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

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RecordFirmDate
MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty (K220315)Orthocon, Inc.2022-03-11
Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets (K211911)Coloplast Corp.2022-03-10
Oclet TDS 1000 (K212049)Tendonova Corporation2022-03-08
Ion Facet Screw System (K211855)SurGenTec, LLC2022-02-25
PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large Dressing (K210135)3M Healthcare Business Group2022-02-24
Glidewell Appliance Resin, Hard/Soft (K214102)Prismatik Dentalcraft, Inc.2022-02-23
Zeolite Hemostatic Gauze (K211570)Hangzhou Zeo-Innov Life Technology Co., Ltd.2022-02-10
PELNAC Wound Matrix (K213573)Gunze Limited2022-02-09
Sonopet iQ Ultrasonic Aspirator System (K213824)Stryker Corporation2022-02-03
Silver Gelling Fiber Dressing (K210466)Winner Medical Co., Ltd.2022-01-14
Ora-Aid (K211851)Tbm Corporation2022-01-11
Gingi-Aid Gel (K211419)Belport Company, Inc., Gingi-Pak2022-01-10
SleepRight Select-Comfort Dental Guard (K212767)Splintek, Inc.2021-12-22
Cellusheet, Cellufil (K213092)Human Biosciences, Inc.2021-12-15
neXus Ultrasonic Surgical Aspirator System (K212060)Misonix, Inc.2021-12-13
SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard (K212706)Splintek, Inc.2021-12-13
VOCO Retraction Paste (K213149)Voco GmbH2021-12-09
Independent Corneal Viewing Chamber (IVC-21) (K211786)Bausch + Lomb, Incorporated2021-12-03
Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection Device (K212301)Covidien, LLC2021-11-15
NightGuard Flex (K212448)Sprintray, Inc.2021-11-12
TraumaGuard Intra-abdominal Pressure Sensing System (K210570)Sentinel Medical Technologies, LLC2021-10-29
GR Splint Resin System (K211415)Pro3Dure Medical GmbH2021-10-21
EQ-PEX (K210789)Meta Systems Co., Ltd.2021-10-20
Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use) (K202982)Winner Medical Co., Ltd.2021-10-19
INTEGRA Wound Matrix (Macro-Channels) (K210128)Integra LifeSciences Corporation2021-10-08
PuraStat-OM (K210211)3-D Matrix, Inc.2021-10-08
NeoMatriX Wound Matrix (K210024)Nextgen Biologics, Inc.2021-10-07
Ultrasonic Surgical Aspirator System, Model: XD880B (K212750)Smtp Technology Co., Ltd.2021-09-27
TorrentX Wound Wash (K203446)Next Science, LLC2021-09-23
NTI ClenchGuard (K211158)Boyd Research, Inc.2021-09-17
EPIEN Dental Cleanser (K201785)Epien Medical, Inc.2021-09-09
LuxaPrint Ortho Plus (K210940)Dmg Digital Enterprises SE2021-09-03
Dentilube Spray (K202689)Oxy2plus, LLC2021-09-03
Omeza Collagen Matrix (K211972)Omeza, LLC2021-09-01
Bonine Acupressure Bands (K211823)Wellspring Pharmaceutical Corporation2021-09-01
Needle Stimulator (K202861)Wuxi Jiajian Medical Instrument Co., Ltd.2021-08-27
Triton (K211813)Inter-Med / Vista Dental2021-08-18
Ultrasonic Bipolar Generator USG-410 with accessories (K211838)Olympus Medical Systems Corporation2021-08-04
JS Dental Lab Mouth Guard (K210011)Ampower Dental Laboratories, LLC2021-07-16
TMJ Relax (K202523)Moonwalker Innovations, Inc.2021-06-24
NATRELLE INSPIRA Single Use Sizers for Gel Implants (K203229)Allergan2021-06-02
Harmonic Hand Piece, Blue, Harmonic Hand Piece, Gray (K211273)Ethicon Endo-Surgery, LLC2021-05-21
Ultrasonic Surgical Aspirator System (K202299)Smtp Technology Co., Ltd.2021-05-21
High Performance Antimicrobial Gelling Fiber with Silver (K210974)Advanced Medical Solutions, Ltd.2021-05-12
MIS Solution (K203835)Next Science, LLC2021-04-23
MY01 Continuous Compartmental Pressure Monitor (K210525)MY01, Inc.2021-04-22
InnovaMatrix FS (K210580)Triad Life Sciences, Inc.2021-04-21
SEFRIA PCP Oral Fluid Enzyme Immunoassay (K203489)Immunalysis Corporation2021-04-20
Panthera Occlusal Appliance (K203596)Panthera Dental, Inc.2021-04-20
