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3,051 FDA 510(k) clearances · Device class

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RecordFirmDate
Caphosol Artifical Saliva Tablets (K162167)Eusa Pharma (Uk) Limited2017-03-31
LUOFUCON Silicone Ag Foam Dressing with Border (K170077)Huizhou Foryou Medical Devices Co., Ltd.2017-03-30
ReliaTect Post-Op Dressing with CHG (8cm x 15cm), ReliaTect Post-Op Dressing with CHG (10cm x 25cm) (K163529)Avery Dennison Corporation2017-03-29
LOYON (K162217)Oculus Innovative Sciences2017-03-23
ANSiStim-PP (K170391)Dyansys, Inc.2017-03-09
Straumann PrefGel (K162311)Institut Straumann AG2017-03-07
Next Science Wound Gel (Rx) (K163188)Next Science, LLC2017-03-06
Curasite (K161991)Izun Pharmaceuticals2017-03-03
Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced Hemostasis (K161693)Stryker Sustainability Solutions2017-02-23
ALLY™ Facet Screws (K163374)Providence Medical Technology, Inc.2017-02-16
KerraCel Ag Gelling Fiber Silver Dressing (K162508)Exciton Technologies, Inc.2017-02-13
GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction Cord (K162536)Kerr Corporation2017-02-03
Bondiloxs Topical Hemostatic Granules (K161274)Medtrade Products , Ltd.2017-01-18
GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord (K162164)Kerr Corporation2017-01-13
Talymed Suspension (K160695)Marine Polymer Technologies, Inc.2016-12-06
HEMASORBPLUS Resorbable Hemostatic Bone Putty (K153317)Orthocon, Inc.2016-11-30
InnoSEAL Hemostatic Pad (K161013)Innotherapy, Inc.2016-11-29
PolyPlex Wound Dressing (K160872)Global Health Solutions, LLC2016-11-23
Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102 (K162218)Nuance Medical, LLC2016-11-22
LacriPro Punctum Plug (K161673)Lacrimedics, Inc.2016-11-18
Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solution, 1000 mL (K161623)B.Braun Medical, Inc.2016-11-10
VSTAAR AdjusteR (K160278)Spinal Acoustics, LLC2016-11-04
Nunchaku (K161373)Fci (France Chirurgie Instrumentation)2016-11-03
Unger Quad Injector (K161483)Stradis Healthcare2016-10-31
Xonrid Gel (K152533)Helsinn Healthcare SA2016-10-28
CUSA Clarity Ultrasonic Surgical Aspirator System (K161882)Integra LifeSciences Corporation2016-10-14
Dynarex Xeroform Petrolatum Dressing (K152970)Dynarex Corporation2016-10-03
Atteris Antimicrobial Skin Protectant (K161212)Rochal Industries, LLC2016-09-30
Flowable Wound Matrix (K160136)Cook Biotech Incorporated2016-09-28
DONASORB SILVER WOUND DRESSING (K153565)Virchow Biotech Pvt, Ltd.2016-09-22
Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen Advanced Wound Matrix, 1x6” (K161067)Engineered Tissue Solutions, LLC2016-09-15
Eusol-C (K162013)Al.Chi.Mi.A. S.R.L2016-09-15
ACTICOAT Surgical Dressing (K153723)Smith & Nephew Medical Limited2016-09-14
Anexa Wound Flush, Sterile Water & Sterile Normal Saline (K161658)Anexa Biomedical, Inc.2016-09-14
Procellera (K160783)Vomaris Innovations, Inc.2016-09-07
USP Sterile Water, 120 mL cup, USP Sterile Normal Saline (0.9% sodium chloride), 120 mL cup, USP Sterile Water, 100 mL,250 mL and 500 mL bottles, USP Sterile Normal Saline (0.9% sodium chloride), 100 mL, 250 mL and 500 mL bottles (K161311)Strukmyer Medical, LLC2016-08-29
Exufiber Ag+ (K160379)Molnlycke Health Care Us, LLC2016-08-25
Microcyn Plus Wound Care Solution (K161034)Oculus Innovative Sciences2016-08-19
LUOFUCON Silicone Ag foam dressing (K160022)Huizhou Foryou Medical Devices Co., Ltd.2016-08-17
Raycell Mk2 (K161324)Best Theratronics Limited2016-08-12
WoundClot9 (K160679)Core Scientific Creation , Ltd.2016-08-08
PermeaDerm B, PermeaDerm CW, and PermeaDerm Glove (K153678)Permeaderm, Inc.2016-08-08
Microlyte Ag (K153756)Imbed Biosciences, Inc.2016-08-04
FacetBRIDGE® System (K161798)Ldr Spine USA, Inc.2016-08-04
DURAFIBER Ag (K161289)Smith & Nephew Medical Limited2016-08-03
The Luco Hybrid OSA Appliance (K160477)Luco Hybrid Osa Appliance, Inc.2016-07-29
Atteris Antimicrobial Skin & Wound Cleanser (K160192)Rochal Industries, LLC2016-07-28
PacEndo Chlorhexidine (K160577)Pac-Dent International, Inc.2016-07-25
Dakin's Skin and Wound Cleanser (K150208)Century Pharmaceuticals, Inc.2016-07-21
RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set (K160077)Jbw7 Innovations, LLC2016-07-12
