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
7105–7128 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 16, 2024
HD80 Series Ultrasound Diagnostic System
K233841 · IYN
Qingdao Hisense Medical Equipment...
Radiology · 164d
Cleared May 16, 2024
RAYDENT SW
K233625 · PNN
Ray Co., Ltd.
Dental · 185d
Cleared May 16, 2024
DEKA LOTUS
K233473 · ONF
El.En S.P.A.
General & Plastic Surgery · 204d
Cleared May 16, 2024
Ticare Dental Implant Systems
K233137 · DZE
Mozograu S.A.
Dental · 232d
Cleared May 16, 2024
AirKEE P900
K232933 · FRA
Healkee Medical Pte, Ltd.
General Hospital · 239d
Cleared May 16, 2024
Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer...
K232849 · FYC
Owens & Minor (O&M) Halyard, Inc.
General Hospital · 245d
Cleared May 16, 2024
Stimulation System (PA series, PR series, S series and Q series)
K232786 · IPF
Edan Instruments, Inc.
Physical Medicine · 248d
Cleared May 16, 2024
Wedge XL Delivery Catheter
K232542 · QJP
MicroVention, Inc.
Neurology · 268d
Cleared May 16, 2024
Sempulse Halo Vital Signs Monitor
K232495 · DQA
Sempulse Corporation
Anesthesiology · 273d
Cleared May 16, 2024
Pain Therapy Device(Model: P.T.S-X)
K230711 · NGX
Guangzhou Xinbo Electronic Co., Ltd.
Physical Medicine · 428d
Cleared May 15, 2024
BriefCase-Quantification
K241112 · QIH
Aidoc Medical , Ltd.
Radiology · 23d
Cleared May 15, 2024
MVR™ Venous Reservoir Bag 800 mL
K241053 · DTN
Medtronic Cardiac Surgery
Cardiovascular · 28d
Cleared May 15, 2024
CANON Fundus Camera CR-10 (CR-10)
K241049 · HKI
Canon, Inc.
Ophthalmic · 28d
Cleared May 15, 2024
Augment Off-Axis Instrument System
K241043 · PHX
Fix Surgical
Orthopedic · 28d
Cleared May 15, 2024
E3D™-A Interbody System
K240368 · OVD
Evolution Spine
Orthopedic · 99d
Cleared May 15, 2024
Full Wedge Lateralized and Augmented Baseplates
K240278 · PHX
Fx Shoulder USA, Inc.
Orthopedic · 104d
Cleared May 15, 2024
TRIUX™ neo (NM27000N )
K233985 · OLX
Megin OY
Neurology · 149d
Cleared May 15, 2024
Heuron ICH
K233247 · QAS
Heuron Co., Ltd.
Radiology · 230d
Cleared May 15, 2024
BruxZir® NOW SRC
K231940 · NHA
Prismatik Dentalcraft, Inc.
Dental · 320d
Cleared May 14, 2024
Aventus Clot Management System
K240426 · CAC
Inquis Medical
Cardiovascular · 91d
Cleared May 14, 2024
Electric Breast Pump (BRP-301)
K233913 · HGX
Aoj Health Technology Co., Ltd.
Obstetrics & Gynecology · 154d
Cleared May 14, 2024
BNLE Hydrophilic Jacketed Peripheral Guidewire
K232662 · DQX
Biomerics Nle
Cardiovascular · 257d
Cleared May 13, 2024
Healgen® Accurate Fentanyl Rapid Test Cassette (Urine)
K240949 · NGL
Healgen Scientific, LLC
Toxicology · 35d
Cleared May 13, 2024
REMEX-GR100
K240759 · EHD
Remedi Co., Ltd.
Radiology · 54d