BEUDAMED
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    Jet Flow Bulk

    FDA 510(k)
    FDA Class 2 ·Dental

    10M - General Purpose

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588020143·General Purpose - 10 Metal

    Introcan Safety ® 2

    FDA UDI
    B. BRAUN MEDICAL INC.·04046955746262·Introcan Safety® 2 IV Catheter - 18 Ga. x 1.75 in.

    Symmetry Charnley

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482061169·Symmetry® Blade; Charnley Retractor; Angled; 2 ...

    Perfect Fit

    FDA UDI
    DYMEDIX DIAGNOSTICS, INC.·00817377022067·Interface Cable, FastTrack, Abdomen, Grael

    SOFIA DISTAL ACCESS CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DIGITAL BLOOD PRESSURE MONITOR, MODELS SE-9000, SE-9200 AND SE-9400

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·November 10, 2014

    OT VERIO PRO METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 23, 2013

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

    IMMULITE Calcitonin Control Module (IMMULITE, IMMULITE 1000, IMMULITE 2000, IMMULITE 2000 XPi) For in vitro diagnostic use with IMMULITE¿ Systems Analyzers  for the quantitative measurement of calcitonin (thyrocalcitonin) in human serum or heparinized plasma, as an aid in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism.

    FDA Enforcement
    Class III ·Terminated·Siemens Healthcare Diagnostics, Inc.·November 19, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·January 16, 2015

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·October 21, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·August 6, 2014

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·April 10, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·February 5, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·October 6, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 7, 2014