11 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Vygon VY(TM)Flush Heparin Lock Flush Syringes, 100 Units per mL, 3mL in a 10mL Flush Syringe, 30 syringes per box, Rx only Prefilled syringes are used to maintain the patency of indwelling catheter lumens
FDA Enforcement
Class II
·Terminated·Vygon Corporation·June 20, 2012
Vygon VY(TM)Flush Heparin Lock Flush Syringes, 100 Units per mL, 5mL in a 10mL Flush Syringe, 30 syringes per box, Rx only Prefilled syringes are used to maintain the patency of indwelling catheter lumens
FDA Enforcement
Class II
·Terminated·Vygon Corporation·June 20, 2012
microTargeting" Drive System, Product Number 66-ZD-MD-01
FDA Enforcement
Class II
·Terminated·FHC, Inc.·July 11, 2018
Elekta Unity, Image-Guided Radiation Therapy System Product Usage: Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with a defined treatment plan. Elekta Unity is intended for use with compatible Treatment Planning and Oncology Information Systems.
FDA Enforcement
Class II
·Terminated·Elekta Limited·April 17, 2019
VitreQ 23G Silicone Tipped Cannula-CN23.D01 GTIN: 8719214221508
FDA Enforcement
Class II
·Terminated·Vitreq Bv·February 5, 2020
VitreQ 23G PFC Injection Needle- Ref: MD23.D01 GTIN: 8719214221362
FDA Enforcement
Class II
·Terminated·Vitreq Bv·February 5, 2020
VitreQ 25G Silicone Tipped Cannula-REF: CN25.D01 GTIN: 8719214221522
FDA Enforcement
Class II
·Terminated·Vitreq Bv·February 5, 2020
VitreQ 25G PFC Injection Needle-Ref: MD25.D01 GTIN: 8719214221386
FDA Enforcement
Class II
·Terminated·Vitreq Bv·February 5, 2020
Scan Monitor/ScanWatch, model number hwa09 Wearable, Bluetooth-connected wrist watch that records heart activity (ECG) and oxygen saturation (SpO2)
FDA Enforcement
Class II
·Ongoing·Withings·March 29, 2023
CryoTreQ- Aa disposable handheld instrument intended for ophthalmic surgery. It creates a tip at cryogenic temperatures by evaporation of N2O that can be utilized to perform cryotherapy based on the destruction of tissue by extreme cold to locally perform cryocoagulation on tissue. Ref: CT00.D01
FDA Enforcement
Class II
·Ongoing·Beaver Visitec International, Inc.·May 10, 2023
Nitinol TC Reusable Electrodes (TCN), Model Numbers: 1)TCN-10, 2) TCNK-10-R*, 3)TCN-10-3M, 4) TCNK-15, 5) TCN-15, 6) TCNK-15-C, 7) TCN-15-3M, 8) TCNK-15-R*, 9) TCN-20, 10) TCNK-20, 11) TCN-20-3M*, 12) TCNK-20-C*, 13) TCN-5, 14) TCNK-20-R*, 15) TCN-5-3M, 16) TCNK-5, 17) TCNK-10, 18) TCNK-5-C, 19) TCNK-10-C & 20) TCNK-5-R*. The TCN devices are indicated for use in radiofrequency (RF) heat lesioning of peripheral nerve tissue only.
FDA Enforcement
Class II
·Terminated·Cosman Medical, LLC·February 28, 2018