| Magnetic Surgical System (K190006) | Levita Magnetics International Corp | 2019-04-29 |
| Cardinal HealthTM Poly-Coated Open-Back Protective Gown (K182830) | Cardinal Health200, LLC | 2019-04-26 |
| Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), Medline Level 4 Surgical Gown (Aurora) (K182172) | Medline Industries, Inc. | 2019-04-24 |
| V-Laser (K183156) | Wontech Co., Ltd. | 2019-04-24 |
| IntelliCartTM System (K190789) | Dornoch Medical Systems | 2019-04-24 |
| CryoLab (K190407) | Cryoconcepts LP | 2019-04-22 |
| PREVENA 125 and PREVENA PLUS 125 Therapy Units (DEN180013) | Kci USA, Inc. | 2019-04-19 |
| CryoTouch (K183601) | Cryoconcepts LP | 2019-04-18 |
| Linear Cutter Staplers and Loading Units for Single Use, Circular Staplers for Single Use (K182217) | Ezisurg (Suzhou) Medical Co., Ltd. | 2019-04-16 |
| Diode Laser Treatment System (K182924) | Weifang KM Electronics Co., Ltd. | 2019-04-15 |
| Codman Electrosurgical Generator, Foot Pedal (K183526) | Kls Martin GmbH + Co. KG | 2019-04-11 |
| Endoform Restella (K183398) | Aroa Biosurgery , Ltd. | 2019-04-11 |
| Ergoline Sunrise 7200 Hybrid Technology (K183539) | Jk-Holding GmbH | 2019-04-08 |
| Erbe APCapplicators (K183445) | Erbe Elektromedizin GmbH | 2019-04-04 |
| BTL-084 (K190023) | BTL Industries, Inc. | 2019-03-29 |
| Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy Drugs (K182176) | Pt. Medisafe Technologies | 2019-03-28 |
| V.A.C. DERMATAC Drape (K181505) | Kci USA, Inc. | 2019-03-28 |
| MiMo(TM) Negative Pressure Wound Therapy System (K181929) | Baymax Research, Inc. | 2019-03-27 |
| WaveLight FS200 Patient Interface (K190392) | Alcon Laboratories, Inc. | 2019-03-26 |
| EnVisio Navigation Sytem (K183400) | Elucent Medical, Inc. | 2019-03-22 |
| Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs (K182948) | Ansell Healthcare Products, LLC | 2019-03-22 |
| RENASYS Touch; RENASYS Y-Connector (K181822) | Smith & Nephew Medical Limited | 2019-03-21 |
| ACTIV.A.C. Therapy Unit (K183543) | Kci USA, Inc. | 2019-03-20 |
| BRAUN Silk Expert Pro 3 (K190366) | Cyden Limited | 2019-03-18 |
| BRAUN Silk.expert Pro 5 (K190354) | Cyden Limited | 2019-03-18 |
| Sensilight Pro / Pistol IPL (K183260) | El Global Trade, Ltd. | 2019-03-18 |
| MTF Pre-Sutured Tendon (K181633) | Musculoskeletal Transplant Foundation | 2019-03-15 |
| Signia Circular Adapters (for use with Signia Staplers), Tri-Staple 2.0 Circular Reloads (for use with Signia Circular Adapters) (K182475) | Covidien | 2019-03-14 |
| dpl Faceware (K183247) | Led Technologies, Inc. | 2019-03-14 |
| Aquas Probes (K190168) | Genicon, Inc. | 2019-03-14 |
| DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio – MR Conditional (K183472) | Synthes (USA) Products, LLC | 2019-03-13 |
| FasTouch Absorbable Fixation System (K181668) | Via Surgical , Ltd. | 2019-03-13 |
| Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open handpieces, Renuvion/J-Plasma Precise Open handpieces (K183610) | Bovie Medical Corporation | 2019-03-12 |
| Caiman 5 Maryland (K183180) | Aesculap, Inc. | 2019-03-12 |
| EasyInstruments (K182013) | Agency For Medical Innovations GmbH | 2019-03-11 |
