| Ultra-Fast Vitri; Ultra-Fast Warm (K251305) | Kitazato Corporation | 2025-08-26 |
| Wearable Breast Pump (Model W6) (K250383) | Shenzhen TPH Technology Co., Ltd. | 2025-08-20 |
| CHLOE BLAST (K243851) | Fairtility , Ltd. | 2025-08-15 |
| Wearable Breast Pump (P9, P10, P16, P20, P21, P22, P23, P25) (K252192) | Huizhou Lvb Maternal and Infant Supplies Co., Ltd. | 2025-08-13 |
| Unscented menstrual long applicator tampon; Unscented menstrual Compact Applicator Tampon; Unscented menstrual Cardboard Applicator Tampon; Unscented menstrual Digital Tampons (K251033) | Unibeauty (Hubei) Technology Co., Ltd. | 2025-08-13 |
| eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03) (K250207) | Anker Innovations Limited | 2025-08-11 |
| Water-based Lubricant (K250142) | Global Protection Corp. | 2025-08-08 |
| Plain Water-based Lubricant (K243972) | Global Protection Corp. | 2025-08-08 |
| Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B) (K250843) | Shenzhen TPH Technology Co., Ltd. | 2025-07-31 |
| Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - Pre-curved 230 mm (REF 17500); EmbryoCath Embryo Transfer Catheter - Straight Malleable 180 mm (REF 17501); EmbryoCath Embryo Transfer Catheter - Straight Malleable 230 mm (REF 17502); EmbryoCath Stylet - 180 mm (REF 17510); EmbryoCath Stylet - 230 mm (REF 17511) (K243373) | Vitrolife Sweden AB | 2025-07-23 |
| SPY Cystoscope/Hysteroscope (K252012) | Stryker Endoscopy | 2025-07-18 |
| Thrive 2-in-1 Breast Pump (Model P3) (K250350) | Shenzhen TPH Technology Co., Ltd. | 2025-07-15 |
| Natural rubber latex male condom (K250034) | Shaoguan Regenex Pharmaceuticals Co., Ltd. | 2025-07-11 |
| Denudation Pipettes (K250838) | Guangzhou Pinzhi Medical Device Co., Ltd. | 2025-07-03 |
| Doppler FHR Detector (BF-500D+, BF-560) (K242846) | Shenzhen Bestman Instrument Co., Ltd. | 2025-06-26 |
| Prismira (K243729) | Lumos Labs, Inc. | 2025-06-13 |
| LubriZenzs (K242712) | Sk Zen, LLC | 2025-06-04 |
| RZ Resectoscope System (K243382) | Rz Medizintechnik GmbH | 2025-06-03 |
| Wearable Breast Pump (Model S21) (K250368) | Shenzhen TPH Technology Co., Ltd. | 2025-05-30 |
| Motif Aura Glow breast pump (Model Motif Aura Glow) (K250365) | Shenzhen TPH Technology Co., Ltd. | 2025-05-30 |
| FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicin (K242640) | Fertipro NV | 2025-05-30 |
| Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BEBEBAO electric breast pump (P1s) (K242725) | Ningbo Youhe Electrical Appliance Technology Co., Ltd. | 2025-05-30 |
| Koala Intrauterine Pressure Catheter (IPC-5000E) (K250897) | Clinical Innovations, LLC | 2025-05-22 |
| Harioculture TL-16 Time-lapse Incubator (K242684) | Hua Yue Medical Technology Co., Ltd. | 2025-05-22 |
| Water Solubility Human Body Lubricant (K243107) | Dongguan Yanxuan Biotechnology Co., Ltd. | 2025-05-09 |
| Sutil Rich Personal Lubricant (K250629) | Hathor Professional Skincare , Ltd. | 2025-05-02 |
| i-Cut (K243821) | A.M.I. Agency For Medical Innovations GmbH | 2025-04-25 |
| Wearable breast pump (model S12A) (K243508) | Shenzhen TPH Technology Co., Ltd. | 2025-04-21 |
| Lacevo Wearable Breast Pump (Model S70) (K250829) | Shenzhen TPH Technology Co., Ltd. | 2025-04-17 |
| LapBox Power Tissue Containment System (K250212) | Ark Surgical | 2025-04-15 |
| AirSurgN Insufflator (10030/AirSurgN) (K242772) | SmartsurgN, Inc. | 2025-04-11 |
| CooperSurgical Milex® Pessaries (K250438) | CooperSurgical, Inc. | 2025-04-11 |
| Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202) (K242089) | Jiangsu Ruifuda Medical Device Co., Ltd. | 2025-04-10 |
| Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit) (K242561) | Donnevie Medical Technology (Shanghai) Co. , Ltd. | 2025-04-10 |
