| LT Antibacterial Alginate with Silver Dressing (K192478) | Zhejiang Longterm Medical Technology Co., Ltd. | 2020-06-17 |
| SleepRight ProRx Custom Dental Guard (K193577) | Splintek, Inc. | 2020-06-01 |
| Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse (K193336) | Synedgen, Inc. | 2020-05-27 |
| TRV (K192652) | Interacoustics A/S | 2020-05-27 |
| Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing with Border (K191819) | Winner Medical Co., Ltd. | 2020-05-14 |
| PHMB Foam Dressing Non-Adhesive, PHMB Foam Dressing Adhesive, Silicone PHMB Foam Dressing, Silicone PHMB Foam Dressing with Border (K192463) | Winner Medical Co., Ltd. | 2020-05-14 |
| PuraDERM Gel (K193085) | 3-D Matrix, Inc. | 2020-05-11 |
| PELNAC Bilayer Wound Matrix (K191992) | Gunze Limited | 2020-04-29 |
| Vapocoolshot Mist (K193349) | Vapocoolshot, Inc. | 2020-04-14 |
| HBP6 Settable, Resorbable Hemostatic Bone Paste (K193052) | Orthocon, Inc. | 2020-03-27 |
| AC5 Topical Gel (K190129) | Arch Therapeutics, Inc. | 2020-03-11 |
| Vista Clear (K193389) | Inter-Med/Vista Dental Products | 2020-03-04 |
| TumEase Acupressure Bracelets (K193374) | Mumease | 2020-03-04 |
| scaffolene CL100 Bioresorbable Collagen Matrix (K192346) | Freudenberg Technology Innovation SE & Co. KG | 2020-02-28 |
| HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36 cm length (K191555) | Ethicon Endo-Surgery, LLC | 2020-02-28 |
| Biatain Silicone Ag (K191536) | Coloplast A/S | 2020-02-21 |
| Rochal Antimicrobial Wound Gel (K192527) | Rochal Industries, LLC | 2020-02-07 |
| Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc (K191498) | Cook Incorporated | 2020-01-29 |
| Dental Pain Eraser (K193570) | Synapse Dental | 2020-01-17 |
| ClenchGuard (K181005) | Boyd Research, Inc. | 2020-01-15 |
| Dental Pain Eraser (K192429) | Synapse Dental | 2020-01-14 |
| Spinalytics (K192629) | Optima Health Solutions International Corp. | 2019-12-21 |
| IODOSORB (K190730) | Smith & Nephew Medical, Ltd. | 2019-12-20 |
| Ceramill A-Splint (K191836) | Amann Girrbach AG | 2019-12-20 |
| IODOFLEX (K190756) | Smith & Nephew Medical, Ltd. | 2019-12-20 |
| OMNI-STAT Vascular (Rapid); CELOX Vascular Rapid (K190012) | Medtrade Product, Ltd. | 2019-12-18 |
| CORRIDOR Fixation System (K192744) | Globus Medical, Inc. | 2019-12-16 |
| Lawson Retrograde Nephrostomy Wire Puncture Set (K190903) | Cook Incorporated | 2019-12-16 |
| NasalCEASE and BleedCEASE (K183622) | Les Laboratoires Brothier S.A. | 2019-12-02 |
| Orapeutic (K191987) | Forward Science | 2019-11-27 |
| CVS Health Dry Mouth Spray, OraLabs Dry Mouth Spray (K181839) | Oralabs, Inc. | 2019-11-21 |
| AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine System, BOWTI Anterior Buttress Staple Spinal System, DISCOVERY Screw System, EXPEDIUM Anterior Spine System, FRONTIER Anterior Scoliosis System, KANEDA Anterior Scoliosis System, KANEDA SR Anterior Spinal System, M-2 Anterior Plate System, MOUNTAINEER Laminoplasty System, PROFILE Anterior Thoracolumbar Plate System, UNIVERSITY PLATE Anterior System, VIPER F2 Facet Fixation System (K192281) | Medos International SARL | 2019-11-20 |
| KeyPrint KeySplint Soft (K183598) | Keystone Industries | 2019-11-15 |
| AMICUS Separator System (K192150) | Fresenius Kabi AG | 2019-11-13 |
| Hydrofera Blue READY - Border (K190268) | Hydrofera, LLC | 2019-11-06 |
| MucoPEG (K190144) | Sunbio, Inc. | 2019-11-05 |
| Ultrasonic Surgical System (K190281) | Medisonic Technology CO | 2019-10-31 |
| gel-e Flex+ gel OTC (K192667) | Gel-E, Inc. | 2019-10-25 |
| Cytal Wound Matrix 3-Layer (K192725) | Acell, Inc. | 2019-10-25 |
| Tear Pool Dissolvable Punctum Plugs (K190210) | Alphamed, Inc. | 2019-10-24 |
| ClearEdge Balance System (K183661) | Quadrant Biosciences | 2019-10-22 |
| BIAFINE Topical Cream (K190342) | Bausch Health Americas Incorporated | 2019-10-18 |
| Protego Antimicrobial Wound Dressing (K183681) | Global Health Solutions (Dba Turn Therapeutics) | 2019-10-11 |
| PMT Facet Screw (K183589) | Providence Medical Technology, Inc. | 2019-10-11 |
| Propex IQ Apex Locator (K191806) | Dentsply Sirona | 2019-10-03 |
| Clyra Wound Irrigation Solution (K181428) | Clyra Medical Technologies, Inc. | 2019-09-20 |
| OraCure (K183436) | Tbm Corporation | 2019-09-18 |
| Roosin Xeroform Petrolatum Dressing (K181478) | Roosin Medical Co., Ltd. | 2019-09-13 |
| Saline Wound Wash, SteriCleanse(TM) (K183662) | Ascent Consumer Products, Inc. | 2019-09-12 |
| gel-e Flex+ (K182811) | Gel-E, Inc. | 2019-08-29 |
| CryoVizion System (K183485) | Cryos Technologies, Inc. | 2019-08-28 |
