1,422 results
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17ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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Embryology Heated Plate within the RI Witness, Model Numbers 6-70-807, 6-70-807-A, & 6-70-807-B - Product Usage: RI Witness uses Radio Frequency Identification (RFID) to detect and monitor all activity in the IVF laboratory. The system helps mitigate the risk of human error every time samples are moved from one dish or tube to another, and safeguards every step of the IVF cycle. While the heated plates comprise a heated composite surface with window for a light source. The heated plates comprise a heated composite surface with window for a light source and either sit on top of existing bench-tops or can be integrated to be flush fitted within workstations. Intended use: Provide a favorable temperature environment for the embryo during the IVF procedure.
FDA Recall
Terminated
·CooperSurgical, Inc.·Product code MQG·September 5, 2019
NIPRO SafeTouch II Safety AVF Needle, 17G x 1 inch. Item code FS+173230BC.
FDA Recall
Terminated
·Nipro Medical Corporation·Product code FOZ·April 1, 2014
Guardia Access Embryo Transfer Catheter is used for transferring IVF embryos into the uterine cavity.
FDA Recall
Terminated
·Cook Inc.·Product code MQF·October 3, 2019
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 Recall
Terminated
·Cook Inc.·Product code MQF·December 19, 2017
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 Recall
Terminated
·Cook Inc.·Product code MQF·December 19, 2017
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 Recall
Terminated
·Cook Inc.·Product code KYZ·December 19, 2017
Guardia Access Nano Embryo Transfer Catheter is use for transferring IVF embryos into the uterine cavity.
FDA Recall
Terminated
·Cook Inc.·Product code MQF·October 3, 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 Recall
Terminated
·Cook Inc.·Product code MQF·December 19, 2017
Sydney IVF Culture Oil, REF, K- SICO- 50, 50 mL. and K-SICO-200, 200 mL,Store at 2-8 C, Sterile, Cook Medical, William A Cook Australia LTD, Product Usage: Culture oil is intended to be used as an oil overlay for cultures of gametes, zygotes, or embryos in assisted reproductive technology (ART) and micro manipulation procedures. It is used to reduce the osmotic stress due to evaporation and to reduce pH fluctuations.
FDA Recall
Terminated
·Cook, Inc.·Product code MQL·February 15, 2012
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 Recall
Terminated
·ORIGIO, Inc·Product code MQK·June 20, 2014
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 Recall
Terminated
·Osteomed, LLC·Product code MQV·April 2, 2020
IVF Pasteur Pipettes, glass, cotton plugged, length 9", in boxes of 90 consisting of 30 nylon tube packages of 3 pipettes each. Item # PP-9-90PL. Boxes are labeled in part ***Humagen Fertility Diagnostics, Inc. 2400 Hunter's Way Charlottesville, VA 22911***
FDA Recall
Terminated
·Humagen Fertility Diagnostics, Inc.·Product code MQK·May 8, 2007
Medisystems (a Nxstage Company) Hemodialysis Fistula Needle Set with MasterGuard Ant-Stick Needle Protector 15 GA x 1" Ref. Number: D9-2007MG. 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 Recall
Terminated
·Medisystems Corp·Product code FIE·January 31, 2012
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 Recall
Terminated
·Medisystems a NX Stage Company·Product code FIE·December 20, 2012
Advisor Vital Signs Monitor (model 9200), catalog number 925454225, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002B1) CE/MDD marking, 3-lead 50 Hz ECG, Standard SPO2 option and battery.
FDA Recall
Terminated
·Smiths Medical PM, Inc.·Product code DPS·September 1, 2005
Advisor Vital Signs Monitor (model 9200), catalog number 925474335, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002B1) CE/MDD marking, 3-lead 50 Hz ECG, standard SPO2 option, Invasive Pressure/Temperature option, printer and battery.
FDA Recall
Terminated
·Smiths Medical PM, Inc.·Product code DPS·September 1, 2005
Advisor Vital Signs Monitor (model 9200), catalog number 925754225, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002B1) CE/MDD marking, 5-lead 60 Hz ECG, standard SPO2 and battery.
FDA Recall
Terminated
·Smiths Medical PM, Inc.·Product code DPS·September 1, 2005
Advisor Vital Signs Monitor (model 9200), catalog number 92D754335, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002B1) 5-lead 60 Hz ECG, standard SPO2 option, invasive Pressure/Temperature, printer and battery.
FDA Recall
Terminated
·Smiths Medical PM, Inc.·Product code DPS·September 1, 2005
Advisor Vital Signs Monitor (model 9200), Catalog number 920654235, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002B1) with 3-lead 60 Hz ECG, standard SPO2 option, printer and battery.
FDA Recall
Terminated
·Smiths Medical PM, Inc.·Product code DPS·September 1, 2005
Advisor Vital Signs Monitor (model 9200), catalog number 920754235, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002B1) 5-lead 60 Hz ECG, standard SPO2 option, printer and battery.
FDA Recall
Terminated
·Smiths Medical PM, Inc.·Product code DPS·September 1, 2005