| ONE Nitrile Condom (K243967) | Global Protection Corp. | 2025-04-08 |
| eufy Wearable Breast Pump S1 (T8D02) Model T8D02; eufy Wearable Breast Pump E10 (T8D03) Model T8D03; eufy Wearable Breast Pump S1 Pro (T8D04) Model T8D04; eufy Wearable Breast Pump E20 (T6060) Model T6060; (K250152) | Shenzhen TPH Technology Co., Ltd. | 2025-04-02 |
| Béa Applicator (BAP-GB-01) (K242031) | Stepone Fertility Ltd (T/A Béa Fertility) | 2025-04-02 |
| Sonata Transcervical Fibroid Ablation System 2.2 (K250705) | Gynesonics, Inc. | 2025-04-02 |
| SABA Tampons (K242105) | Essity Higiene Y Salud Mexico. S.A. DE C.V. | 2025-04-01 |
| CaseMONO™ Culture (CMON); CaseMONO™ w/HEPES (WHMO); CaseBioscience® HTF (HTFC); CaseBioscience® HTF w/HEPES (HHTF) (K242107) | Casebioscience, Inc. | 2025-03-21 |
| V-GRAD (K241833) | Vitromed GmbH | 2025-03-21 |
| Natural Cycles (K250561) | Natural Cycles Nordic AB | 2025-03-21 |
| Joylux Intimacy Gel (PG3100) (K242958) | Joylux, Inc. | 2025-03-20 |
| Ameda GLO Wearable Breast Pump (Model W8S) (K250463) | Shenzhen TPH Technology Co., Ltd. | 2025-03-20 |
| Lelo Hex Lubricated Natural Rubber Latex Condom (K243421) | Lelo, Inc. | 2025-03-07 |
| Durex Polyisoprene Condom (K241617) | Rb Health (Us), LLC | 2025-02-28 |
| Wearable breast pump (model W8) (K242850) | Shenzhen TPH Technology Co., Ltd. | 2025-02-21 |
| Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed Ecstasy) (K243640) | Church & Dwight Co., Inc. | 2025-02-21 |
| SperSort™ Sperm Sorting Chip (IPG02) (K241626) | Ipreg Incorporation | 2025-02-20 |
| 0.04 ZERO ZERO FOUR Male Latex Condom (K243584) | Okamoto USA, Inc. | 2025-02-18 |
| VIVACE (K242111) | Unimom.Co | 2025-02-06 |
| Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP) (K241454) | Guangzhou Hehong Biotech Co., Ltd. | 2025-02-03 |
| Sonicaid Team3 (K241368) | Huntleigh Healthcare , Ltd. | 2025-02-03 |
| SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL) (K241348) | Motilitycount Aps | 2025-01-31 |
| Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011); Sutil Luxe Vanilla Personal Lubricant (models 1119, 1120); Sutil Luxe Coconut Personal Lubricant (models 1121, 1122); Sutil Luxe Mint Personal Lubricant (models 1117, 1118) (K241443) | Hathor Professional Skincare , Ltd. | 2025-01-21 |
| Goldtrace Fetal Spiral Electrode (FSE) (CNS000004) (K243291) | Neoventa Medical AB | 2025-01-17 |
| High Flow Insufflation Unit (UHI-4) (K243527) | Olympus Medical Systems Corporation | 2025-01-13 |
| PeriCALM Patterns 3.0 (K241009) | Perigen, Inc. | 2025-01-10 |
| Unscented Tampon (K241064) | Shandong Intco Hygiene Products Co., Ltd. | 2025-01-10 |
| Sperm Freezing Medium (K242043) | Gimbo Medical Technology Shenzhen Co., Ltd. | 2025-01-08 |
| Momcozy Wearable Breast Pump (BP311); Momcozy Wearable Breast Pump (BP223); Momcozy Wearable Breast Pump (BP324); Momcozy Wearable Breast Pump (BP334); Momcozy Wearable Breast Pump (BP430) (K243629) | Shenzhen Root Innovation Technology Co., , Ltd. | 2024-12-20 |
| Momcozy Wearable Breast Pump (BP311) (K241680) | Shenzhen Root Innovation Technology Co., Ltd. | 2024-12-20 |
| Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010) (K241322) | Joytech Healthcare Co. , Ltd. | 2024-12-19 |
| ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100) (K241132) | Artsmedia Denmark Aps | 2024-12-18 |
| ARTSMedia Semen Wash Medium (K241095) | Artsmedia Denmark Aps | 2024-12-18 |
| Cntrl+ Bladder Support Pessary (K240798) | Cntrl+, Inc. | 2024-12-17 |
| INA Moisturizing Intimate Lubricant Water-Based Personal Lubricant (K242645) | Project Chemistry, Inc. | 2024-12-06 |
| FemVue MINI Saline-Air Device (K242002) | Femasys, Inc. | 2024-11-22 |
