Panels › Obstetrics/Gynecology › Product code MQF · Class 2
Catheter, Assisted Reproduction
Regulation 884.6110
1510(k)s in 12 months (53 all time)
0recalls in 12 months (36 all time)
13recalls that name a 510(k)
Top companies in MQF
| Company | 510(k)s | Recalls |
|---|---|---|
| Tenderneeds Fertility LLC | 0 | 19 |
| Cook Incorporated | 7 | 5 |
| Fertility Technology Resources, Inc. | 3 | 6 |
| Smiths Medical ASD, Inc. | 0 | 6 |
| Cook Ob/Gyn | 5 | 0 |
| Cooper Surgical | 4 | 0 |
| CooperSurgical, Inc. | 3 | 0 |
| Kitazato Corporation | 3 | 0 |
| Allwin Medical Devices, Inc. | 2 | 0 |
| Fertiligent, Ltd. | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 23, 2020 | Tenderneeds Fertility LLC 2 Complete ICI Human At Home Donor Artificial Insemination Kits Tenderneeds, SKU unknown Open, Classified |
MQF | None listed |
| Dec 23, 2020 | Tenderneeds Fertility LLC Deluxe IntraCervical Insemination (ICI) Kit (3), SKU 382903096046 Open, Classified |
MQF | None listed |
| Dec 23, 2020 | Tenderneeds Fertility LLC Deluxe At-Home Human Artificial Intracervical (ICI) Insemination Kit with Pregnancy & Ovulation Tests, SKU 636391205856 Open, Classified |
MQF | None listed |
| Dec 23, 2020 | Tenderneeds Fertility LLC TenderNeeds Fertility PRO IUI Human Artificial Home Insemination Kits, SKU 133166055771 Open, Classified |
MQF | None listed |
| Dec 23, 2020 | Tenderneeds Fertility LLC 2 X Sterile Human Home Artificial Insemination Semen Kit (Human), SKU 143298592960 Open, Classified |
MQF | None listed |
| Dec 23, 2020 | Tenderneeds Fertility LLC Ultimate Fertility At Home Insemination Kit with Sperm Wash Medium, SKU ULTFKSW Open, Classified |
MQF | None listed |
| Dec 23, 2020 | Tenderneeds Fertility LLC Premium Human Artificial Intrauterine Insemination (IUI) Kit & Metal Speculum, SKU 636391205887 Open, Classified |
MQF | None listed |
| Dec 23, 2020 | Tenderneeds Fertility LLC Home Artificial Insemination Kit Human IUI ICI Pregnancy & Ovulation Tests, SKU midiuikt Open, Classified |
MQF | None listed |
| Dec 23, 2020 | Tenderneeds Fertility LLC Flex IUI Set with LED Lighted Speculum and Test kit, SKU fls1001 Open, Classified |
MQF | None listed |
| Dec 23, 2020 | Tenderneeds Fertility LLC Professional At Home Artificial Intrauterine Insemination Set (SKU 644042787811) Open, Classified |
MQF | None listed |
| Dec 23, 2020 | Tenderneeds Fertility LLC Pro Series Fertility Device (SKU 644042788139) Open, Classified |
MQF | None listed |
| Dec 23, 2020 | Tenderneeds Fertility LLC Professional Clinical Artificial Intrauterine Insemination Kit (SKU 636391205962, 636391206013) Open, Classified |
MQF | None listed |
| Dec 23, 2020 | Tenderneeds Fertility LLC Professional Artificial Intrauterine Insemination Kit (SKU 636391205986) Open, Classified |
MQF | None listed |
| Dec 23, 2020 | Tenderneeds Fertility LLC Premium At Home Pro Series Insemination Kit (SKU 644042787927) Open, Classified |
MQF | None listed |
| Dec 23, 2020 | Tenderneeds Fertility LLC Deluxe At Home Artificial Insemination Kit (SKU 636391205832) Open, Classified |
MQF | None listed |
| Dec 23, 2020 | Tenderneeds Fertility LLC Deluxe At Home Pro Series Insemination Kit (SKU 644042787958) Open, Classified |
MQF | None listed |
| Dec 23, 2020 | Tenderneeds Fertility LLC At Home Artificial Intrauterine Insemination Flex Set (SKU 636391205870) Open, Classified |
MQF | None listed |
| Dec 23, 2020 | Tenderneeds Fertility LLC At Home Semi-Flex/Rigid Insemination Device (SKU 644042787903) Open, Classified |
MQF | None listed |
| Dec 23, 2020 | Tenderneeds Fertility LLC At Home Artificial Intrauterine Insemination Kit (SKU 636391205825, 636391205894, 636391205900, 636391205924, 636391205863, 636391205931, 636391205849, 636391206020, 644042787583, 636391205917, and 63 Open, Classified |
