| BUM Oil (K261905) | Bumlicious, LLC (DBA “Bumlicious”) | 2026-08-07 |
| DiscreetDuo™ Flow Wearable Breast Pump (Model S3) (K260259) | Shenzhen TPH Technology Co., Ltd. | 2026-07-24 |
| Natural Cycles (K253694) | Natural Cycles Nordic AB | 2026-07-17 |
| Endomat Select (UP220) (K261706) | KARL STORZ SE & CO. KG | 2026-07-16 |
| LIXI (LXOSFM1) (K253662) | Luwi, LLC | 2026-07-14 |
| Wearable Breast Pump (Model S32A) (K261199) | Shenzhen TPH Technology Co., Ltd. | 2026-07-13 |
| PINKSLIP Water-Based Personal Lubricant and Moisturizer (K261177) | PINKSLIP, LLC | 2026-07-09 |
| Plum Vagiceuticals™ Vaginal Moisturizing Suppositories (K261909) | PCCA, Inc. | 2026-07-06 |
| Claria System (DEN250034) | Claria Medical, Inc. | 2026-07-02 |
| Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3) (K250070) | Shenzhen Changkun Technology Co., Ltd. | 2026-06-26 |
| Wearable breast pump (QY-101, QY-102, QY-108) (K261025) | Shenzhen Qinyi Electronic Technology Co., Ltd. | 2026-06-25 |
| Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C) (K252584) | Weyo Surgical Technology , Ltd. | 2026-06-25 |
| Flow Water-Based Personal Lubricant (K254011) | LBDO Group, Inc. | 2026-06-22 |
| Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D) (K254254) | Shenzhen Root Innovation Technology Co., Ltd. | 2026-06-18 |
| Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D ) (K260538) | Shenzhen Root Innovation Technology Co., Ltd. | 2026-06-17 |
| Assisted Reproduction Laser System (Model ILS-400M) (K253333) | Hua Yue Medical Technology Co., Ltd. | 2026-06-17 |
| Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte Retrieval Needle (K253121) | Gimbo Medical Technology Shenzhen Co., Ltd. | 2026-06-15 |
| Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706) (K260346) | Polybell (Guangzhou) Limited | 2026-06-12 |
| AViTA Breast Pump (K250129) | Avita Corporation | 2026-06-11 |
| PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant) (K261292) | PR Personal Care Laboratories | 2026-06-11 |
| Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147) (K252914) | Hathor Professional Skincare , Ltd. | 2026-06-09 |
| Mother's Nature W1 Warming Wearable Breast Pump (K260864) | Shenzhen TPH Technology Co., Ltd. | 2026-06-09 |
| Strauss Surgical Resection Instruments (K253020) | American Medical Endoscopy, Inc. | 2026-06-04 |
| Spectra Platinum Mini (K260956) | Uzinmedicare Co., Ltd. | 2026-06-04 |
| eufy Wearable Breast Pump (T600P, T6000, T6001, T6002, T6003, T6004, T6005, T6006, T6007, T6008, T6009) (K254300) | Anker Innovations Limited | 2026-05-29 |
| pjur NATURE Touch, 100 ml (K260068) | Pjur Group Luxembourg S.A. | 2026-05-21 |
| Wearable Breast Pump (Model S39) (K254244) | Shenzhen TPH Technology Co., Ltd. | 2026-05-21 |
| Derma-2 (K253911) | Neko Health AB | 2026-05-20 |
| Manual Tissue Removal Device (K254050) | Suzhou AcuVu Medical Technology Co., Ltd. | 2026-05-15 |
| Embryo Predict (K250781) | Alife Health | 2026-05-15 |
| Jada System (Jada-2002) (K253642) | Organon, LLC | 2026-05-15 |
| Electric Breast Pump (HL-3058 II Pro) (K254125) | Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. | 2026-05-13 |
| Male Latex Condom HA (K252622) | Okamoto USA, Inc. | 2026-05-04 |
| Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434) (K253914) | Shenzhen Root Innovation Technology Co., Ltd. | 2026-04-29 |
| Ultra-Fast Warm (K260248) | Kitazato Corporation | 2026-04-28 |
| Vacuum Pump (Model: AD-VPUM-500) (K260194) | Sheng Sheng Yi (Beijing) Technology Company Limited | 2026-04-28 |
| Pelvic Floor Exerciser (PF01) (K252748) | Hunan Accurate Bio-Medical Technology Co., Ltd. | 2026-04-27 |