| HANAROSTENT LowAx Colon/Rectum (NNN) (K190141) | M.I.Tech Co., Ltd. | 2019-03-07 |
| Joule System (K182173) | Sciton, Inc | 2019-03-06 |
| Vydence Laser Family (K190007) | Vydence Medical Industria E Comercio Ltda | 2019-03-01 |
| Solero MTA Cart, Solero MTA System, Solero microwave Tissue Ablation Applicator (14cm), , Solero microwave Tissue Ablation Applicator (19cm), Solero microwave Tissue Ablation Applicator (29cm) (K182250) | AngioDynamics, Inc. | 2019-02-28 |
| ClariFix (K190356) | Arrinex, Inc. | 2019-02-26 |
| COBRA Fusion Ablation System (K190151) | AtriCure, Inc. | 2019-02-25 |
| Doctor Tecar (K183693) | Mectronic Medicale S.R.L. | 2019-02-22 |
| Empower RF Catheter (K183240) | Broncus Medical, Inc. | 2019-02-22 |
| ZOOM Aspiration Pump (K190105) | Taiwan Biomaterial Co., Ltd. | 2019-02-21 |
| Laparoscopic Curved Spatula Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Wire J-Hook Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Wire L-Hook Electrode, Retractable, Aspiration Hole, 28cm; Laparoscopic Wire L-Hook Electrode, Retractable, Aspiration, 36cm ; Laparoscopic Flat L-Hook Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Straight Spatula Electrode, Hollow, 28cm ; Laparoscopic Curved Spatula Electrode, Hollow, 28cm; Laparoscopic Wire J (K183594) | New Deantronics Taiwan , Ltd. | 2019-02-19 |
| PREVENA RESTOR(TM) Incision Management System (K181507) | Kci USA, Inc. | 2019-02-15 |
| IPL Hair Removal Device (K183217) | Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. | 2019-02-15 |
| Aurora Evacuator (K190075) | Rebound Therapeutics | 2019-02-12 |
| easyPPHTM Hemorrhoidal Stapler for Single Use (K183477) | Ezisurg Medical Co., Ltd. | 2019-02-11 |
| ArcTV Transvaginal Sling System (K183134) | Urocure, LLC | 2019-02-07 |
| SafeAir Smoke Evacuator compact (K182224) | Lina Medical Aps | 2019-02-07 |
| dpl SpotLite (K183118) | Led Technologies, Inc. | 2019-02-07 |
| Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal (K182259) | Acell, Inc. | 2019-02-07 |
| Echelon Endoscopic Linear Cutter Reloads, White, Blue, Gold, Green and Black (K183435) | Ethicon Endo-Surgery, LLC | 2019-02-06 |
| Invia Abdominal Dressing Kit (K182191) | Medela AG | 2019-02-01 |
| Family of Venus RF Systems - Heal (K182094) | Venus Concept USA, Inc. | 2019-02-01 |
| easyLCTM Linear Cutter Staplers and Loading Units fot Single Use; easyCSTM Circular Stapler for Single Use (K181657) | Ezisurg Medical Co., Ltd. | 2019-02-01 |
| Vbeam Prima Laser System (K183452) | Candela Corp. | 2019-02-01 |
| T-PLUS (K181893) | Wintecare SA | 2019-01-29 |
| WEGO-PGLA RAPID (K183001) | Foosin Medical Supplies Inc., Ltd. | 2019-01-28 |
| WEGO-PGA RAPID (K183004) | Foosin Medical Supplies Inc., Ltd. | 2019-01-28 |
| FLOW 90 Wand (K183346) | ArthroCare Corporation | 2019-01-24 |
| Surgical Face Mask (K182514) | Xiantao Zhibo Non-Woven Products Co., Ltd. | 2019-01-24 |
| LG PRA.L DERMA LED MASK (K183671) | Lg Electronics.Inc | 2019-01-22 |
| PICO 7Y Single Use Negative Pressure Wound Therapy System (K182323) | Smith & Nephew Medical Limited | 2019-01-18 |
| VIVA combo RF System (K183538) | Starmed Co., Ltd. | 2019-01-17 |
