| 11 Jun 2025 | HSG Procedure Tray. Model Number: 6050T. The HSG Procedure Tray is for use in hysterosalpingography and sonohysterography procedures. | Device | Class II | 3 | Ongoing |
| 15 Nov 2024 | Brand Name: K-Systems Product Name: G73 Dry Bath Incubator Model/Catalog Number: K22065 Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored… | Device | Class II | 6 | Ongoing |
| 31 Jul 2024 | Silver-Plated Copper Sims Uterine Sound, Part Number 64-600 | Device | Class II | 2 | Ongoing |
| 16 Feb 2024 | Origio Sperm Wash Medium Pack of Ten 10ml bottles - Intended for washing of spermatozoa Part Number: 84051010A | Device | Class II | 3 | Ongoing |
| 20 Dec 2023 | global Medium, Model Numbers LGGG-020 (20mL bottle), LGGG-050 (50mL bottle), LGGG-100 (100mL bottle). Intended use: Culture of human embryos from zygote to blastocyst, embryo transfer. | Device | Class II | 1 | Ongoing |
| 29 Aug 2023 | Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quantity 1 Box of 3 Systems. Kit as labeled: Regard, Carter-Thomason CloseSure System, REF 733776, Contents: One (1) Carter-Thomason Suture Passer, One (1) 5 mm Pilot Guide, One (1) 10/12 mm Pilot Guide. | Device | Class II | 1 | Ongoing |
| 13 Feb 2023 | Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo culture and transfer, Reference Number H5GT-060 | Device | Class II | 1 | Ongoing |
| 15 Dec 2022 | BIOPSY MEDIUM 10ML, Reference Number 10620010 A, used for blastomere biopsy of cleavage stage embryos for Pre-implantation Genetic Diagnosis (PGD) | Device | Class II | 1 | Ongoing |
| 20 Oct 2022 | NEO-fit Neonatal Endotracheal Tube Grip, Part Number 42-2540 | Device | Class II | 1 | Ongoing |
| 12 Aug 2022 | Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark I Benchtop Incubator (AY102295). The Mark I model is no longer produced, but the legacy humidifier bottle component design can also be used with the BT37 Mark II Benchtop Incubator. | Device | Class II | 2 | Ongoing |
| 13 Jun 2022 | LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055 | Device | Class II | 1 | Ongoing |
| 1 Apr 2022 | VITRIGUARD, CARRIER, CLEAR; Model. No. 43782001 The VitriGuard device is a cryopreservation storage device composed of a stick and cap. | Device | Class II | 1 | Ongoing |
| 31 Mar 2022 | Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr -For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect uterine pathology such as polyps, fibroids, adhesions or endometrial thickening, and/or patency of fallopian tubes. Model: 61-3005 | Device | Class II | 3 | Ongoing |
| 4 Feb 2022 | PARAGARD T380A (intrauterine copper contraceptive), 1 unit per carton together with an insertion tube and solid white rod in a Tyvek polyethylene pouch, Rx Only, Manufactured by Teva Women's Health Inc. a subsidiary of Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 51285-204-01 | Drug | Class I | 1 | Terminated |
| 29 Sep 2021 | LEEP PRECISION Integrated System, 120V CooperSurgical part number: LP-10-120 | Device | Class II | 7 | Ongoing |
| 30 Jun 2021 | Oxygen Sensor Model K54019-2 used in the: G185 & G210 Incubators and G603 Work Chambers Oxygen Sensors supplied for use in the following incubator and work chamber products; G185 Standard 110V, G185 SensorTech 110V, G185 Standard 230V, G185 SensorTech 230V, G210 InviCell Standard, G210 InviCell Standard US, G210… | Device | Class II | 1 | Terminated |
| 30 Apr 2021 | CooperSurgical Wallach Loop Electrode 10mm x 10mm Square P/N: 909131. Disposable Universal Electrodes, LOOP electrodes, used for electro-excisional procedures, and for electro-fulguration procedures of the lower genital tract | Device | Class II | 1 | Terminated |
| 23 Apr 2021 | The Ultem Polymeric Resin Koh Cup is a non- sterile, reusable vaginal fornices delineator. It is made of medical grade plastics and not made with natural rubber latex. Model Number(s): KCP-30-2 | Device | Class II | 1 | Ongoing |
| 21 Jan 2021 | Milex Gellhorn Flexible under the following labels: 1) Gellhorn Flexible w/Short Stem Pessary, REF MXKPGSS2-1/4, 2-1/4" (57 mm) with Kit, 2) Gellhorn Flexible w/Short Stem Pessary, REF MXPGSS2-1/4, 2-1/4" (57 mm) without Kit, 3) Gellhorn Flexible w/Short Stem Pessary, REF MXPGSS2-3/4, 2-3/4" (70 mm) | Device | Class II | 1 | Terminated |
| 8 Sep 2020 | MediCult Vitrification Cooling Media, Model Number 12284001F | Device | Class II | 1 | Terminated |
