4,214 results
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14ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Medex 10 IN Pressure Injector Line w/Rot (1200psi) NS. REF B1681R, component of extravascular blood-pressure Transducer.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD Inc.·April 28, 2021
Disposable Water Trap with ''T'' for Ventilator Circuits; product reorder 6090; SIngle Patient Use only; IPI label - Manufactured by IPI Medical Products, 3217 N. Kilpatrick St., Chicago, IL 60641and Medex label - Manufactured by Medex, Carlsbad, CA 92008
FDA Recall
Terminated
·Medex Inc·Product code BYH·July 12, 2004
Disposable Water Trap with ''Y'' for Ventilator Circuits; product reorder 6091; SIngle Patient Use only; IPI label - Manufactured by IPI Medical Products, 3217 N. Kilpatrick St., Chicago, IL 60641and Medex label - Manufactured by Medex, Carlsbad, CA 92008
FDA Recall
Terminated
·Medex Inc·Product code BYH·July 12, 2004
Disposable Oxygen Mask & Bag, Adult Non-Rebreathing Mask w/Safety Vent and 84'' Tube; reorder no. 7022; SIngle Patient Only; IPI label - Manufactured by IPI Medical Products, 3217 N. Kilpatrick St., Chicago, IL 60641and Medex label - Manufactured by Medex, Carlsbad, CA 92008
FDA Recall
Terminated
·Medex Inc·Product code KGB·July 12, 2004
Ventilator Circuit with ''Y'' & elbow with 2 Water Traps, for use with/compatible with Bennett 7200; product reorder 6072WT; SIngle Patient Use only; IPI label - Manufactured by IPI Medical Products, 3217 N. Kilpatrick St., Chicago, IL 60641and Medex label - Manufactured by Medex, Carlsbad, CA 92008
FDA Recall
Terminated
·Medex Inc·Product code BZO·July 12, 2004
Disposable Oxygen Mask & Bag, a High Concentration Non-Rebreathing Mask, complete w/Bag and One Way Valves, w/84'' Tube (3 in 1 mask); reorder no. 7020; SIngle Patient Only; IPI label - Manufactured by IPI Medical Products, 3217 N. Kilpatrick St., Chicago, IL 60641and Medex label - Manufactured by Medex, Carlsbad, CA 92008
FDA Recall
Terminated
·Medex Inc·Product code KGB·July 12, 2004
CoaguChek XS PT Test; All Catalog/REF Numbers that do NOT end in 160 The CoaguChek XS PT test strips are part of the CoaguChek XS System. The CoaguChek XS System is intended for properly selected and suitably trained users or their caregivers on the prescription or other order of the treating doctor.
FDA Recall
Terminated
·TERRIFIC CARE LLC
61 Willet St
Bldg A-1, Fl 2
Passaic NJ 07055-1971·Product code GJS·December 20, 2018
Medex 3000 Series Syringe Infusion Pumps
FDA Recall
Terminated
·Medex Inc·Product code CAJ·February 16, 2004
Medex 10 IN Pressure Injector Line w/Rot (1200psi) NS. REF B1681R, component of extravascular blood-pressure Transducer.
FDA Recall
Terminated
·Smiths Medical ASD Inc.·Product code DRS·March 31, 2021
Left Heart Kit, Model Number M20268. for blood pressure monitoring.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD Inc.·April 28, 2021
LogiCal Left Heart Kit, Model Number M20553. for blood pressure monitoring.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD Inc.·April 28, 2021
Mark 910 LogiCal, Model Number DPS567201. for blood pressure monitoring and blood sampling.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD Inc.·April 28, 2021
LogiCal Monitoring Set, Model Number DPS564898. for blood pressure monitoring and blood sampling.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD Inc.·April 28, 2021
ANGIOGRAPHIC KIT W/MX123-3MR MANIFOLD, Model Number MX1030. for use during angiography and other special procedures.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD Inc.·April 28, 2021
HIGH PRESSURE TUBING, 72IN, Model Number MX152114 (Component). Stopcocks and manifolds are used to control the direction of IV fluid flow.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD Inc.·April 28, 2021
Gang Cath Lab Set, Model Number M20858R1.for the administration of IV fluids. Stopcocks and manifolds are used to control the direction of IV fluid flow.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD Inc.·April 28, 2021
Medex High Pressure Stopcock used to control the direction of IV fluid flow. This device is intended for single use only and is provided sterile and fluid path non-pyrogenic unless package is damaged or opened.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD Inc.·December 5, 2018
Tubing with male luer lock adapter (Component) a. 76 cm, REF 601280 b. 122 cm, REF 607281. component of extravascular blood-pressure Transducer.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD Inc.·April 28, 2021
HIGH PRESSURE ROTATOR (Component) a. WITH MALE LUER LOCK, Model Number MX496HP b. WITH FEMALE LUER LOCK, Model Number MX497HP. component of extravascular blood-pressure Transducer.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD Inc.·April 28, 2021
CoaguChek XS PT Test; All Catalog/REF Numbers that do NOT end in 160 The CoaguChek XS PT test strips are part of the CoaguChek XS System. The CoaguChek XS System is intended for properly selected and suitably trained users or their caregivers on the prescription or other order of the treating doctor.
FDA Enforcement
Class I
·Terminated·TERRIFIC CARE LLC·February 13, 2019