| EVA (Enhanced Visual Assessment) System (K161871) | Mobileodt , Ltd. | 2016-12-19 |
| Cryotec (K162051) | Reprolife, Inc. | 2016-12-14 |
| U-Blade Veress Needle (K162648) | Tianjin Uwell Medical Device Manufacturing Co., Ltd. | 2016-12-12 |
| Proture Double Electric Breast Pump (K162747) | Guangdong Horigen Mother & Baby Products Co., Ltd. | 2016-12-08 |
| Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal Device (K161763) | Smith & Nephew, Inc. | 2016-11-22 |
| Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail, Connector spare parts kit, Silicone Membrane, retail, Power Adaptor, retail (K161725) | Medela, Inc. | 2016-10-28 |
| ColpoWave™ Colpotomizer and CerviGrip™ Uterine Manipulator (K161065) | Surgitools Pty , Ltd. | 2016-10-27 |
| aoni Natural Rubber Latex Condom (K153016) | Guangzhou Daming United Rubber Products , Ltd. | 2016-10-20 |
| Cryotop Vitrification Kit and Cryotop Thawing Kit (K160864) | Kitazato Biopharma Co., Ltd. | 2016-10-07 |
| uVue HSG/SHG Catheter (K160217) | Cook Incorporated | 2016-10-06 |
| Colposcope System (K160341) | Xuzhou Kernel Medical Equipment Co., Ltd. | 2016-09-14 |
| Trojan XOXO Ribbed Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant (K161915) | Church & Dwight Co., Inc. | 2016-09-09 |
| Central Monitoring System (K153580) | Guangdong Biolight Meditech Co., Ltd. | 2016-09-07 |
| Mano and Mano Personal Lubricant (K161585) | Mano and Mano Proprietary Limited | 2016-09-06 |
| Hi bebe plus (K160274) | Bistos Co., Ltd. | 2016-09-01 |
| Trojan Chain Reaction Personal Lubricant (K161544) | Church & Dwight Co., Inc. | 2016-08-31 |
| Philips Avent Comfort Single/Twin Electric Breast Pump (K161532) | Philips Consumer Lifestyle - Innovation Site Eindhoven | 2016-08-29 |
| Trojan XOXO Thin Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant (K161545) | Church & Dwight Co., Inc. | 2016-08-26 |
| Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors) (K161195) | M3 Global Enterprises, LLC | 2016-08-25 |
| Just Like Me Personal Lubricant (K161385) | Wtfn-Dba Classic Erotica/Holiday Products | 2016-08-17 |
| Sydney IVF Gamete Buffer (K153478) | William A. Cook Australia Pty. , Ltd. | 2016-08-15 |
| Athena Breast Pump (K161266) | Exploramed Nc7, Inc. | 2016-08-11 |
| Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, RegularOpal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Super, Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Super Pl (K161877) | First Quality Hygienic, Inc. | 2016-08-05 |
| Aqueduct 100 Cervical Dilator (K160664) | Gtimd, LLC | 2016-08-01 |
| PBS(-), Phosphate Buffered Saline (K160863) | Kitazato Biopharma Co., Ltd. | 2016-07-28 |
| Skyn Original Polyisoprene Lubricated Male Condom (K160399) | Ansell Healthcare Products, LLC | 2016-07-25 |
| ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash (K153267) | Origio A/S | 2016-07-22 |
| RI Witness Embryology Heated Plate (K160504) | Research Instruments Limited | 2016-07-18 |
| Panpac Disposable Pessary Fitting Set (K153422) | Panpac Medical Corporation | 2016-07-14 |
| Pulse H20h! (K152628) | Toaster Labs, Inc. | 2016-07-11 |
| Pulse Aloe-ahh (K152671) | Toaster Labs, Inc. | 2016-07-11 |
| PeriCoach OTC (K160758) | Analytica, Ltd. | 2016-07-11 |
| NeuGuide (K160569) | Pop Medical Solutions | 2016-07-06 |
