| UNO 30 (K190028) | Genadyne Biotechnologies | 2020-01-15 |
| INTRAcel RF Microneedle System (K183284) | Jeisys Medical, Inc. | 2020-01-15 |
| XTRAC Momentum Excimer Laser System (K193478) | Strata Skin Sciences, Inc. | 2020-01-14 |
| Erchonia Emerald (K192544) | Erchonia Corporation | 2020-01-13 |
| ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO 2 footswitch; Flexible Cryoprobe; ERBECRYO 2 Cart, VIO-Cart, Wire basket; Connecting hoses, switching valves, adapter (K190651) | Erbe Elektromedizin GmbH | 2020-01-07 |
| CRF Radiofrequency Ablation System (K192715) | Cambridge Interventional, LLC | 2020-01-07 |
| NeuroBlate System (K193375) | Monteris Medical, | 2020-01-03 |
| PALLAS 308/311 Solid-State UV Laser System (K191501) | Laseroptek Co., Ltd. | 2020-01-03 |
| Sterile Latex Surgical Glove, Powder Free (K190241) | Careglove Global Sdn. Bhd. | 2019-12-30 |
| Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft (K191696) | Cook Biotech Incorporated | 2019-12-27 |
| InMode System with the Morpheus8 (Fractora) Applicators (K192695) | Inmode MD , Ltd. | 2019-12-27 |
| TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool (K190884) | Datascope Corp. | 2019-12-26 |
| Dannik Titanium Ligation Clip (K192711) | Dannik | 2019-12-20 |
| Surgical Direct Hand-held Laparoscopic Instruments (K193018) | Surgical Direct, Inc. | 2019-12-20 |
| Voyant 5mm Fusion Device, Voyant Maryland Fusion Device (K193292) | Applied Medical Resources Corp. | 2019-12-20 |
| Litho Evo (K192990) | Quanta System Spa | 2019-12-20 |
| APC 3 Argon Plasma Coagulation Unit, VIO 3 Electrosurgical Unit, FiAPC probes, Hybrid APC, APCapplicators, APC Pressure Reducer with Sensor, VIO Cart, Fastening sets (K191234) | Erbe Elektromedizin GmbH | 2019-12-20 |
| IceSense 3, ProSense, MultiSense (K183213) | IceCure Medical , Ltd. | 2019-12-20 |
| Soli-Lite LG4 Galileo (K192755) | Silhouet-Tone Corporation | 2019-12-20 |
| RHIN1 Stylus (K192471) | Aerin Medical, Inc. | 2019-12-20 |
| WEREWOLF COBLATION System, COBLATION HALO Wand (K192027) | ArthroCare Corporation | 2019-12-20 |
| Monopolar Cord (K193004) | New Deantronics Taiwan , Ltd. | 2019-12-19 |
| Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (K182476) | Fengh Medical Co., Ltd. | 2019-12-18 |
| Sterile Latex Powder-Free Surgical Gloves (K191898) | Modern Healthcare Corp. | 2019-12-18 |
| STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device (K192580) | ETHICON, Inc. | 2019-12-18 |
| Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG) (K192615) | Synovis Life Technologies, Inc. (Baxter International Inc.) | 2019-12-17 |
| Deka Luxea (K192539) | El.En Electronic Engineering Spa | 2019-12-16 |
| Diode Laser Therapy System (K192569) | San HE Lefis Electronics Co., Ltd. | 2019-12-13 |
| EPIFLO-28 (K190742) | Neogenix, LLC Dba Ogenix | 2019-12-13 |
| Aero Blue Performance Surgical Gowns (K192362) | O&M Halyard, Inc. | 2019-12-13 |
| EPi-Sense Guided Coagulation System with VisiTrax (K193162) | AtriCure, Inc. | 2019-12-13 |