| Wearable Breast Pump (AOV6853, AOV6860, AOV6861, AOV6862) (K260239) | Jiangxi AOV Maternity & Baby Products Co., Ltd. | 2026-04-22 |
| Julva Velvé Water-Based Personal Lubricant (K254101) | Golden Isles Medical, Inc. | 2026-04-16 |
| Insufflator (OPTO-IFL1000) (K252318) | Guangdong Optomedic Technologies, Inc. | 2026-04-16 |
| Freestyle Mini Hands-free (K253510) | Medela, LLC | 2026-04-10 |
| Wearable Breast Pump (Model S21A) (K260033) | Shenzhen TPH Technology Co., Ltd. | 2026-04-08 |
| Momcozy Wearable Breast Pump (BP137, BP137-A, BP137-B, BP137-C, BP137-D, BP137Y-A, BP137Y-B, BP141, BP141-A, BP141-B, BP141-C, BP141-D) (K254258) | Shenzhen Root Innovation Technology Co., Ltd. | 2026-04-08 |
| Momcozy Wearable Breast Pump (S9 Pro, S9 Pro-A, S9 Pro-B, S9 Pro-C, S9 Pro-D, S9 ProY-A, S9 ProY-B, S9 ProY-C, S12 Pro, S12 Pro-A, S12 Pro-B, S12 Pro-C, S12 Pro-D, S12 ProY-A, S12 ProY-B, S12 ProY-C) (K253946) | Shenzhen Root Innovation Technology Co., Ltd. | 2026-04-07 |
| SPECTRA Wearable 2 (K250208) | Uzinmedicare Co., Ltd. | 2026-04-06 |
| Wearable Electric Breast Pump (RH 668, RH 708, RH 718, RH 728) (K252744) | Cixi Ruihong Electric Appliance Co., Ltd. | 2026-04-03 |
| Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Suppository (HA 10 mg) (K260007) | Hudi Pharma Srl | 2026-04-01 |
| Sagami Original 002 Polyurethane Male Condom (K252158) | Mayer Laboratories | 2026-03-30 |
| Asurys Fluid Management System (K251273) | Boston Scientific Corporation | 2026-03-27 |
| Livi Device (K252005) | Liviwell, Inc. | 2026-03-20 |
| Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220) (K252583) | A Cute Baby, Inc. | 2026-03-12 |
| Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380-C, M5, M5-A, M5-B, M5-C) (K253934) | Shenzhen Root Innovation Technology Co., Ltd. | 2026-03-09 |
| Water-based lubricant (K253983) | Guangzhou Haoyimai Trading Co., Ltd. | 2026-03-06 |
| JFord Speculum Sleeve™ (K252208) | Ford Medtech, LLC | 2026-03-06 |
| Mendit (K260380) | Escala Medical, Ltd. | 2026-03-04 |
| InnovexView (GC146-17, GC150-20, GC155-23) (K254251) | Shanghai AnQing Medical Instrument Co., Ltd. | 2026-02-26 |
| ANNE Maternal (K253021) | Sibel Health, Inc. | 2026-02-26 |
| Konig Bell Circumcision Clamp (K251687) | Medline Industries, LP | 2026-02-25 |
| CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5) (K252672) | Casebioscience, Inc. | 2026-02-20 |
| Motion InBra (YM-8801) wearable breast pump (K253149) | Medela, LLC | 2026-02-13 |
| Wearable Breast Pump (Model W2) (K252422) | Shenzhen TPH Technology Co., Ltd. | 2026-02-13 |
| Wearable Breast Pump (Model W12) (K252420) | Shenzhen TPH Technology Co., Ltd. | 2026-02-13 |
| Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C) (K253354) | Guangzhou Hehong Biotech Co., Ltd. | 2026-02-12 |
| Spectra S1 Pro; Spectra S2 Pro (K251423) | Uzinmedicare Co., Ltd. | 2026-02-06 |
| Pump In Style® Pro+ (K253498) | Medela, LLC | 2026-01-22 |
| Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish Pessaries with Support; Milex™ Cube Pessaries; Milex™ Cube Pessaries with Drainage Holes (K253698) | Cooper Surgical | 2026-01-20 |
| Fetal Doppler U8-25, U9-25 (K252669) | Zhongshan Xiaolan Town Senlan Electronic Factory | 2026-01-08 |
| Paruu Wearable Breast pump (P16, P16-A, P16-B, P16-C, P16-D, P20, P9, P10, P10 PRO, P21, P22, P23, P24, P25, P26, P27, P28, P29, P30, P20-A, P20-B, P20-C, P20-D) (K253072) | Linhejiacheng (Shenzhen) E-Commerce Co., Ltd. | 2025-12-23 |
| Electric Breast Pump (YM-8807, YM-8805, YM-8806, YM-8810) (K252342) | Guangdong Youmeng Electrical Technology Co., Ltd. | 2025-12-19 |
| Wearable Electric Breast Pump (YM-8803) (K252754) | Guangdong Youmeng Electrical Technology Co., Ltd. | 2025-12-19 |
