7 results
·
12ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Open, Classified
×
Tenaculum, Plastic
FDA Recall
Open, Classified
·Stradis Medical, LLC dba Stradis Healthcare·Product code HDC·September 10, 2021
Brand Name: Kiwi Omni Vacuum Delivery System Product Name: Kiwi Omni Vacuum Delivery System Model/Catalog Number: VAC-6000MT Product Description: The Clinical Innovations Kiwi is a disposable vacuum assisted fetal delivery system. It is a sterile, single-patient-use device designed to provide assistance in childbirth under the following conditions: 1) Term pregnancy, 2) Ruptured amniotic membranes, 3) Engaged head, 4) Complete cervical dilation, and 5) Adequately trained or supervised operator.
FDA Recall
Open, Classified
·Clinical Innovations, LLC·Product code HDB·March 9, 2026
IUD Insertion Pack
FDA Recall
Open, Classified
·Stradis Medical, LLC dba Stradis Healthcare·Product code HDC·September 10, 2021
Foundation Kit
FDA Recall
Open, Classified
·Stradis Medical, LLC dba Stradis Healthcare·Product code HDC·September 10, 2021
Standard IUD Insertion Kit
FDA Recall
Open, Classified
·Stradis Medical, LLC dba Stradis Healthcare·Product code HDC·September 10, 2021
IUD Insertion Kit
FDA Recall
Open, Classified
·Stradis Medical, LLC dba Stradis Healthcare·Product code HDC·September 10, 2021
Endometrial Biopsy Kit
FDA Recall
Open, Classified
·Stradis Medical, LLC dba Stradis Healthcare·Product code HDC·September 10, 2021