| Demetra BDEM-01 Dermatoscope (K192829) | Barco N.V. | 2019-12-13 |
| Exciplex (K191086) | Clarteis | 2019-12-11 |
| Diode Laser 808nm (K192516) | Beijing Superlaser Technology Co., Ltd. | 2019-12-10 |
| Intense Pulsed Light Treatment System (K192521) | Shangdong Huamei Technology Co., Ltd. | 2019-12-06 |
| Dextile Anatomical Mesh (K192443) | Sofradim Production | 2019-12-06 |
| BTL-899 (K192224) | Btl | 2019-12-05 |
| Vitra 2 (K191962) | Quantel Medical | 2019-12-05 |
| PICO 14 Single Use Negative Pressure Wound Therapy System (K191760) | Smith & Nephew Medical Limited | 2019-12-05 |
| MolecuLight i:X (K191371) | MolecuLight, Inc. | 2019-12-04 |
| Epic 980 (K192430) | Biolase, Inc. | 2019-12-04 |
| Deka Tiac 1 (K183371) | El..En. Electroic Engineering Spa | 2019-12-03 |
| Promisemed Heel Blood Lancet (K193009) | Promisemed Hangzhou Meditech Co., Ltd. | 2019-12-03 |
| CO2 Laser Therapy System (K192528) | Shangdong Huamei Technology Co., Ltd. | 2019-12-03 |
| Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip (K192374) | Cardinal Health200, LLC | 2019-12-02 |
| Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet (K192666) | Promisemed Hangzhou Meditech Co., Ltd. | 2019-12-02 |
| Innonix Antiviral Child's Face Mask (K192105) | Innonix Technologies Limited | 2019-11-29 |
| Multi-modality workstation (K192519) | Beijing Superlaser Technology Co., Ltd. | 2019-11-27 |
| OrthoGold (K191961) | Tissue Regeneration Technologies | 2019-11-26 |
| PREVENA PLUS Incision Management System (No Ag); PREVENA PLUS DUO Incision Management System (No Ag) (K190697) | Kci USA, Inc. | 2019-11-22 |
| Applied Medical Laparoscopic Linear Cutter (K190331) | Applied Medical Resources Corporation | 2019-11-22 |
| Canady Plasma SMART XL-1000 Electrosurgical Generator with Accessories (K192124) | Us Medical Innovations, LLC | 2019-11-21 |
| TwinScan 808/755 Laser System (K192269) | Gme German Medical Engineering GmbH | 2019-11-19 |
| JTL-250-01 (K182732) | Jointechlabs, Inc. | 2019-11-18 |
| LaseMD LEO Laser System (K192331) | Lutronic Global | 2019-11-12 |
| IPL Home Use Hair Removal Device Model(s): D-1128, D-1103, D-1119, D-1129, D-1130 (K192432) | Shenzhen Bosidin Technology Co., Ltd. | 2019-11-08 |
| Progenikine Concentrating System 25 mL System (K191564) | Emcyte Corporation | 2019-11-07 |
| DemeDIOX Barbed Absorbable Surgical Suture (K191361) | Demetech Corporation | 2019-11-07 |
| Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen (K192125) | AtriCure, Inc. | 2019-11-04 |
| BC-5 (K191693) | Reveallux, Corp | 2019-11-01 |
| Foryou NPWT Dressing Kit (K190119) | 4l Health Co., Ltd. | 2019-11-01 |
| Apyx Helium Plasma Generator (APYX-200H/P, APYX-JS3/RS3) (K192867) | Bovie Medical Corporation Dba Apyx Medical Corporation | 2019-10-31 |
| Claritag (K190747) | Dgi Technologies | 2019-10-31 |
| EmFace Device (K191855) | Inmode MD , Ltd. | 2019-10-29 |
| KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun (K191881) | Kbl GmbH | 2019-10-28 |
| HS AMICA devices family (K182605) | H.S Hospital Service S.P.A | 2019-10-28 |
