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    POGO Automatic Blood Glucose Monitoring System

    FDA UDI
    INTUITY MEDICAL, INC.·00856176008001·Blood Glucose Meter

    POGO Automatic Test Cartridges

    FDA UDI
    INTUITY MEDICAL, INC.·00856176008056·Blood glucose test cartridges with 10 tests per...

    POGO Automatic Control Solution

    FDA UDI
    INTUITY MEDICAL, INC.·00856176008025·Level 1 Control Solution (75 mg/dL)

    POGO Automatic Control Solution

    FDA UDI
    INTUITY MEDICAL, INC.·00856176008032·Level 2 Control Solution (150 mg/dL)

    POGO AUTOMATIC BLOOD GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Injury ·INTUITY MEDICAL, INC.·Product code NBW·April 8, 2021

    POGO AUTOMATIC METER

    FDA Adverse Event
    Injury ·INTUITY MEDICAL, INC·Product code NBW·July 27, 2022

    POGO AUTOMATIC METER

    FDA Adverse Event
    Injury ·INTUITY MEDICAL, INC.·Product code NBW·March 30, 2021

    DA VINCI SI SURGICAL SYSTEM

    FDA Adverse Event
    Death ·INTUITIVE SURGICAL,INC.·Product code NAY·April 25, 2014

    Intuitive Surgical Inc. Large Clip Applier instruments used in conjunction with da Vinci S and da Vinci SI Surgical Systems Intuitive Surgical Inc., 'Sunnyvale, CA 94086

    FDA Recall
    Terminated ·Intuitive Surgical, Inc.·Product code NAY·June 13, 2014

    da Vinci S. Surgical System, da Vinci Si and da Vinci Si-e Surgical Systems. Intuitive Surgical, Inc. Sunnyvale, CA 94086. The Intuitive Surgical Endoscopic instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.

    FDA Recall
    Terminated ·Intuitive Surgical, Inc.·Product code NAY·February 6, 2012

    da Vinci Xi EndoWrist Stapler 45 Reload Green, Model 48445G-03, 12 reloads/box.

    FDA Recall
    Terminated ·Intuitive Surgical, Inc.·Product code GDW·April 23, 2018

    da Vinci Xi EndoWrist Stapler 45 Reload Blue, Model 48645B-03, 12 reloads/box.

    FDA Recall
    Terminated ·Intuitive Surgical, Inc.·Product code GDW·April 23, 2018

    Patient Side Cart assembly, 4-arm, for use with Intuitive Surgical, Inc. da Vinci Surgical System IS 4000. The patient-side cart is positioned at the operating room table and contains four arms that are positioned over the target patient anatomy. The endoscope attaches onto any arm. The patient-side assistant attaches/detaches the endoscope and instrument intra-operatively.

    FDA Recall
    Terminated ·Intuitive Surgical, Inc.·Product code NAY·May 9, 2014

    Oertli 1. 23G Laser Probe OS4 Flex-Tip VK401113 2. 23G Laser Probe OS4 Illuminated Flex-Tip VK401213 3. 23G Laser Probe OS4 Intuitive Exendable VK401323 4. 25G Laser Probe OS4 Flex-Tip VK401115 5. 25G Laser Probe OS4 Illuminated Flex-Tip VK401215 6. 25G Laser Probe OS4 Intuitive Exendable VK401325 7. 27G Laser Probe OS4 Intuitive Exendable VK401327

    FDA Recall
    Open, Classified ·Vortex Surgical Inc.·Product code HQB·December 16, 2025

    Assembly, Patient Side Manipulator on da Vinci Surgical Systems: da Vinci S Surgical System; da Vinci SI Surgical System da Vinci Si-e Surgical System; Manufactured by Intuitive Surgical Sunnyvale, CA 94086. The Intuitive Surgical Endoscopic Instrument Control System (Intuitive Surgical da Vinci Surgical System Model IS2000/3000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electro cautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electro cautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general cardiovascular and non-cardiovascular thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system is indicated for adult and pediatric use

    FDA Recall
    Terminated ·Intuitive Surgical, Inc.·Product code NAY·November 11, 2013

    da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1098,Box)

    FDA Recall
    Open, Classified ·Intuitive Surgical, Inc.·Product code NAY·December 15, 2025

    IS4000 da Vinci Xi - Endoscope accessory; 0 Degree, 8mm Endoscope. Intuitive Surgical Inc.

    FDA Recall
    Terminated ·Intuitive Surgical, Inc.·Product code NAY·June 11, 2014

    IS4000 da Vinci Xi - Endoscope accessory; 30 Degree, 8mm Endoscope. Intuitive Surgical Inc.

    FDA Recall
    Terminated ·Intuitive Surgical, Inc.·Product code NAY·June 11, 2014

    Single Site Bipolar Maryland Forceps Intuitive Surgical, Sunnyvale, CA. 94086 The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation, electrocautery and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo-oophorectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, scissors, suction irrigators, monopolar cautery, bipolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the 5mm Single-Site Port. 2.

    FDA Recall
    Terminated ·Intuitive Surgical, Inc.·Product code NAY·October 2, 2013

    Single Site Curved Needed Driver Intuitive Surgical, Sunnyvale, CA. 94086 The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation, electrocautery and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo-oophorectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, scissors, suction irrigators, monopolar cautery, bipolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the 5mm Single-Site Port.

    FDA Recall
    Terminated ·Intuitive Surgical, Inc.·Product code NAY·October 2, 2013