| Lelo Hex Natural Rubber Latex Condom (K160644) | Lelo, Inc. | 2016-06-30 |
| Repagyn vaginal suppositories (K153372) | Farma-Derma S.R.L. | 2016-06-30 |
| ally Liquid Personal Lubricant (K160763) | Private Label Production, LLC | 2016-06-29 |
| Regular and Special Umbilical Cord Clamp and Cutter (K152350) | Ningbo Feite Medical Device Co., Ltd. | 2016-06-28 |
| Liger Medical HTU-110 (K152843) | Liger Medical, LLC | 2016-06-24 |
| Naya Breast Pump System (K160511) | Naya Health, Inc. | 2016-06-24 |
| S698 Symbioz flow (K153367) | Sopro - Acteon Group | 2016-06-17 |
| ROMA Calculation Tool Using Elecsys Assays (K153607) | Roche Diagnostics | 2016-06-15 |
| Symphion Endoscope and Symphion Cervical Sheath (K160751) | Boston Scientific | 2016-06-14 |
| ally Warming Liquid Personal Lubricant (K160717) | Private Label Production, LLC | 2016-06-14 |
| MAKO 7 (K160510) | Nvision Medical Corporation | 2016-06-09 |
| Gun Oil, Pink, Gun Oil H2O, Pink Water (K152918) | Empowered Products, Inc. | 2016-06-02 |
| FirstSense Breast Exam (K160573) | First Sense Medical, LLC | 2016-06-01 |
| Dr. Wolff Vagisan Moisturising Cream (K152507) | Dr. August Wolff GmbH & Co. KG Arzeimittel | 2016-05-20 |
| Lumipulse G ROMA (K160090) | Fujirebio Diagnostics,Inc. | 2016-05-16 |
| LT-300 HD (K160380) | Lutech Industries, Inc. | 2016-05-13 |
| Sydney IVF Blastocyst Cryopreservation Kit, Sydney IVF Blastocyst Thawing Kit (K152717) | William A. Cook Australia Pty. , Ltd. | 2016-05-06 |
| Sydney IVF Cryopreservation Kit, Sydney IVF Thawing Kit (K152682) | Willian A. Cook Australia Pty, Ltd. | 2016-05-05 |
| Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze Kit, Vit Kit-Thaw Oocytes, Embryos and PN zygotes Vitrification Thaw Kit (K160006) | Irvine Scientific | 2016-05-04 |
| ARCHITECT ROMA (K151502) | Fujirebio Diagnostics,Inc. | 2016-04-28 |
| Wet Original Personal Lubricant (K160211) | Trigg Laboratories D/B/A Wet International | 2016-04-27 |
| MIRI TL (K151357) | At Medical Uab | 2016-04-22 |
| Sydney IVF Sperm Cryopreservation Buffer (K160814) | William A. Cook Australia Pty. , Ltd. | 2016-04-22 |
| MINERAL OIL (K160142) | Kitazato Biopharma Co., Ltd. | 2016-04-21 |
| Spectra S1Plus and Spectra S2 Plus (K150476) | Uzinmedicare Co. | 2016-04-15 |
| LifeGlobal Micro Tips (K152581) | Life Global Group, LLC | 2016-04-11 |
| PneumoLiner (DEN150028) | Advanced Surgical Concepts, Ltd. | 2016-04-07 |
| OVA1 Next Generation (K150588) | Vermillion, Inc. | 2016-03-18 |
| Cryotop US (K153027) | Kitazato Biopharma Co., Ltd. | 2016-03-14 |
| SYLK PERSONAL LUBRICANT (K152646) | Toro Management, LLC Dba Sylk | 2016-03-11 |
| Insufflator 50L FM134 (K153513) | W.O.M. World of Medicine GmbH | 2016-03-04 |
| BlastGen (K152932) | Origio A/S | 2016-02-29 |
| Love Liquid Personal Lubricant (K152168) | The Kama Sutra Company | 2016-02-05 |
| SD5 & SD6 Ultrasonic Tabletop Doppler (K153475) | Edan Instruments, Inc. | 2016-01-29 |
| Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium, Sydney IVF Blastocyst Medium (K153290) | William A. Cook Australia Pty. , Ltd. | 2016-01-27 |
| Sydney IVF Hyaluronidase (K151367) | William A. Cook Australia Pty. , Ltd. | 2016-01-27 |
| ebb Complete Tamponade System (K153591) | Clinical Innovations, LLC | 2016-01-14 |