| 3 Jun 2020 | COOPERSURGICAL Os FinderTM Cervical Dilator, Taper: 2.0 mm to 4.0 mm OD Length: 21.5 cm Box of 50 Part Number: 1176 | Device | Class II | 1 | Terminated |
| 9 Apr 2020 | CooperSurgical Dilator/Sound Set, Rx only, Sterile/EO, Made in South Korea, P/N MX21 | Device | Class II | 1 | Terminated |
| 28 Feb 2020 | Wallace Artificial Insemination Catheter, 180 mm, Sterile, Quantity: 1 Box (10 units), Model: AIC18JP, Cooper Surgical Inc., (01) 2 0888937 021749 - Product Usage: Intended use of the product is the introduction of washed spermatozoa into the uterine cavity. | Device | Class III | 1 | Terminated |
| 13 Dec 2019 | ADVANCED ENDOSEE System CANNULA, Cooper Surgical Product Code/Model Number: ESPX5 The Advanced Endosee Cannula (CooperSurgical Product Code: ESPX5) is a sterile, single-use cannula that is part of the Advanced Endosee System. The cannula contains a light source and a camera at the distal end, which can be used for… | Device | Class II | 1 | Terminated |
| 16 Oct 2019 | Quantam 2000 Electrosurgical Generator, Part number 909075. | Device | Class II | 3 | Terminated |
| 5 Sep 2019 | 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… | Device | Class III | 1 | Terminated |
| 19 Aug 2019 | LEEP Return Patient Pads (10/ box) Model # 6050Pl used in electrosurgical procedures. | Device | Class III | 1 | Terminated |
| 8 Jul 2019 | TransWarmer Warming Infant Transport Mattress, Model no. 20421 Product Usage: The TransWarmer¿ Warming Infant Transport Mattress is gel-filled, disposable mattress that provides heat for up to two hours when cold stress is a concern. The patented WarmGel heats up to 104 (when starting from 75 ) in 60 seconds or less.… | Device | Class II | 1 | Terminated |
| 18 Jun 2019 | LEEP Precision Integrated System 120V & LEEP Precision Generator, Model Nos. LP-10-120 & LP-20-120 | Device | Class II | 1 | Terminated |
| 14 Jun 2019 | Advincula Delineator with Ultem Plastic Soft Cup size 2.5 cm; Part No. AD750SC-KE25 The Advincula Delineator Uterine Manipulator is a single-use disposable device designed specifically for Total Laparoscopic Hysterectomy (TLH), Laparoscopic Assisted Vaginal Hysterectomy (LAVH), and/or Laparoscopic Supra-Cervical… | Device | Class II | 2 | Terminated |
| 23 Apr 2019 | LEEP Precision Integrated System 120V, Model LP-10-120 Product Usage: The LEEP PRECISION INTEGRATED SYSTEM l 20V combines three components - LEEP PRECISION Cart, LEEP PRECISION Generator, and the LEEP PRECISION Smoke Evacuator for loop electrosurgical excision procedures. The loop electrosurgical excision procedure… | Device | Class II | 1 | Terminated |
| 27 Mar 2019 | ICSI MICROPIPETTE CooperSurgical part number: MICC001-30-B1.0 | Device | Class II | 1 | Terminated |
| 4 Sep 2018 | Colpo-Pneumo Occluder, Part CPO-6 | Device | Class II | 1 | Terminated |
| 4 Sep 2018 | Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG) Product Usage: The Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG) are a sterile single-use medical device providing retraction to achieve and maintain optimal visualization throughout a variety of procedures. | Device | Class II | 1 | Terminated |
| 12 Mar 2018 | 5 mm Apple-Hunt Secondary Cannula/Pyramidal Tip Trocar - extended length (5 count); Model Number 900-840 Product Usage: The Apple-Hunt Secondary Cannulas are indicated for use in laparoscopic surgical procedures to provide a pathway for the introduction of endoscopic surgical instruments and allow for maintenance of… | Device | Class II | 1 | Terminated |
| 12 Mar 2018 | Fischer Cone Biopsy Excisor, Medium (5/Box); Model Number: 900-151 | Device | Class II | 1 | Terminated |
| 6 Oct 2017 | Cooper Surgical 2 MHZ Waterproof OB Probe Product The CooperSurgical 2 MHz Waterproof OB probe is for obstetrical use in the labor and department for late term obstetrical examination associated with larger women. The product detects fetal heart beats as an aid for determining fetal viability. | Device | Class II | 1 | Terminated |
| 10 Apr 2017 | CooperSurgical lnflatoball Latex Rubber Pessary sold as an individual unit and also part of the lnflatoball Pessary Kit. Product Usage: The lnflatoball Pessary is a single-patient use pessary manufactured from natural latex rubber and is used for treating cystocele and/or rectocele associated with procidentia or… | Device | Class II | 1 | Terminated |