| Reusable Monopolar Active Cord (K192518) | Us Endoscopy | 2019-10-25 |
| Agnes (K192728) | Agnes Medical Co., Ltd. | 2019-10-24 |
| Latex Surgeon’s Gloves Powder Free with protein content labeling claim of 50µg/dm2 or less per glove of extractable protein (K190632) | Lenora Glove Pvt , Ltd. | 2019-10-24 |
| Patient-Specific Airway Stent (K182743) | New Cos, Inc. | 2019-10-23 |
| VICRYL Mesh (K191373) | ETHICON, Inc. | 2019-10-22 |
| Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter (K191073) | Vein 360, LLC | 2019-10-22 |
| CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Envelope (extra extra large) (SubQ) (K192616) | Aziyo Biologics, Inc. | 2019-10-21 |
| LIPOcel (K181896) | Jeisys Medical, Inc. | 2019-10-18 |
| EasyMark Tissue Marker (K183503) | Inrad, Inc. | 2019-10-17 |
| MT One Diamond (K191942) | M&T S.R.L. | 2019-10-17 |
| Reach and CQ'ENCE Circular Staplers (K192566) | Reach Surgical, Inc. | 2019-10-17 |
| TotalShield II Surgical Helmet System (K192194) | Zimmer Surgical, Inc. | 2019-10-15 |
| Echelon Endopath Staple Line Reinforcement (K190937) | Ethicon Endo-Surgery, LLC | 2019-10-14 |
| Apyx Plasma/RF Handpiece (K191542) | Bovie Medical Corporation Dba Apyx Medical Corporation | 2019-10-11 |
| AEON Laparoscopic Instruments (K192235) | Lexington Medical, Inc. | 2019-10-11 |
| KTA Adipose Treatment Kit (K190386) | Stemics S.A.S | 2019-10-10 |
| Mercy babyTAPE (K191174) | Children'S Mercy Hospital | 2019-10-10 |
| Waterlase Laser System Family (K190319) | Biolase, Inc. | 2019-10-10 |
| The Cellfina System (K192185) | Ulthera, Inc. | 2019-10-09 |
| Barrier Sleeves (K191448) | Ivoclar Vivadent, AG | 2019-10-08 |
| Single-Use Non-Stick Bipolar forceps Bayonet, Single-Use Non-Stick Bipolar Irrigating forceps, Single Use Non-Stick Bipolar Suction forceps (K182773) | Faulhaber Pinzetten Ohg | 2019-10-08 |
| Sutter Arrowtip Monopolar Electrodes (K192128) | Sutter Medizintechnik GmbH | 2019-10-04 |
| Aimanfun Lumea Comfort (K190820) | Kam Yuen Plastic Products , Ltd. | 2019-10-02 |
| Cardioblate CryoFlex Surgical Ablation System (K191526) | Medtronic, Inc. | 2019-10-01 |
| XLR8 Abdominal Wound Dressing Kit (K182722) | Genadyne Biotechnologies | 2019-09-27 |
| FlexBand Plus (K192112) | International Life Sciences | 2019-09-27 |
| BioZorb SP Marker (K192371) | Focal Therapeutics | 2019-09-26 |
| Exogenesis Hernia Mesh (K191545) | Exogenesis Corporation | 2019-09-26 |
| NuStat (K183190) | Beeken Biomedical, LLC | 2019-09-25 |
| SmoothSkin BARE+ (K192010) | Cyden Limited | 2019-09-24 |
| Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks, Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1) (K190308) | Amd Medicom, Inc. | 2019-09-17 |
| VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar Extension Cable, Fixed Distance, Active Return Cord (K191947) | Maquet Cardiovascular, LLC | 2019-09-17 |
| Poly Clear (K183708) | Medtek Skincare, LLC | 2019-09-17 |
| Discovery Pico, Discovery Pico Plus, Discovery Pico Derm (K191842) | Quanta System Spa | 2019-09-17 |