BEUDAMED
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    DOUBLE-EDGE CURETTE

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    DSQ Alert® BKV ASR v3.0 Probe Mix

    FDA UDI
    Elitechgroup Mdx LLC·03661540952784·DSQ Alert® BK Virus ASR v3.0 Probe Mix contains...

    MGB Alert® BKV ASR v3.0 Probe Mix

    FDA UDI
    Elitechgroup Mdx LLC·03661540952326·MGB Alert® BK Virus ASR v3.0 Probe Mix contains...

    QUANTA LITE ASCA (S. CEREVISIAE) IGA ELISA

    FDA 510(k)
    FDA Class 2 ·Immunology

    COTTONS 100% NATURAL COTTON TAMPONS

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

    PINN MULTIHOLE W/GRIPTION 56MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·May 8, 2014

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 22, 2012

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 7, 2007

    ANTI-SIPHON PCA EXTENSION SET

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - AIBONITO·Product code FRN·February 4, 2011

    Canister HFC-134a /1000g, ALUM Product Number: 1600-00-0218 Revision .0C Coolant canister for use with surgical laser.

    FDA Recall
    Terminated ·Candela Corporation·Product code GEX·September 10, 2019

    Canister HFC-134a / 980g, ALUM Product Number: 1600-00-0223 Revision .0C Coolant canister for use with surgical laser.

    FDA Recall
    Terminated ·Candela Corporation·Product code GEX·September 10, 2019

    Canister HFC-134a /980g, ALUM, 15 pack Product Number: 1600-00-0224 Revision .0C Coolant canister for use with surgical laser.

    FDA Recall
    Terminated ·Candela Corporation·Product code GEX·September 10, 2019

    Canister HFC-134a /1000g, ALUM, 15 pack Product Number: 1600-00-0219 Revision .0C Coolant canister for use with surgical laser.

    FDA Recall
    Terminated ·Candela Corporation·Product code GEX·September 10, 2019

    Gelzone Shoulder Sleeve, Catalog Number SLV634, Lot Number 852766. Product Usage: To be used where limb support and/or elevation is considered necessary.

    FDA Recall
    Terminated ·Implantech Associates Inc·Product code HST·January 29, 2014

    Trilogy 100, 200 and 202 Ventilators The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation.

    FDA Recall
    Terminated ·Respironics, Inc.·Product code CBK·October 11, 2011

    SEDASYS Computer-Assisted Personalized Sedation System, SEDPRU01. An integrated physiological monitoring and drug delivery system intended to provide physician-led teams with a means of administering 1% propofol (10 mg/mL) injectable emulsion to sedate patients > 18 (ASA I-II) undergoing esophagogastroduodenoscopy (EGD) and colonoscopy procedures. Intended to provide physician-led teams with a means of administering 1% propofol (10 mg/mL) injectable emulsion to sedate patients > 18 (ASA I-II) undergoing esophagogastroduodenoscopy (EGD) and colonoscopy procedures.

    FDA Recall
    Terminated ·Ethicon Endo-Surgery Inc·Product code PDR·May 13, 2015