FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
2497–2520 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 24, 2025
ROBOPERA (ER-R-002)
K244029 · FDF
Endorobotics Co., Ltd.
Gastroenterology & Urology · 268d
Cleared Sep 24, 2025
Retraxil
K243910 · MVL
Kulzer, LLC
Dental · 279d
Cleared Sep 23, 2025
Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1)
K253053 · EBF
Hangzhou SHINING3D Dental Technology...
Dental · 1d
Cleared Sep 23, 2025
PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture
K252644 · NEW
M/s. Meril Endo Surgery Private Limited.
General & Plastic Surgery · 33d
Cleared Sep 23, 2025
Ion Endoluminal System (IF1000)
K252045 · EOQ
Intuitive Surgical, Inc.
Ear, Nose, Throat · 85d
Cleared Sep 23, 2025
Bipolar applicator CelonProBreath (WB990310)
K252043 · GEI
Olympus Winter & Ibe GmbH
Ear, Nose, Throat · 85d
Cleared Sep 23, 2025
Rapid Aortic Measurements
K251987 · QIH
Ischemaview, Inc.
Radiology · 88d
Cleared Sep 23, 2025
Edwards MC3 Tricuspid annuloplasty ring (4900)
K251982 · KRH
Edwards Lifesciences, LLC
Cardiovascular · 88d
Cleared Sep 23, 2025
Luminance Red Cold Sore Device (TN1927G)
K251973 · OKJ
Luminance Medical Ventures, Inc.
General & Plastic Surgery · 89d
Cleared Sep 23, 2025
Himaging Bronchscope System
K251894 · EOQ
Himaging Technology (Shanghai) Co., Ltd.
Ear, Nose, Throat · 95d
Cleared Sep 23, 2025
SwiftSight-Brain
K251483 · QIH
Airs Medical, Inc.
Radiology · 132d
Cleared Sep 23, 2025
Zenflow Spring Scope
K251140 · FAJ
Zenflow, Inc.
Gastroenterology & Urology · 162d
Cleared Sep 23, 2025
Polyvinyl Alcohol Embolic Microspheres
K250209 · KRD
Canyon Medical, Inc.
Obstetrics & Gynecology · 242d
Cleared Sep 22, 2025
Santreva™-ATK Endovascular Revasculariztion Catheter
K252315 · PDU
AngioSafe, Inc.
Cardiovascular · 59d
Cleared Sep 22, 2025
SPI LaproSac™ Laparoscopic Single-Use Rip-Stop Nylon Specimen Retrieval System
K251743 · GCJ
Surgical Principals, Inc.
General & Plastic Surgery · 108d
Cleared Sep 22, 2025
ENDOFLATOR +
K250388 · HIF
Karl Storz SE & CO. KG
Obstetrics & Gynecology · 223d
Cleared Sep 22, 2025
Babio® Virus Transport Kit (Non-inactivating)
K250205 · JSM
Jinan Babio Biotechnology Co., Ltd.
Microbiology · 241d
Cleared Sep 22, 2025
IC-Flow™ Imaging System 2.0
K243645 · IZI
Diagnostic Green GmbH
General & Plastic Surgery · 300d
Cleared Sep 19, 2025
UniBur
K252662 · HBE
Nakanishi, Inc.
Neurology · 28d
Cleared Sep 19, 2025
Impact PEEK Union Nail System
K252657 · HTY
Nvision Biomedical Technologies, Inc.
Orthopedic · 28d
Cleared Sep 19, 2025
Tapestry Biointegrative Implant
K252647 · OWY
Embody, Inc.
Orthopedic · 29d
Cleared Sep 19, 2025
Unscented menstrual three-piece applicator tampon
K252613 · HEB
Unibeauty (Hubei) Technology Co., Ltd.
Obstetrics & Gynecology · 31d
Cleared Sep 19, 2025
Well-Root PT
K252285 · KIF
Vericom Co., Ltd.
Dental · 58d
Cleared Sep 19, 2025
EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V)
K251867 · FDT
Olympus Medical Systems Corp.
Gastroenterology & Urology · 94d