| SIRA RFA Electrosurgical Device (K181071) | Innoblative Designs, Inc. | 2019-01-16 |
| Disposable Ultra Reinforced Surgical Gown (K173847) | Xiantao Rayxin Medical Products Co., Ltd. | 2019-01-16 |
| OsteoCool RF Ablation System (K182497) | Medtronic Sofamor Danek USA, Inc. | 2019-01-15 |
| ZELTIQ CoolSculpting System (K183514) | Zeltiq Aesthetics, Inc. | 2019-01-14 |
| ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER) (K182453) | I-Tech Industries Srl | 2019-01-11 |
| Applied Tissue Technologies PWD™ Platform Wound Dressing (K182409) | Applied Tissue Technologies, LLC | 2019-01-11 |
| UV Phototherapy (K181805) | Xuzhou Kernel Medical Equipment Co., Ltd. | 2019-01-11 |
| STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Knotless Tissue Control Devices (K182873) | ETHICON, Inc. | 2019-01-10 |
| RENASYS Y-Connector; RENASYS TOUCH (K181204) | Smith & Nephew Medical Limited | 2019-01-10 |
| HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN) (K183616) | M.I.Tech Co., Ltd. | 2019-01-10 |
| Powder Free White, Blue Sterilized Nitrile Copolymer Surgical Gloves Tested for Use with Chemotherapy Drugs (K181047) | Smart Glove Corporation Sdn. Bhd. | 2019-01-09 |
| PicoLO Nd:YAG Picosecond Laser System (K183392) | Laseroptek Co., Ltd. | 2019-01-04 |
| SculpSure (K182741) | Cynosure | 2019-01-03 |
| Cufitec Surgical Mask (K182766) | Nbc Meshtec, Inc. | 2019-01-03 |
| Lotus III Multi-Pulsed Er: Yag Laser System (K182045) | Laseroptek Co., Ltd. | 2018-12-27 |
| REXLENE (K173747) | Sm Eng Co., Ltd. | 2018-12-21 |
| FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal Aspirator (K180863) | Taidoc Technology Corporation | 2018-12-19 |
| Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device, Cardioblate LP Surgical Ablation Device (K182610) | Medtronic | 2018-12-19 |
| SafeAir Telescopic Smoke Pencil (K182354) | Lina Medical Aps | 2018-12-14 |
| Phasix ST Mesh with Echo 2 Positioning System (K182008) | C.R. Bard, Inc. | 2018-12-14 |
| BTL-FR2000 (K180359) | BTL Industries, Inc. | 2018-12-13 |
| enlighten III Laser System (K182997) | Cutera, Inc. | 2018-12-12 |
| Medline Cautery Electrode (SILICONE) (K182812) | Medline Industries, Inc. | 2018-12-12 |
| Magma Spark Pro (Magma Spark Plus, Alpha) (K183307) | Formatk Systems , Ltd. | 2018-12-11 |
| Mygen V-1000 RF System (K180999) | RF Medical Co., Ltd. | 2018-12-11 |
| SabreLine and SabreGuard Laser Fibers (K182831) | Coloplast Corp. | 2018-12-10 |
| LUTRONIC GENIUS Radiofrequency System (K180945) | Lutronic Corporation | 2018-12-10 |
| SignalMark Lung Biopsy Site Marker (K180175) | View Point Medical, Inc. | 2018-12-07 |
| Endoform Reconstructive Template - Non Absorbable (K181935) | Aroa Biosurgery , Ltd. | 2018-12-04 |
| Coolrail Linear Pen (K183065) | AtriCure, Inc. | 2018-12-04 |
| Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System (K182663) | Finemec Co., Ltd. | 2018-11-30 |
| Advanced Skin Renewing Device (K182498) | Jiangsu Unimed Laser Technology Co., Ltd. | 2018-11-30 |
| UNO Negative Pressure Wound Therapy System (K180840) | Genadyne Biotechnologies, Inc. | 2018-11-30 |
| Thoraguard System (K181667) | Centese, Inc. | 2018-11-29 |