4 results
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7ms
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Sources: EU EUDAMED, US FDA
Stryker, REF: 0250070460, 5.0 mm x 32 cm, Strykeprobe, Outer Sheath Replacement, RX Only, Non-Sterile, CE, UDI: (01) 07613327051971 These products are distributed with the following sheath/probe: 0250070441-PKG, StrykeFlow Electrocautery Probe, Spatula Tip 5MM 0250070442-PKG, StrykeFlow Electrocautery Probe, J Tip, 5MM 0250070443-PKG, StrykeFlow Electrocautery Probe, L Tip, 5MM 0250070444-PKG, StrykeFlow Electrocautery Probe, Ball Tip, 5MM 0250070445-PKG, StrykeFlow Electrocautery Probe, Needle Tip 5MM 0250070446-PKG, StrykeFlow Electrocautery Probe, Spoon Tip, 5MM
FDA Enforcement
Class II
·Terminated·Stryker Corporation·March 25, 2020
Ultra/Phonic Focus BP Conforming Gel Pads, UDI 00300361301021 (Primary); 10300361301028 (Package) - Product Usage: A gel pad for use on woman s areola during an ultrasound examination. Its primary purpose is for patient comfort over the loose gel and helps with nipple location during the scan, making the areola location easier to identify.
FDA Enforcement
Class II
·Terminated·Pharmaceutical Innovations, Inc.·August 26, 2020
The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.
FDA Enforcement
Class II
·Terminated·Welch Allyn Protocol, Inc·January 15, 2014
Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
FDA Enforcement
Class II
·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014