| Giftlife® Single-Step Medium Plus (K242968) | Gimbo Medical Technology Shenzhen Co., Ltd. | 2024-11-22 |
| VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G) (K240523) | Shenzhen Vitavitro Biotech Co., Ltd. | 2024-11-15 |
| Electric Breast Pump (F5055) (K240218) | Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. | 2024-10-17 |
| RELIEEV Uterine Manipulator Injector (CUMI 5.0) (K240364) | Li Medical Corporation , Ltd. | 2024-10-16 |
| TauTona Pneumoperitoneum Assist Device (TPAD) (K242536) | Tautona Group | 2024-10-15 |
| TROJAN SIS Synthetic Latex Condom with Silicone Lubricant (K240379) | Church & Dwight Co., Inc. | 2024-10-08 |
| Elvie Stride 2 (K242125) | Chiaro Technology, Ltd. | 2024-09-27 |
| ID Free Personal Lubricant (K240745) | Westridge Laboratories, Inc. | 2024-09-27 |
| cryo-GO Vitrification Device (K241341) | Fujifilm Irvine Scientific | 2024-09-26 |
| RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6) (K240434) | Li Medical Corporation , Ltd. | 2024-09-25 |
| Coconut Hybrid (K242162) | Good Clean Love, Inc. | 2024-09-19 |
| V-VITFREEZE and V-VITWARM (K240176) | Vitromed GmbH | 2024-09-13 |
| Wearable Breast Pump (ABP-1508PRO, ABP-1506, ABP-1306, ABP-1306 PRO, M1, M3, M8, M5, M6, K1, K2, K3, K5, ABP-1306PLUS, ABP-1308, M2) (K241004) | Huizhou Lvb Maternal and Infant Supplies Co., Ltd. | 2024-09-11 |
| FemChec Controlled Saline-Air Device (FCD-250) (K241693) | Femasys, Inc. | 2024-09-06 |
| BASEN Wearable Breast Pump (Model: YM-801, YM-803, YM-805, YM-806, YM-808) (K231969) | Dongguanshi Yiyingmei Technology Co., Ltd. | 2024-08-30 |
| Vitrification Solution Set and Warming Solution Set (K233846) | Ecmpc, LLC | 2024-08-27 |
| ONE Nitrile Condom (K240896) | Global Protection Corp. | 2024-08-23 |
| VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH) (K240307) | Shenzhen Vitavitro Biotech Co., Ltd. | 2024-08-16 |
| SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G) (K240978) | MacroLux Medical Technology Co., Ltd. | 2024-08-16 |
| Human Lubricant (K240081) | Jiangxi Wulinxiang Biological Technology Co., Ltd. | 2024-08-16 |
| Intimate Rose Vaginal Dilators (K241748) | Plus EV Holdings Dba Intimate Rose | 2024-08-14 |
| Utepreva Endometrial Sampler (UP01) (K240595) | Utepreva, LLC | 2024-08-14 |
| Ultra RapidWarm™ Blast (K240605) | Vitrolife Sweden AB | 2024-08-07 |
| Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101) (K241987) | Guangzhou Red Pine Medical Instrument Co., Ltd. | 2024-08-02 |
| Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5) (K240805) | Pelvital USA, Inc. | 2024-08-01 |
| ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US) (K240401) | Origyn Medical Technology (Hangzhou) Co., Ltd. | 2024-07-26 |
| Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) (FLT-212); Fluent Pro Fluid Management System Disposable Procedure Kit (1-pack) (FLT-212S); Fluent Pro Fluid Management System Tissue Trap Multipack (10-pack) (FLT-210); Fluent Pro Fluid Management System Waste Bag Multipack (5-pack) (FLT-205) (K240886) | Hologic, Inc. | 2024-07-25 |
| Sonata Transcervical Fibroid Ablation System 2.2 (K240503) | Gynesonics, Inc. | 2024-07-17 |
| MilkMate Breast Pump (A0006); MilkMate Kit (sterile, single-use only), 21 mm breast shield (A0005-21); MilkMate Kit (sterile, single-use only), 24 mm breast shield (A0005-24) (K241705) | Milkmate Products, Inc. | 2024-07-12 |
| Natural Cycles (K241006) | Natural Cycles Nordic AB | 2024-07-11 |
| Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341) (K233440) | Philips Medizin Systeme Boeblingen GmbH | 2024-07-02 |
| Cryo-straw (Type I, Type III); Warming Kit (A-4ML, B-8ML); Vitrification Kit (A-3ML, B-6ML) (K233477) | Shandong Wego Ruisheng Medical Device Co., Ltd. | 2024-07-01 |