BEUDAMED
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    GEM(TM), FLOWCOUPLER(R), 3.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2755-FC Product Usage: The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. The FlowCOUPLER Device includes a pair of permanently implanted rings which secure the anastomosis and a removable Doppler probe that is press-fit onto one of the rings. When the FlowCOUPLER Device is used in conjunction with the FlowCOUPLER Monitor, the FlowCOUPLER System is intended to detect blood flow and confirm vessel patency intra-operatively and post-operatively at the anastomotic site.

    FDA Recall
    Terminated ·Baxter Healthcare Corp.·Product code DPW·April 21, 2016

    IMMAGE IgM Reagent Part No.: 447610

    FDA Recall
    Terminated ·Beckman Coulter Inc·Product code DEW·June 6, 2003

    07-150-07 MIZUHO, MAL DISP DOPPLER PROBE BX 4, REF 138200 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.

    FDA Recall
    Terminated ·Vascular Technology, Inc.·Product code DPW·May 28, 2014

    07-150-10 MIZUHO, DOPPLER PROBE, SLIM, BX 4, REF 138660 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.

    FDA Recall
    Terminated ·Vascular Technology, Inc.·Product code DPW·May 28, 2014

    Transonic Flow Probe, 3 mm, Catalog Number HQD3FMC -- Product Usage: to measure flow intra-operatively.

    FDA Recall
    Terminated ·Transonic Systems Inc·Product code DPW·July 27, 2015

    Dry Ash Method, Protein-Bound Iodine

    FDA classification
    FDA Class 1 ·Dry Ash Method, Protein-Bound Iodine

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    FDA Adverse Event
    Other ·DOW CORNING CORP. MDR REPORTING & COMPLAINT INVESTIGATION·Product code FTR·April 9, 1997

    DOW CORNING

    FDA Adverse Event
    Injury ·DOW CORNING CORP. MDR REPORTING & COMPLAINT INVESTIGATION·Product code FTR·December 27, 1996

    SILICONE BREAST IMPLANT

    FDA Adverse Event
    Injury ·DOW CORNING CORP./MDR REPORTING & COMPLAINT INVESTIGATION·Product code FTR·December 31, 1997

    COSMETIC AUGMENTATION

    FDA Adverse Event
    Injury ·DOW CORNING CORP./MDR REPORTING & COMPLAINT INVESTIGATION·Product code FTR·December 31, 1997

    Intranasal Electrostimulation Device For Dry Eye Symptoms

    FDA classification
    FDA Class 2 ·Intranasal Electrostimulation Device For Dry Eye Symptoms

    Intense Pulsed Light Device For Managing Dry Eye

    FDA classification
    FDA Class 2 ·Intense Pulsed Light Device For Managing Dry Eye

    Light Based Device For Dry Age-Related Macular Degeneration

    FDA classification
    FDA Class 2 ·Light Based Device For Dry Age-Related Macular Degeneration

    Inhaler, Metered Dose Or Dry Powder, Cder Or Cber Led

    FDA classification
    FDA Not Classified ·Inhaler, Metered Dose Or Dry Powder, Cder Or Cber Led

    EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal Femoral System;REPIPHYSIS™ Limb Salvage System;EVOLUTION® MP Total Knee System; EVOLUTION® MP Total Knee System; EVOLUTION® MP Adaptive CS Insert; EVOLUTION® MP Adaptive PS Tibial Insert; EVOLUTION® MP CS/CR Porous Femur/EVOLUTION® Adaptive CS and PS Inserts; EVOLUTION® Revision CCK System; ADVANCE® Double High Insert; ADVANCE® A-CLASS® Tibial Insert; ADVANCE® Knee System; ADVANCE® Ultra-Congruent Tibial Inse

    FDA 510(k)
    FDA Class 2 ·Orthopedic