| K-Y Marilyn Pleasure Gel (K151884) | Reckitt Benckiser, LLC | 2016-01-11 |
| Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette (K151018) | Cook Incorporated | 2016-01-08 |
| Luvena Enhanced Personal Moisturizer, Luvena Enhanced Personal Lubricant (K150841) | Laclede, Inc. | 2015-12-29 |
| ENDOPLUS hand-held laparoscopic instruments (K151567) | Endoplus | 2015-12-23 |
| SYDNEY IVF SPERM MEDIUM, SYDNEY IVF SPERM GRADIENT KIT, SYDNEY IVF SPERMIENT (K152782) | William A. Cook Australia Pty. , Ltd. | 2015-12-21 |
| Ally Uterine Positioning System (K153092) | CooperSurgical, Inc. | 2015-12-21 |
| FreezeKit Cleave , ThawKit Cleave (K150950) | Vitrolife Sweden AB | 2015-12-21 |
| Electric Double Breast Pumps (K151284) | Wuxi Xinzhongrui Baby Supplies Co., Ltd. | 2015-12-21 |
| Flexipet Denuding Pipette, Flexipet Manipulation Pipette (K150748) | Cook Incorporated | 2015-12-18 |
| O-RING Condom (K150828) | O-Ring Products, LLC | 2015-12-18 |
| Always/Tampax bladder supports (K151413) | Procter & Gamble | 2015-12-18 |
| EmbryoSlide Culture Dish (K150961) | Vitrolife A/S | 2015-12-04 |
| COHITECH NON APPLICATOR ORGANIC COTTON TAMPONS;COHITECH COMPACT APPLICATOR ORGANIC COTTON TAMPONS (K152284) | Cotton High Tech S.L. | 2015-12-04 |
| SYDNEY IVF EMBRYO BIOPSY MEDIUM (K152904) | William A. Cook Australia Pty. , Ltd. | 2015-12-03 |
| Video Colposcope (K151878) | Edan Instruments, Inc. | 2015-12-01 |
| MedGyn Straight IUI Catheter, MedGyn Mini IUI Catheter, MedGyn curved, mini IUI Catheter (K143669) | Medgyn Products, Inc. | 2015-11-23 |
| SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 Link (K150525) | KARL STORZ Endoscopy-America, Inc. | 2015-11-20 |
| Good Clean Love Personal Lubricants Almost Naked and Natural Cinnamon Vanilla (K150094) | Good Clean Love, Inc. | 2015-11-19 |
| MAKO Device (K151275) | Nvision Medical | 2015-11-13 |
| Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices (K152723) | Hologic, Inc. | 2015-11-13 |
| Water Based Personal Lubricant with Flavours (K150743) | Karex Industries Sdn. Bhd. | 2015-11-12 |
| Divine 9 (K150397) | Carrashield Labs, Inc. | 2015-11-09 |
| Breast Pump (K150923) | Guangzhou Jinxinbao Electronic Co., Ltd. | 2015-11-06 |
| Symphony Breastpump, Symphony reconditioned, Symphony Preemie+ Breastpump, Symphony Plus Breastpump (battery version), Symphony Consignment, Preemie Consignment Pump, Symphony Rental, Symphony Plus Rental, Symphony Preemie+ Rental (K151632) | Medela AG | 2015-11-05 |
| Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Light Absorbency; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Regular & Super; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Super Plus; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Super Absorbency (K151470) | First Quality Hygienic, Inc. | 2015-11-02 |
| INVOcell (DEN150008) | Invo Bioscience | 2015-11-02 |
| Swiss Navy Premium Silicone Lubricant;Swiss Navy Premium Water Based Lubricant;Swiss Navy Premium All Natural Lubricant (K150153) | Package Solutions, LLC | 2015-10-20 |
| GelPOINT Transvaginal Access Platform (K143308) | Applied Medical Resources | 2015-10-13 |
| VISERA 4K UHD SYSTEM (K151011) | Olympus Medical Systems Corp. | 2015-10-01 |
| Sydney IVF PVP (K152440) | Willam A. Cook Australia Pty, Ltd. | 2015-09-23 |