| Chiavaye Personal Moisturizer (K251011) | Unipack, LLC | 2025-12-19 |
| ARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI® Single-Use Hysteroscope (SH-01A, SH-02A, SH-03A, SH-04A, SH-05A, SH-01B, SH-02B, SH-03B, SH-04B, SH-01C, SH-02C, SH-03C, SH-04C) (K252793) | Jiangsu Jiyuan Medical Technology Co., Ltd. | 2025-12-18 |
| Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital Tampons (K253719) | Unibeauty (Hubei) Technology Co., Ltd. | 2025-12-17 |
| Hybrid personal lubricant (water&silicone) (5ml, 8ml, 10ml, 12ml, 15ml, 20ml, 30ml, 50ml, 60ml, 75ml, 90ml, 100ml, 120ml, 150ml, 180ml, 200ml, 250ml, 300ml, 500ml) (K252935) | Foshan Pingchuang Medical Technology Co., Ltd. | 2025-12-15 |
| FemVue® Controlled Saline-Air Device (FSA-300) (K253403) | Femasys, Inc. | 2025-12-15 |
| Cerynë Intimate Care (K250488) | Ansella Therapeutics | 2025-12-12 |
| RELIEEV HSG Catheter (HSG7FA1) (K252260) | Li Medical Corporation , Ltd. | 2025-11-26 |
| Spectra Platinum (K251932) | Uzinmedicare Co., Ltd. | 2025-11-25 |
| LifeStyles® HydraFeel Natural Rubber Latex Condom (K252521) | Suretex Limited | 2025-11-18 |
| Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, BP432-, BP434-) (K253283) | Shenzhen Root Innovation Technology Co., Ltd. | 2025-10-29 |
| Electric Breast Pump (HL-3058, F5112) (K252629) | Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. | 2025-10-27 |
| Electric Breast Pump (HL-3060, F5113) (K252630) | Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. | 2025-10-27 |
| electric breast pump (FZ-P8); electric breast pump (YH-P8); electric breast pump (YH-P8X) (K251977) | Ningbo Youhe Electrical Appliance Technology Co., Ltd. | 2025-10-22 |
| Uterine Aspiration Set (K251882) | Gcmedica Enterprise Ltd.(Wuxi) | 2025-10-16 |
| COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS (K252939) | Cotton High Tech S.L. | 2025-10-09 |
| Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete Vacuum Delivery System, OmniCup® with Traction Force Indicator (VAC-DUAL MT); Kiwi® Complete Vacuum Delivery System, OmniC Cup® for Cesarean Section (VAC-DUAL C); Kiwi® Complete Vacuum Delivery System, ProCup® (VAC-DUAL S) (K250298) | Clinical Innovations, LLC | 2025-10-08 |
| GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device (K243152) | Applied Medical Resources Corp. | 2025-10-02 |
| Hi bebe super (BT-150B) (K251512) | Bistos Co., Ltd. | 2025-09-25 |
| ENDOFLATOR + (K250388) | Karl Storz SE & CO. KG | 2025-09-22 |
| Sonicaid Team3 (K250777) | Huntleigh Healthcare , Ltd. | 2025-09-19 |
| Unscented menstrual three-piece applicator tampon (K252613) | Unibeauty (Hubei) Technology Co., Ltd. | 2025-09-19 |
| Magic InBra (K251377) | Medela AG | 2025-09-18 |
| Fast Warm - NX (K250445) | Fujifilm Irvine Scientific | 2025-09-12 |
| Water-soluble Personal Lubricant (Satin Gel Vitamin E flavor lubricant; Satin Gel Caramel flavor lubricant; Satin Gel Peach flavor lubricant; Satin Gel Strawberry flavor lubricant.) (K251773) | Shenzhen Yongquan Medical Devices Co., Ltd. | 2025-09-09 |
| Wearable Breast Pump (Model S33) (K251754) | Shenzhen TPH Technology Co., Ltd. | 2025-09-08 |
| Momcozy Wearable Breast Pump (BP223) (K251394) | Shenzhen Root Innovation Technology Co., Ltd. | 2025-09-08 |
| Fetal Pillow (K243799) | CooperSurgical, Inc. | 2025-08-29 |
| SIRIUS Endoscope System (PR-SI-1230) (K250939) | Precision Robotics (Hong Kong) Limited | 2025-08-29 |
| Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA]) (K251637) | Donnevie Medical Technology (Shanghai) Co. , Ltd. | 2025-08-27 |
| Fetal & Maternal Monitor (F15A, F15A Air) (K241882) | Edan Instruments, Inc. | 2025-08-27 |