| CustMBite Dental Guard (K183315) | Dental Choice Holdings, LLC | 2019-08-23 |
| EQ Balance (K190735) | Upright Science, Inc. | 2019-08-16 |
| Suprasorb A + Ag “R” (K183208) | Speciality Fibres and Materials, Ltd. | 2019-08-15 |
| Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology (K190610) | Sterilmed, Inc. | 2019-08-15 |
| LunaGuard Nighttime Dental Protector (K191033) | Mckeon Products | 2019-08-05 |
| Silicone PHMB Foam Wound Dressing (K190819) | Advanced Medical Solutions, Ltd. | 2019-07-25 |
| Silverlon Wound Contact, Burn Contact Dressings (K190343) | Argentum Medical, LLC | 2019-07-18 |
| MONTAGE-QS Settable, Resorbable Hemostatic Bone (K191140) | Orthocon, Inc. | 2019-07-18 |
| The POD (K182820) | Advanced Facialdontics, LLC | 2019-07-17 |
| Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set (K183051) | Cook Incorporated | 2019-07-16 |
| VeriSplint (K190107) | Whip Mix Corporation | 2019-07-10 |
| MariGen Wound Extra (K190528) | Kerecis Limited | 2019-07-10 |
| Vista FS, Vista FS Liquid (K190220) | Inter-Med/Vista Dental Products | 2019-06-10 |
| Apis (K182725) | Sweetbio, Inc. | 2019-05-31 |
| neXus Ultrasonic Surgical Aspirator System (K190160) | Misonix, Inc. | 2019-05-30 |
| Silver High Performance Dressing (K183645) | Advanced Medical Solutions, Ltd. | 2019-05-29 |
| Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Trocar Needle (K183035) | Cook Incorporated | 2019-05-17 |
| Ethyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoint spray, Ethyl Chloride Mist, Ethyl Chloride Accustream 360* Medium Spray, Ethyl Chloride Accustream 360* Fine Spray (K190161) | Gebauer Company | 2019-05-07 |
| Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis (K182272) | Sterilmed, Inc. | 2019-04-15 |
| Brux Night Guard (K181361) | Brux Night Guard | 2019-04-11 |
| Sonopet iQ Ultrasonic Aspirator System (K190070) | Stryker Corporation | 2019-04-11 |
| CUSA Clarity Ultrasonic Surgical Aspirator System (K190180) | Integra LifeSciences Corporation | 2019-04-01 |
| Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent Set (K181735) | Cook Incorporated | 2019-03-27 |
| Dental Pain Eraser (K182947) | Synapse Dental, LLC | 2019-03-26 |
| Medline Burn and Wound Dressing (OTC) (K190224) | Medline Industries, Inc. | 2019-03-08 |
| SmartMouth DryMouth Oral Rinse (K181194) | Triumph Pharmaceuticals, Inc. | 2019-02-15 |
| Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing, Antimicrobial non-woven sponge dressing (K181315) | Winner Medical Co., Ltd. | 2019-02-14 |
| Spectra Optia Apheresis System (K183081) | Terumobct, Inc. | 2019-02-05 |
| Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix (K183163) | Motiva USA, LLC | 2019-02-05 |
| Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay (K181135) | Immunalysis Corporation | 2019-01-24 |
| Bright Guard (K181099) | Koncept Innovators, LLC | 2019-01-18 |
| ProgenaMatrix (K182010) | Cell Constructs I, LLC | 2019-01-17 |
| Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as Silverlon Burn Pad Dressing) (K180570) | Argentum Medical, LLC | 2019-01-14 |
| Raycell MK1 (K181737) | Best Theratronics Limited | 2019-01-02 |
| QuikClot Radial (K181641) | Z-Medica, LLC | 2018-12-24 |
| Natrelle 133 Plus MICROCELL Tissue Expander (K180826) | Allergan | 2018-12-21 |
| Apex Locator, DPEX III (K181087) | Guilin Woodpecker Medical Instrument Co., Ltd. | 2018-12-18 |
| AC5 Topical Gel (K182681) | Arch Therapeutics, Inc. | 2018-12-14 |
| Procellera Composite Antibacterial Wound Dressing (K180533) | Vomaris Wound Care, Inc. | 2018-12-10 |
| CUSA Clarity Ultrasonic Surgical Aspirator System (K182809) | Integra LifeSciences Corporation | 2018-12-07 |
| KerraContact Ag Perf Advanced Perforated Silver Wound Dressing (K182680) | Exciton Technologies, Inc. | 2018-12-06 |
| AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter (K180615) | Fresenius Kabi USA,Llc | 2018-12-04 |
| MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs) (K180643) | Medcu Technologies , Ltd. | 2018-11-23 |
| Geistlich Derma-Gide (K182838) | Geistlich Pharma AG | 2018-11-08 |
| Spectra Optia Apheresis System (K181049) | Terumobct, Inc. | 2018-11-01 |
| Salivea Dry Mouth Mouthwash, Salivea Dry Mouth Mouthspray (K180680) | Laclede, Inc. | 2018-10-11 |
| NeoMatriX Wound Matrix (K181330) | Nextgen Biologics, Inc. | 2018-10-11 |
| CPX 4 Breast Tissue Expander with Smooth Surface (K182335) | Mentor Worldwide, LLC | 2018-09-25 |
| IHM Technology Bandage (K180893) | Protege Biomedical | 2018-09-19 |