| MONTAGE Settable, Resorbable Hemostatic Bone Putty (K152005) | Orthocon, Inc. | 2015-10-15 |
| SICAT OPTIMOTION (K143655) | Sicat GmbH & Co. KG | 2015-10-02 |
| Ready-Fit (K151149) | Den Tek Oral Care, Inc. | 2015-09-30 |
| Astringedent Clear (K152064) | Ultradent Products, Inc. | 2015-09-24 |
| XEROSTOM SALIVA SUBSTITUTE GEL (K142657) | Bio Cosmetics, S.L. | 2015-09-14 |
| Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC Connection), Spectra Optia AC Connection Adapter (K151368) | Terumo Bct | 2015-09-11 |
| Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators (K152176) | Immunalysis Corporation | 2015-09-04 |
| CleanSmart Wound Cleanser (K142592) | Simple Science, LLC | 2015-09-02 |
| Dynarex Eye Cups (K151575) | Dynarex Corporation | 2015-09-01 |
| PDO Absorbable Punctum Plug (K150288) | Riverpoint Medical | 2015-08-28 |
| SynePure Wound Cleanser (K143444) | Synedgen, Inc. | 2015-08-21 |
| Natrelle 133 Plus Tissue Expander (K143354) | Allergan, Inc. | 2015-08-20 |
| Cook ECM Powder (K152033) | Cook Biotech Incorporated | 2015-08-19 |
| Narval Brux (K143623) | Resmed Sas | 2015-08-13 |
| Urgoclean Ag, Antibacterial Absorbent Wound Dressing with Silver (K143017) | Laboratoires Urgo | 2015-08-07 |
| LEECH, MEDICINAL (K140907) | Carolina Biological Supply Co. | 2015-08-07 |
| Cornea Cold (K151061) | Eurobio | 2015-08-06 |
| HEMO-Bandage (K151204) | Coreleader Biotech Co., Ltd. | 2015-07-31 |
| PROTOCOL Incision Dressing (K142962) | Deroyal Industries | 2015-07-23 |
| Lotus Series 4 Ultrasonic Surgical System & Accessories (K151101) | Sra Developments, Ltd. | 2015-07-17 |
| HARMONIC Focus Long Shears + Adaptive Tissue Technology (K151340) | Ethicon Endo-Surgery, LLC | 2015-07-10 |
| EXPAZEN (K150423) | Produits Dentaires Pierre Rolland (Acteon Group) | 2015-07-08 |
| XENOMEM WOUND MATRIX (K140820) | Viscus Biologics, LLC | 2015-06-26 |
| MEDIHONEY WOUND DRESSINGS (K133279) | Derma Sciences, Inc. | 2015-06-25 |
| Elevate Moisturizing Spray (K150074) | Elevate Oral Care | 2015-06-19 |
| Hemogrip Patch (K143466) | Remedium Technologies, Inc. | 2015-06-08 |
| Alevicyn SG Antipruritic Gel (K143590) | Oculus Innovative Sciences | 2015-06-04 |
| SPB SKIN EMULSION (K141637) | Biotd S.A. | 2015-06-03 |
| Roosin Silver Calcium Alginate Dressing (Prescription), Roosin Alginate Dressing with Preservative (OTC) (K143335) | Roosin Medical Devices Co., Ltd. | 2015-06-01 |
| Prime Adaptive Ultrasonic Scalpel System (K150271) | Endoprime, Inc. | 2015-05-29 |
| Oral7 Moisturizing Gel, Oral7 Moisturizing Mouthwash, Oral7 Moisturizing Mouth Spray, Oral7 Toothpaste (K142549) | J.C.E.C. Company, Inc. (Doing Business AS Fountain Health CA | 2015-05-26 |
| Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILE (K151055) | Mentor Worldwide, LLC | 2015-05-20 |
| Reprocessed Cordless Ultrasonic Dissection Device (K143562) | Sterilmed, Inc. | 2015-05-20 |
| ANSISTIM (K141168) | Dyansys, Inc. | 2015-05-15 |
| PURICORE WOUND HYDROGEL SPRAY DRESSING (K141863) | Puricore, Inc. | 2015-05-14 |
| AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use) (K143462) | Benq Materials Corporation | 2015-05-08 |
| DERMAFINE (K140905) | Invado Pharmaceuticals | 2015-05-08 |
| SILVERLON BURN CONTACT DRESSINGS (K150256) | Argentum Medical | 2015-04-30 |
| Facet-Link Stabilization Platform (K150223) | Facet-Link, Inc. | 2015-04-28 |
| Artoura Breast Tissue Expander (K150777) | Mentor Worldwide, LLC | 2015-04-24 |
| IPM Wound Gel Bio, IPM Derm Gel Bio (K143527) | Glycobiosciences, Inc. | 2015-04-20 |
| LUOFUCON SILVER FOAM DRESSING (K141619) | Huizhou Foryou Medical Devices Co., Ltd. | 2015-04-06 |
| LUOFUCON SILVER PU ANTIBACTERIAL FOAM DRESSING (K140954) | Huizhou Foryou Medical Devices Co., Ltd. | 2015-03-23 |
| SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET (DISPOSABLE BLOOD TUBING SET) (K141938) | Terumobct, Inc. | 2015-03-23 |
| Irritrol, EDS Combo-Rinse (K150020) | Essential Dental Systesm, Inc. | 2015-02-25 |
| MEDEOR MATRIX WOUND DRESSING (K141738) | Kensey Nash Corporation Dba Dsm Biomedical | 2015-02-17 |
| PuraDerm Gel (K143058) | 3-D Matrix, Inc. | 2015-02-13 |
| Neuwater TM (HydrocynTM aqua) (K142775) | Vigilenz Medical Devices | 2015-02-13 |
| BIOS KING BIOCELLULOSE FILM (K141382) | Coreleader Biotech Co., Ltd. | 2015-02-10 |
| Wound Matrix TF (K143426) | Miromatrix Medical, Inc. | 2015-01-27 |
| KA01 Chitosan Wound Dressing (K143124) | Foshan United Medical Technologies, Ltd. | 2015-01-26 |
| Cutimed Sorbact Wound Dressings (Cutimed Sorbact Hydroactive, Cutimed Sorbact Hydroactive B, Cutimed Siltec Sorbact) (K143151) | Bsn Medical GmbH | 2015-01-26 |
| OsteoSeal Bone Hemostat (K142348) | Hemostasis, LLC | 2015-01-23 |
| WOUND DRESSING WITH MANUKA HONEY (K133729) | Manuka Health New Zealand , Ltd. | 2015-01-23 |
| Proficient (TM) Facet Screw Spine System (K142980) | Spine Wave, Inc. | 2015-01-16 |
| DacryoCATH (K142914) | Armadillo Biomedical, LLC | 2015-01-12 |
| NUSTAT, NUSTAT XR (K142363) | Beeken Biomedical | 2015-01-09 |
| Dental Collagen Wound Dressing (Nova Tape and NovaPlug) (K142712) | Novabone Products, LLC | 2015-01-08 |
| HEMASORBPLUS press Resorable Hemostatic Bone Putty (K143069) | Orthocon, Inc. | 2014-12-22 |
| CPX Control Breast Tissue Expander (K142998) | Mentor Worldwide, LLC | 2014-12-19 |
| STOPLOSS JONES TUBE (K140290) | Ljt Surgical, Ltd. | 2014-12-02 |
| Pressure Right, Single-Use, Disposable, Acupressure, Pressure-Sensitive Wrist Strip (K142471) | Pressure Point, Inc. | 2014-12-01 |
| WOUNDCLOT HEMOSTATIC GAUZE (K140573) | Core Scientific , Ltd. | 2014-11-24 |
| VERAPLUG (K140352) | Krishna Imports Inc Dba Stephens Instruments | 2014-11-13 |
| PANTHEON ELECTROSTIMULATOR (K133980) | Pantheon Research | 2014-11-07 |
| SILVERLON ISLAND WOUND DRESSING, SILVERLON WOUND PAD DRESSING (K143001) | Argentum Medical | 2014-11-07 |
| CHLORADERM ANTIMICROBIAL TRANSPARENT THIN FILM DRESSING, 2 3/8 X 2 3/4, 4 X 4 3/4 (K140389) | Entrotech Life Sciences, Inc. | 2014-11-07 |
| CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEM (K141668) | Integra LifeSciences Corporation | 2014-11-06 |
| CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEM (K141674) | Integra LifeSciences Corporation | 2014-11-06 |
| LARVAL DEBRIDEMENT THERAPY PRODUCTS - LARVAE 100/200/300 AND BIOBAG 50/100/200/300/400 (K142020) | Biomonde | 2014-11-05 |
| NAWALUTION SKIN AND WOUND CLEANSER (K141660) | Nawa Heilmittel GmbH | 2014-10-31 |
| ALLOX2 TISSUE EXPANDERS (K140383) | Specialty Surgical Products, Inc. | 2014-10-28 |
| Ultra Silver Dressings (K141603) | Milliken Healthcare Products, LLC | 2014-10-22 |
| DANA (K141865) | Anthrotronix, Inc. | 2014-10-15 |
| HBP4 HARDENING, RESORBABLE HEMOSTATIC BONE PUTTY (K141502) | Orthocon, Inc. | 2014-10-03 |
| Electro Auricular Device (K140530) | Navigant Consulting, Inc. | 2014-10-02 |
| HEMASORB Resorbable Hemostatic Bone Putty (K142339) | Orthocon, LLC | 2014-09-26 |
| ARCHITECT PX EXTRACELLULAR COLLAGEN MATRIX (K140367) | Harbor Medtech, Inc. | 2014-09-12 |
| SILVERLON ISLAND WOUND DRESSING (K141573) | Argentum Medical | 2014-08-28 |
| PREVANTICS DEVICE SWAB (K132380) | Professional Disposables International, Inc. | 2014-08-27 |
| CR3 KEYLESS SPLIT SAMPLE CUP PHENCYCLIDIEN - METHYLENEDIOXYMETHAMPHETAMINE (K142044) | Guangzhou Wondfo Biotech Co., Ltd. | 2014-08-25 |
| IONSIL GEL (K132326) | Virchow Biotech Pvt, Ltd. | 2014-08-21 |
| ENDOCYN ROOT CANAL IRRIGATION SOLUTION (K141352) | Oculus Innovative Sciences | 2014-08-18 |
| HYDROCLEANSE WOUND CARE SOLUTION (K141012) | Oculus Innovative Sciences | 2014-08-08 |
| PREMVIA (K134037) | Biotime, Inc. | 2014-08-07 |
| SONICISION CORDLESS ULTRASONIC DISSECTOR (K141371) | Covidien, Formerly Valleylab, A Division of Tyco H | 2014-08-07 |
| STOPSBLEEDING TOPICAL HEMOSTAT POWDER AND FOAM (K140313) | Coag Medical, LLC | 2014-07-28 |
| EDS COMBO-RINSE (K140846) | Essential Dental Systems, Inc. | 2014-07-25 |
| BIO-CONNEKT WOUND MATRIX (K140456) | MLM Biologics, Inc. | 2014-07-22 |
| D2 HEMOSTANTIC DRESSING (K140757) | Z-Medica, LLC | 2014-07-17 |
| PROCTIGARD (K140558) | Access Pharmaceuticals, Inc. | 2014-07-16 |
| BLOSSOM SALINE DELIVERY ASSIST DEVICE (K131692) | Marz Medical, Inc. | 2014-07-10 |
| FLENTS PLASTIC EYE WASH CUP (K140409) | Apothecary Products, Inc. | 2014-07-09 |
| P-STIM (K140788) | Biegler GmbH | 2014-06-27 |
| BONDILOXS TOPICAL HEMOSTATIC DRESSING (K132333) | Medtrade Products , Ltd. | 2014-06-25 |
| COMFORTEAR LACRISOLVE ABSORBABLE PUNCTUM PLUG, LACRISOLVE ABSORBABLE PUNCTUM PLUG, COMFORTEAR LACRISOLVE PUNCTUM PLUG, (K140711) | Paragon Bioteck, Inc. | 2014-06-20 |
| HYDROLYZED COLLAGEN/AG WOUND GEL WITH SILVER (K132891) | The Hymed Group Corp. | 2014-06-19 |
| MIROMATRIX WOUND MATRIX (K140510) | Miromatrix Medical, Inc. | 2014-06-19 |
| REPROCESSED HARMONIC SHEAR (K132566) | Sterilmed, Inc. | 2014-06-14 |
| AMICUS SEPARATOR SYSTEM/ AMICUS SEPERATOR SYSTEM;REFURBISHED (K141019) | Fenwal, Inc. | 2014-06-10 |