Axiostat Patch (K202830)Advamedica, Inc.2021-04-15
AMSure® Single Use Saline Topical Solution (K201138)Amsino Medical, Inc.2021-04-14
KeyPrint KeySplint Hard (K203000)Mycone Dental Supply Co. Inc. (Dba Keystone Industries)2021-04-09
Oral-B Dry Mouth Oral Rinse (K203567)The Procter & Gamble Company2021-04-05
Myriad Particles (K200502)Aroa Biosurgery , Ltd.2021-03-31
BOMEDENT Apex locator, WISMY Apex locator (K203836)Changzhou Bomedent Medical Technology Co.,Ltd2021-03-30
Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced Hemostasis (K202554)Stryker Sustainability Solutions2021-03-16
Ritleng®+ and Ritleng®+ PVP (K201892)Fci (France Chirurgie Instrumentation) Sas2021-03-11
Eustachi Ear Pressure Relief Device (K203754)Exercore, LLC2021-02-19
MucoLock Oral Gel (K203091)Pcca, Inc.2021-02-12
Antibacterial Bandage (K201324)Jiangsu Excellence Medical Supplies Co., Ltd.2021-02-05
AXUS ES-5 Electro-Acupuncture Device (K200636)Lhasa Oms, Inc.2021-02-03
LUOFUCON PHMB Alginate Dressing (Rx use), LUOFUCON PHMB Antibacterial Alginate Wound Dressing (OTC use) (K201016)Huizhou Foryou Medical Devices Co., Ltd.2021-01-28
HBP7 Settable Hemostatic Bone Putty (K202363)Orthocon, Inc.2021-01-19
Ava Fertility Tracker (K200163)Ava AG2021-01-19
MatriDerm (K201577)Medskin Solutions Dr. Suwelack AG2021-01-07
DenTek Fresh Protect Dental Guard (K202974)Medtech Products, Inc.2020-12-22
num Vapocoolant (K202782)623 Medical, LLC2020-12-21
LacriJet® (K201606)Fci (France Chirurgie Instrumentation) Sas2020-12-18
In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath (K201165)Coloplast Corp.2020-12-17
MY01 Continuous Compartmental Pressure Monitor (K202635)MY01, Inc.2020-12-10
E-Guard (K201173)Envisiontec GmbH2020-11-27
Night Guard (K202465)3D Diagnostix, Inc.2020-11-25
Silatrix Oral Gel (K202000)Sa3, LLC2020-11-20
Sientra OPUS Silicone Gel Breast Implant Sizer (K200706)Sientra, Inc.2020-11-16
V-Print splint (K201091)Voco GmbH2020-11-06
Thermoforming Sheet Materials (K200125)Erkodent Erich Kopp GmbH2020-10-28
V-Mix (K193357)Inter-Med/Vista Dental Products2020-10-23
InnovaMatrix (K193552)Triad Life Sciences, Inc.2020-10-21
anti-bacterial bandage (K200821)Planet (Suzhou) Medical Products Co., Ltd.2020-10-19
STATSTIX (K200764)Centrix Incorporated2020-10-15
SilverStream Gel (K200767)Enzysurge , Ltd.2020-10-08
Restrata® (K193583)Acera Surgical, Inc.2020-09-25
Vista Rinse, Vista Rinse Plus (K193409)Inter-Med/Vista Dental Products2020-09-09
MEBO Wound Dressing (K193439)Mebo Life Science, Inc.2020-09-04
3M Tegaderm CHG Chlorhexidine Gluconate Gel Pad (K200835)3M Company2020-09-04
HaloGUARD Protective Disc with CHG (K200641)Attwill Medical Solutions2020-09-03
Oral-B Dry Mouth Oral Rinse (K201277)The Procter & Gamble Company2020-09-02
Hemostatic Xerogel Sponge (K192671)Solaplus Biotech Co., Ltd.2020-08-28
Medline ReNewal Reprocessed Harmonic ACE+7 Shears (K193563)Surgical Instrument Service and Savings Inc.(Dba Medline Ren2020-08-19
RadGil2 (K201177)R3 X-Ray L.L.C2020-08-17
Syringe Holder accessory (K201248)Vapocoolshot, Inc.2020-08-12
Orion (K200529)Interacoustics A/S2020-08-12
MY01 Continuous Compartmental Pressure Monitor (K193321)MY01, Inc.2020-07-30
Symphony (K200413)Aroa Biosurgery , Ltd.2020-07-29
KeraStat Cream (K192386)Keranetics2020-07-16
Sonicision Cordless Ultrasonic Dissector (K200427)Covidien, LLC2020-07-10
RC-Prime Root Canal Preparation Cream (K200330)Pac-Dent, Inc.2020-07-06
D-Stat Radial Topical Hemostat (K200720)Vascular Solutions, LLC2020-06-26
CUSA Clarity Ultrasonic Surgical Aspirator System (K200774)Integra LifeSciences Corporation2020-06-23
Kogent Torus Ultrasonic Aspirator (K192963)Katalyst Surgical, LLC2020-06-19
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