 50 mm

    ACCU-CHEK ® GUIDE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIABETES CARE, INC.·Product code NBW·November 18, 2022

    FORA G90 PERFORM BLOOD GLUCOSE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ENDOSCOPIC MONOPOLAR FORCEPS-SCISSORS, EMF-2000 TO 2999,ENDOSCOPICS MONOPOLARFOEPS-GRASPERS, EMF-3000 TO 3999, ENDOSCOPO

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ACCU-CHEK ® GUIDE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIABETES CARE, INC.·Product code NBW·November 21, 2022

    ROCCIA

    FDA UDI
    Silony Medical GmbH·04054896028156·ROCCIA MultiLIF Cage 10 x 34 mm, 5° Lor.

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·February 3, 2022

    EXETER V40 STEM 35.5MM

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code JDI·May 9, 2013

    ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - FREMONT·Product code DQO·May 26, 2011

    MEDTRONIK

    FDA Adverse Event
    Malfunction ·Product code LWS·August 7, 2008

    Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.

    FDA Enforcement
    Class III ·Terminated·Illumina Inc·December 31, 2014

    PULSAR and PULSAR MAX (model nos. 470, 870, 970, 972, 1170, 1171, 1172, 1270 and 1272) pacemaker. Sterilized with gaseous ethylene oxide. Guidant Corporation , Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. PULSAR and PULSAR MAX pacemakers are multiprogrammable pacemakers from Guidant. The family consists of both dual-chamber and single-chamber models, many offering adaptive-rate therapy and providing various levels of therapeutic and diagnostic functionality. Two sensors are available with the adaptive-rate models; these adapt the pacing rate to the patient's changing metabolic demand.

    FDA Recall
    Terminated ·Guidant Corporation·Product code LWP·July 18, 2005

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021

    VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021