Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Cooper CompaniesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 7 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list CooperSurgical with 85 device recalls, 42 510(k) clearances, 2 OPDP letters, 1 complete response letter, 1 drug recall and 1 drug application. The most recent is a 510(k) clearance dated Aug 19, 2026: Wallace® Aspiration Pump (WAPV1); Wallace® Pump Filter Connector (WFC); Wallace® Vacuum ….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Aug 19, 2026 | Wallace® Aspiration Pump (WAPV1); Wallace® Pump Filter Connector (WFC); Wallace® Vacuum Connection Kit (WVCK)K261083 · MQG | 510(k) clearances |
| Aug 11, 2026 | INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set. Stay-Flex tubing component. 5 units per box. Model Numbers: 44-0712,Class I · Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in u | Device recalls |
| Aug 11, 2026 | INCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set. Stay-Flex tubing component. 5 units per box. Model Numbers: 44-2707, 44-2Class I · Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in u | Device recalls |
| Aug 29, 2025 | Fetal PillowK243799 · PWB | 510(k) clearances |
| Jun 11, 2025 | Endosee System Convenience Kit with IV Tube. Model Number: ES-TRAY-IV. Endosee System Convenience Kit with IV Tube.Class II · The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, however the peel away li | Device recalls |
| Jun 11, 2025 | Endosee System Convenience Kit. Model Number: ES-TRAY. Endosee System Convenience KitClass II · The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, however the peel away li | Device recalls |
| Jun 11, 2025 | HSG Procedure Tray. Model Number: 6050T. The HSG Procedure Tray is for use in hysterosalpingography and sonohysterography procedures.Class II · The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, however the peel away li | Device recalls |
| Apr 11, 2025 | CooperSurgical Milex® PessariesK250438 · HHW | 510(k) clearances |
| Nov 15, 2024 | Brand Name: K-Systems Product Name: G85 Mini Incubator Model/Catalog Number: K22074 Software Version: N/A Product Description: An electrClass II · The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If t | Device recalls |
| Nov 15, 2024 | Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23054 Software Version: N/A Product Description: An electriClass II · The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If t | Device recalls |
| Nov 15, 2024 | Brand Name: K-Systems Product Name: Multiple/unknown Model/Catalog Number: Multiple/unknown Software Version: N/A Product Description: AClass II · The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If t | Device recalls |
| Dec 18, 2023 | Complete response letter, NDA 018680/S-074Approved | Complete response letters |
| Oct 28, 2022 | ALLY II Uterine Positioning System™ (UPS)K223064 · LKF | 510(k) clearances |
| Feb 4, 2022 | PARAGARD T380A (intrauterine copper contraceptive), 1 unit per carton together with an insertion tube and solid white rod in a Tyvek polyethClass I · Non-sterility | Drug recalls |
| Feb 12, 2021 | Warning letter: ParagardOffice of Prescription Drug Promotion | OPDP letters |
| May 21, 2020 | Advincula Delineator Uterine ManipulatorK201086 · HEW | 510(k) clearances |
| Feb 5, 2020 | Endosee SystemK200038 · HIH | 510(k) clearances |
| Jan 14, 2020 | G210 InviCell Plus with SignipHy pH monitoringK191020 · PUB | 510(k) clearances |
| Jul 25, 2019 | Untitled letter: ParaGardOffice of Prescription Drug Promotion | OPDP letters |
| Jun 12, 2019 | Wallace Dual Lumen Oocyte Recovery SystemK191291 · MQE | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