| 25 Aug 2016 | Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Freezing Medium . Product Number: ART -8017 SAGE In Vitro Fertilization, Inc. A CooperSurgical Company 95 Corporate Drive Trumbull, CT 06611 USA | Device | Class III | 2 | Terminated |
| 16 Feb 2016 | Milex Arcing Diaphragm Size 95; Model Number: MXWS95 | Device | Class II | 1 | Terminated |
| 14 Sep 2015 | MILEX PESSARY KIT; Model Numbers: MXPES00; MXKPES00; MXKPREG03; MXKPGSK07 Product Usage: The Coopersurgical MILEX SILICONE PESSARY is used to manage a number of gynecologic issues including pelvic support defects and stress urinary incontinence. | Device | Class III | 1 | Terminated |
| 1 Sep 2015 | CooperSurgical LEEP REDIKIT-Used as a surgical preparatory kit for Loop Electrosurgical Excision Procedure P/N 6061 | Device | Class III | 1 | Terminated |
| 6 Jul 2015 | Infant Heel Warmer and Infant Gel Warmer, sold under the brand names CooperSurgical and Fisher brand as follows : CooperSurgical PN 20418 WARMGEL INFANT HEEL WARMER - PRISM BOX OF 100; PN 24401 LIQUID INFANT HEEL WARMER - PRISM BOX OF 100; and Fisher Brand. PN 24647 FISHERBRAND GEL INFANT - HEEL WARMER BOX OF 100; PN… | Device | Class II | 1 | Terminated |
| 19 Jun 2015 | Milex Vaginal-Hymenal Silicone Dilators Set of 4 P/N MX20 Product Usage: The CooperSurgical Milex Vaginal-Hymenal Silicone Dilators are used for progressive vaginal dilation therapy involving the treatment of vaginismus (muscular spasm of the vagina) and conditions that result in constriction of the vaginal and/or… | Device | Class II | 1 | Terminated |
| 20 May 2015 | MILEX OMNIFLEX DIAPHRAGM SIZE 80 Model: MXWF80 | Device | Class II | 1 | Terminated |
| 18 May 2015 | Ally Uterine Positioning System (Ally UPS) used in the mounting and positioning and holding of uterine manipulators during gynecological laproscopic procedures Model: Ally UPS | Device | Class II | 1 | Terminated |
| 13 Apr 2015 | McKesson Medi-Pak Vaginal Speculum, 10/bag Reorder No. 11-8309 Used to expose interior of the vagina to facilitate visualization during gynecological and obstetrical procedures | Device | Class II | 1 | Terminated |
| 20 Mar 2015 | Carter-Thomason II Port Closure System; Model Number(s) CTI-1015P, for use in endoscopic and laparoscopic surgery. | Device | Class II | 1 | Terminated |
| 9 Mar 2015 | WALLACH LL 100 cryosurgical units: LL100 Cryosurgical - Part Number 900001; LL110 with Pinned Yoke - Part Number 900019-70; LL100 Multi Tip W/TC - Part Number: 900629; LL100 - CO2 - Part Number 900162 | Device | Class II | 1 | Terminated |
| 9 Feb 2015 | CooperSurgical PESSARY KIT-CUBE#2, 1-3/8 in , 35 mm Part Number: MXKPEC02 | Device | Class II | 1 | Terminated |
| 26 Jan 2015 | CooperSurgical Infant Heel Gel Warmers, P/N 20418 CooperSurgical The Infant Heal Warmer, P/N 2440 To provide gentle heat to increase blood flow and enhance infant blood sample collection | Device | Class II | 4 | Terminated |
| 27 Oct 2014 | CooperSurgical LEEP RADIUS LOOP ELECTRODE (W 2.0 cm x D 1.0 cm D, 12 cm shaft ). Box of 5 Model Number(s): R2010 Intended Use: Diagnosis and treatment of non-invasive HPV-related or unrelated lesions of the lower genital tract. | Device | Class II | 1 | Terminated |
| 27 Oct 2014 | Cooper Surgical CANNULA-CURETTE 12MM; Model Number: MX562 The CooperSurgical SUCTION CANNULA-CURETTE device is used to remove tissue from within the uterine cavity on an outpatient basis. The primary uses for this device are for endometrial sampling especially of those patients with a higher risk of cancer. The… | Device | Class III | 1 | Terminated |
| 30 Sep 2014 | CooperSurgical MILEX PESSARY KITS-Ring w/Support Folding Pessary- #1 Model: MXKPRS01 Product Usage: The CooperSurgical Milex silicon pessary is a safe and effective device used to manage a number of gynecologic issues including pelvic support defects and stress urinary incontinence. This treatment option is a… | Device | Class III | 2 | Terminated |
| 3 Jul 2014 | CooperSurgical H/S CATHETER (PART # 61-5007) Intended for Hysterosonography/ Hysterosalpingography. | Device | Class II | 1 | Terminated |
| 13 May 2014 | Cooper Surgical TAMPA CATHETER 5 French 33 cm. Intended for Hysterosonography. Model Number: 61-2005 | Device | Class II | 1 | Terminated |
| 1 May 2013 | CooperSurgical TransWarmer Infant Transport Mattress with WarmGel P/N 20421 Private label: NovaPlus TransWarmer Infant Heat Therapy Mattress with WarmGel. P/N V6390 Provides warmth during transport of infant within the hospital or between hospitals | Device | Class II | 1 | Terminated |