BEUDAMED
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    Infrared Thermometer

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Lockheed - 18 Metal

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588015026·Lockheed - 18 Metal

    K2 OPAQUER powder, O-B3, 15g.

    FDA UDI
    Yeti Dentalprodukte GmbH·EYET3201508·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450196748·

    16PW - Loggers - Poly White

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588015040·16PW - Loggers - Poly White

    Arena-C®

    FDA UDI
    SPINEFRONTIER, INC.·00190361036609·Trial Spacer, Assembly, Straight, 8mm

    EQUINOXE PRESERVE STEM 6MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·July 27, 2023

    OPUSDUO EC DENTAL LASER SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    LASERSKIN DRESSING

    FDA 510(k)
    FDA Unclassified ·Unknown

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·March 9, 2011

    SOLETRA

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·October 17, 2008

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·August 11, 2011

    ANEURX

    FDA Adverse Event
    Injury ·MEDTRONIC CARDIOVASCULAR SANTA ROSA·Product code MIH·July 2, 2013

    SMR CEMENTLESS FINNED STEM

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code HSD·April 8, 2022

    HardyCHROM MRSA Cat no: G307 Lot no: H15155 Expires: 2015-08-13 Container Type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage: 2-8C on receipt. Light Sensitive. In vitro diagnostic www.HardyDiagnostics.com

    FDA Recall
    Terminated ·Hardy Diagnostics·Product code JSO·July 9, 2015

    HardyCHROM MRSA Cat no: G307 Lot no: H15155 Expires: 2015-08-13 Container Type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage: 2-8C on receipt. Light Sensitive. In vitro diagnostic www.HardyDiagnostics.com

    FDA Enforcement
    Class II ·Terminated·Hardy Diagnostics·September 2, 2015

    Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

    American Surgical Delicot 30mm x 70mm Ref: 63-10 Product Usage: Neurosurgical and Nonneurosurgical Sponges

    FDA Enforcement
    Class II ·Terminated·American Surgical Company·June 1, 2016

    Rapid Neg Urine Combo Panel Type 1; Catalog number B 1017-167; Siemens Material Number 10444652 MicroScan Rapid panels are designed for use in determining identification to the species level and/or antimicrobial agent susceptibility of rapidly growing aerobic and facultatively anaerobic gram negative bacilli.

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

    American Surgical Ultracot 20 mm x 60 mm Ref Number: 23-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges

    FDA Enforcement
    Class II ·Terminated·American Surgical Company·June 1, 2016