Sorbact Foam Gentle Border, Sorbact Superabsorbent (K153674)Abigo Medical AB2016-07-01
BloodSTOP iX Battle Matrix (K160130)Lifescience Plus, Inc.2016-06-29
HARMONIC HD 1000i Shears 20 cm Length, HARMONIC HD 1000i Shears 36 cm Length (K160752)Ethicon Endo-Suregery, LLC2016-06-29
Nustat XR (K160578)Beeken Biomedical, LLC2016-06-29
Collagen Dental Wound Dressings (K152600)Collagen Matrix, Inc.2016-06-23
Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science Antimicrobial Wound & Skin Cleanser 8oz, Simple Science Antimicrobial Wound & Skin Cleanser 16oz, Simple Science Antimicrobial Wound & Skin Cleanser 23oz (K160095)Simple Science, LLC2016-06-10
MTR550 (Tentative) Antimicrobial Silver Wound Gel (K152519)Medical Technology Research, Inc.2016-06-02
Stivax (K152571)Biegler GmbH2016-05-26
Prometheus ChitoGauze XR PRO (K153582)Hem Con Medical Technologies, Inc.2016-05-25
Agem Ag Mesh Dressing with Silver (K152544)Shenzhen Yuanxing Nano-Pharma Co., Ltd.2016-05-23
ARTOURA Breast Tissue Expanders with Smooth Surface (K161176)Mentor Worldwide, LLC2016-05-23
Oasis Lacrimal Intubation Set (K160710)Anodyne2016-05-13
Dash-Topic Plus Cream (K150914)Founders Science Group, LLC2016-04-21
Microcyn Plus Skin and Wound Hydrogel (K153648)Oculus Innovative Sciences2016-04-19
Nutraseb Facial Cream (K143605)Isdin Corp.2016-04-14
Sonicision Cordless Ultrasonic Dissection Device (K153371)Covidien, LLC2016-03-28
QbCheck (K143468)Qbtech AB2016-03-22
MicroMatrix (K153754)Acell, Inc.2016-03-14
HARMONIC HOOK (K151136)Ethicon Endo-Surgery, LLC2016-03-04
Tenex Health TX System (K153299)Tenex Health, Inc.2016-03-03
PriMatrix Dermal Repair Scaffold (K153690)Tei Biosciences, Inc.2016-02-22
CPX 4 Breast Tissue Expander (K152496)Mentor Worldwide, LLC2016-02-19
Ora-GUARD Dental Grind Guard (K150492)Bite Tech, Inc.2016-02-19
ROP Resorbable Hemostasis Material (K153095)Resorbable Orthopedic Products, LLC2016-02-17
AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser (Rx) and AGX Wound Wash Skin and Wound Cleanser (OTC) (K151185)Abl Medical, LLC2016-02-05
Dr's Finder (K151274)Good Doctors Co., Ltd.2016-02-04
PacEndo EDTA (K153528)Pac-Dent International, Inc.2016-02-01
Medline ReNewal Reprocessed Harmonic ACE + Shears without Adaptive Tissue Technology (K151405)Surgical Instrument Services and Savings(Dba Medline Renewal2016-01-26
FacetBRIDGE System (K152137)Ldr Spine USA2016-01-25
AQUACEL Ag Surgical SP Dressing (K152926)Convatec Limited2016-01-21
Spectra Optia Apheresis System (K153601)Terumobct, Inc.2016-01-14
MedActive Oral Gel and Spray (K152201)Medactive Oral Pharmaceuticals, LLC2015-12-30
SalivaMAX (K152406)Forward Science, LLC2015-12-23
L-Mesitran Dressing Family II- Soft and Tulle (K150676)Theo Manufacturing BV2015-12-23
BTM Wound Dressing (K142879)Polynovo Biomaterials Pty, Ltd.2015-12-23
Nexodyn AOS Wound Care Solution (K151168)Apr Applied Pharma Research SA2015-12-22
CUSA Excel+ (K150682)Integra Lifesciences Corp.2015-12-18
Next Science Wound Gel (K150792)Next Science, LLC2015-12-17
Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue Technology (K150524)Surgical Instrument Services and Savings, Inc.2015-12-16
Alevicyn SG Antipruritic Gel (K152945)Oculus Innovative Sciences2015-12-15
BRX PRO Bruxism Guard (K151933)12th Man Technologies, Inc.2015-12-10
Cytal Wound Matrix (K152721)Acell, Inc.2015-12-08
Stay Fresh Hydrocolloid dressing (K151186)Sarasota Medical Products, Inc.2015-11-27
Ceramax Skin Barrier Cream (K152055)Oculus Innovative Sciences2015-11-23
Puracyn(R) Plus Duo-Care(TM) Antimicrobial Wound & Skin Hydrogel, Puracyn(R) Plus Antimicrobial Hydrogel Professional Formula (K150799)Innovacyn, Inc.2015-11-19
Medihoney Wound Gel (K150985)Derma Sciences, Inc.2015-11-19
HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid PRO, ChitoFlex PRO (K150916)Hem Con Medical Technologies, Inc.2015-11-10
PacEndo Sodium Hyprochlorite (K151852)Pac-Dent International, Inc.2015-11-10
AnsCare ChitoClot Pad (K150963)Benq Materials Corporation2015-11-05
BD ChloraShield IV Dressing with CHG Antimicrobial (K152923)Avery Dennison Belgie Bvba2015-11-05
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