10 results
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5ms
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Sources: EU EUDAMED, US FDA
Marrs Laparoscopic GIFT Catheters, Catalog Number:K-J-MLC-503000, Global Product Number: G18022 Product Usage: Used to place in vitro fertilized (IVF) embryos into the uterine cavity. Intended for one-time use
FDA Enforcement
Class II
·Terminated·Cook Inc.·April 4, 2018
Echosight Jansen-Anderson Intratubal Transfer Set, Catalog Number: K-J-JITS-572900, Global Product Number: G17946 Product Usage: Used to place in vitro fertilized (IVF) embryos into the uterine cavity. Intended for one-time use
FDA Enforcement
Class II
·Terminated·Cook Inc.·April 4, 2018
Norm-Ject Tuberkulin Syringe, Catalog Number: K-ATS-1000, Global Product Number: G19871 Product Usage: Used to place in vitro fertilized (IVF) embryos into the uterine cavity. Intended for one-time use
FDA Enforcement
Class II
·Terminated·Cook Inc.·April 4, 2018
Guardia Access Nano Embryo Transfer Catheter is use for transferring IVF embryos into the uterine cavity.
FDA Enforcement
Class II
·Terminated·Cook Inc.·November 27, 2019
Guardia Access Embryo Transfer Catheter is used for transferring IVF embryos into the uterine cavity.
FDA Enforcement
Class II
·Terminated·Cook Inc.·November 27, 2019
1. SMS Embryo Transfer Set, Catalog Number: K-J-SMS-571800, Global Product Number: G19182; 2. Guardia" Access Nano Embryo Transfer Catheter, Catalog Number: K-JETS-551910-L, Global Product Number: G24215; 3. Sydney IVF¿ Embryo Transfer Set, Product Number: K-JETS-7019-SIVF, Global Product Number: G18740
FDA Enforcement
Class II
·Terminated·Cook Inc.·April 4, 2018
OSTEOVATION RMX Injectable BVF 5CC . REF/UDI: 390-6001/ /00813845021082 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
FDA Enforcement
Class II
·Terminated·Osteomed, LLC·June 10, 2020
Name: Pasteur Pipets, used by the embryologist in the IVF Laboratory. Model numbers: PP-5.75-90 PP-9-90 PP-5.75-90PL PP-9-90PL
FDA Enforcement
Class II
·Terminated·ORIGIO, Inc·July 9, 2014
Medisystems 17 Gauge x 1" inch AV Fistula Needle Product Code: D9-2007MGLB Product Usage: Medisystems AVF with MasterGuard anti-stick needle protector is indicated for use as a vascular access device in hemodialysis or other extracorporeal procedures. It is intended for use in conjunction with a blood tubing set equipped with a standard medical male luer-locking connector
FDA Enforcement
Class II
·Terminated·Medisystems a NX Stage Company·January 30, 2013
BD WAVELINQ 4F EndoAVF System, Arterial Catheter 50 cm, Venous Catheter 43 cm, Sterile EO, Rx only, Mfr. Bard Peripheral Vascular, Inc., Ref W04200, Lot S0053, UDI (01)00801741182754(17)210215(10)S0053 - Product Usage: The WavelinQ 4F EndoAVF System in indicated for the creation of an arteriovenous fistula (AVF) using concomitant ulnar artery and ulnar vein or concomitant radial artery and radial vein in patients with minimum artery and vein diameters of 2.0 mm at the fistula creation site who have chronic kidney disease and need hemodialysis.
FDA Enforcement
Class II
·Terminated·Bard Peripheral Vascular Inc·April 8, 2020