FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
24169–24192 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 11, 2018
SCARLET SRF
K180872 · GEI
VIOL Co., Ltd.
General & Plastic Surgery · 191d
Cleared Oct 11, 2018
NuFACE Trinity
K181008 · NFO
Carol Cole Company Dba Nuface
Neurology · 177d
Cleared Oct 11, 2018
AxSOS 3 Ti
K181091 · HRS
Stryker GmbH
Orthopedic · 170d
Cleared Oct 11, 2018
NeoMatriX Wound Matrix
K181330 · KGN
Nextgen Biologics, Inc.
General & Plastic Surgery · 146d
Cleared Oct 11, 2018
Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe...
K181426 · PNR
Jiangsu Micsafe Medical Technology...
Gastroenterology & Urology · 133d
Cleared Oct 11, 2018
OnePacs System
K181460 · LLZ
Onepacs, LLC
Radiology · 129d
Cleared Oct 11, 2018
Fingertip Pulse Oximeter
K181503 · DQA
Beijing Choice Electronic Technology...
Anesthesiology · 126d
Cleared Oct 11, 2018
Sirona Dental CAD/CAM System
K181520 · NHA
Dentsply Sirona
Dental · 122d
Cleared Oct 11, 2018
DemeTECH PTFE Nonabsorbable Surgical Suture
K181578 · NBY
Demetech Corporation
General & Plastic Surgery · 118d
Cleared Oct 11, 2018
E-CUBE 8
K181617 · IYN
Alpinion Medical Systems Co., Ltd.
Radiology · 114d
Cleared Oct 11, 2018
Piccolo Composite® Plate System
K182015 · HRS
CarboFix Orthopedics , Ltd.
Orthopedic · 76d
Cleared Oct 11, 2018
MONET Anterior Cervical Interbody Fusion Cage System with Supplementary...
K182151 · OVE
Ctl Medical Corporation
Orthopedic · 64d
Cleared Oct 11, 2018
Voyant Electrosurgical Generator
K182244 · GEI
Applied Medical Resources Corp.
General & Plastic Surgery · 52d
Cleared Oct 11, 2018
Ormco Spark Aligner System
K182826 · NXC
Sybron Dental Specialties
Dental · 6d
Cleared Oct 10, 2018
Cellent Spinal Systems
K172826 · NKB
Jiangsu Trauhui Medical Instrument...
Orthopedic · 387d
Cleared Oct 10, 2018
Temperature Probe
K173194 · FLL
Orantech, Inc.
General Hospital · 373d
Cleared Oct 10, 2018
SBG Blue Nitrile Powder Free Medical Examination Glove
K180467 · LZA
Showa Best Glove, Inc.
General Hospital · 231d
Cleared Oct 10, 2018
SBG Black Nitrile Powder Free Medical Examination Glove
K180468 · LZA
Showa Best Glove, Inc.
General Hospital · 231d
Cleared Oct 10, 2018
CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7...
K181038 · PSQ
Cormatrix Cardiovascular, Inc.
Cardiovascular · 174d
Cleared Oct 10, 2018
Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures
K181774 · GAT
Teleflex Medical Incorporated
General & Plastic Surgery · 99d
Cleared Oct 10, 2018
Elvie Pump
K181863 · HGX
Chiaro Technology Limited
Obstetrics & Gynecology · 90d
Cleared Oct 10, 2018
BioHorizons Tapered IM Implants
K182070 · DZE
BioHorizons Implant Systems, Inc.
Dental · 70d
Cleared Oct 10, 2018
Sterile High-pressure Angiographic Syringes for Single-use
K182289 · DXT
Shenzhen Baoan Medical Supplies Co.,...
Cardiovascular · 48d
Cleared Oct 10, 2018
Geminus Volar Distal Radius Plate System
K182492 · HRS
Skeletal Dynamics, LLC
Orthopedic · 29d