MQF | None listed |
| Oct 3, 2019 | Cook Inc. Guardia Access Embryo Transfer Catheter is used for transferring IVF embryos into the uterine cavity. Terminated |
MQF | K983594 |
| Oct 3, 2019 | Cook Inc. Guardia Access Nano Embryo Transfer Catheter is use for transferring IVF embryos into the uterine cavity. Terminated |
MQF | K983594 |
| Dec 19, 2017 | Cook Inc. 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: G24 Terminated |
MQF | K983594 |
| Dec 19, 2017 | Cook Inc. 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 o Terminated |
MQF | K983590 |
| Dec 19, 2017 | Cook Inc. 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 cavi Terminated |
MQF | K983591 |
| May 3, 2013 | Smiths Medical ASD, Inc. Wallace Sure-Pro Single Stage Embryo Replacement Catheter
Product Code: PP623
Sure-Pro Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following in vitr Terminated |
MQF | K033084 K990349 +1 |
| May 3, 2013 | Smiths Medical ASD, Inc. Wallace Sure-Pro Two Stage Embryo Replacement Catheter for difficult transfer with Stylet
PPS623
Sure-Pro Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity Terminated |
MQF | K033084 K990349 +1 |
| May 3, 2013 | Smiths Medical ASD, Inc. Wallace Sure-Pro Two Stage Embryo Replacement Catheter with Obturator
PPB623
Sure-Pro Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following in vitro Terminated |
MQF | K033084 K990349 +1 |
| May 3, 2013 | Smiths Medical ASD, Inc. Wallace Sure-Pro Ultra Embryo Replacement Catheter with Stylet
Product Code:PES623
Sure-Pro Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following in Terminated |
MQF | K033084 K990349 +1 |
| May 3, 2013 | Smiths Medical ASD, Inc. Wallace Sure-Pro Ultra Embryo Replacement Catheter with Obturator
Product Code: PEB623
Sure-Pro Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following Terminated |
MQF | K033084 K990349 +1 |
| May 3, 2013 | Smiths Medical ASD, Inc. Wallace Sure-Pro/ Sure-Pro Ultra Embryo Replacement Catheters (with ultrasound)
Product Code: PE623
Sure-Pro Embryo Replacement Catheters are used for the introduction of embryos into the uterine ca Terminated |
MQF | K033084 K990349 +1 |
| Jan 19, 2008 | Fertility Technology Resources, Inc. Morton IUI Catheter, Sterile, Single Use Only, Order #: ftr510, Manufactured by Fertility Technology Resources, Inc., Marietta, GA 30062 Terminated |
MQF | None listed |
| Jan 19, 2008 | Fertility Technology Resources, Inc. Tucker Embryo Catheter for Trial Transfer, 20 cm, Order #: ftr320, Manufactured by: Fertility Technology Resources, Inc., Marietta, GA 30062 Terminated |
MQF | None listed |
| Jan 19, 2008 | Fertility Technology Resources, Inc. Tucker Embryo Catheter with URM Tip, Embryo Transfer Catheter, 23 cm, Order #: ftr123, Manufactured by: Fertility Technology Resources, Inc., Marietta, GA 30062 Terminated |
MQF | None listed |
| Jan 19, 2008 | Fertility Technology Resources, Inc. Tucker Embryo Catheter with URM Tip, Embryo Transfer Catheter, 20 cm, Order #: ftr120, Manufactured by: Fertility Technology Resources, Inc., Marietta, GA 30062 Terminated |
MQF | None listed |
| Jan 19, 2008 | Fertility Technology Resources, Inc. Tucker Embryo Catheter, Stylet, For use with Embryo Transfer Catheter, 20 cm, Sterile, Single Use Only, Order #: ftr 220, Manufactured by Fertility Technology Resources, Inc., Marietta, GA 30062 Terminated |
MQF | K041470 |
| Jan 19, 2008 | Fertility Technology Resources, Inc. Tucker Embryo Catheter, Stylet, For use with Embryo Transfer Catheter, 23 CM, Sterile, Single Use Only, Order #: ft r 223, Manufactured by Fertility Technology Resources, Inc., Marietta, GA 30062 Terminated |
MQF | K023017 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.