FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
24169–24192 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 14, 2018
Acu-sInQ Complete Endoscope Cleaning Aid System
K181865 · FEB
STERIS Corporation
General Hospital · 155d
Cleared Dec 14, 2018
Phasix ST Mesh with Echo 2 Positioning System
K182008 · FTL
C.R. Bard, Inc.
General & Plastic Surgery · 140d
Cleared Dec 14, 2018
UV Active Implant System
K182194 · DZE
Dio Corporation
Dental · 122d
Cleared Dec 14, 2018
TR90BH
K182207 · IZL
Minxray, Inc.
Radiology · 121d
Cleared Dec 14, 2018
HyperFil-LV
K182296 · EBF
Parkell, Inc.
Dental · 112d
Cleared Dec 14, 2018
SafeAir Telescopic Smoke Pencil
K182354 · GEI
Lina Medical Aps
General & Plastic Surgery · 107d
Cleared Dec 14, 2018
Centricity Universal Viewer
K182419 · LLZ
Ge Healthcare
Radiology · 100d
Cleared Dec 14, 2018
SureClip Repositionable Hemostasis Clip
K182556 · PKL
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 88d
Cleared Dec 14, 2018
Vitrea Software Package, VSTP-001A
K182601 · LLZ
Canon Medical Systems Corporation
Radiology · 84d
Cleared Dec 14, 2018
Rapid Reboot Compression Therapy System
K182668 · IRP
Rapid Reboot Recovery Products, LLC
Physical Medicine · 80d
Cleared CT Dec 14, 2018
AC5 Topical Gel
K182681 · FRO
Arch Therapeutics, Inc.
General & Plastic Surgery · 79d
Cleared Dec 14, 2018
Cardio-TriTest v6.5
K182790 · DPS
Cardio-Phoenix, Inc.
Cardiovascular · 74d
Cleared Dec 14, 2018
RCT800
K182805 · OAS
Ray Co., Ltd.
Radiology · 73d
Cleared Dec 14, 2018
3880 MRI Patient Monitoring System
K182900 · MWI
Iradimed Corporation
Cardiovascular · 59d
Cleared Dec 14, 2018
UniPulse
K182905 · DRL
Seaward Group
Cardiovascular · 59d
Cleared Dec 14, 2018
MTS Omadacycline 0.002-32 µg/mL
K182922 · JWY
Liofilchem S. R. L.
Microbiology · 56d
Cleared Dec 14, 2018
Affixus Hip Fracture Nail
K183162 · HSB
Biomet, Inc.
Orthopedic · 29d
Cleared Dec 13, 2018
BTL-FR2000
K180359 · GEI
BTL Industries, Inc.
General & Plastic Surgery · 307d
Cleared Dec 13, 2018
PYRAMIDION Dental Implants and Prostheses
K180859 · DZE
Dentack Implants, Ltd.
Dental · 255d
Cleared Dec 13, 2018
Accu-Chek Guide Me Blood Glucose Monitoring System
K181131 · NBW
Roche Diabetes Care
Chemistry · 227d
Cleared Dec 13, 2018
Argos
K181372 · DXG
Retia Medical, LLC
Cardiovascular · 204d
Cleared Dec 13, 2018
DuraSheath Introducer Sheath System
K181463 · DYB
Contract Medical International, GmbH
Cardiovascular · 192d
Cleared Dec 13, 2018
CBT Screw Fixation System
K181824 · NKB
U&I Corporation
Orthopedic · 157d
Cleared Dec 13, 2018
ROCCIA® PLIF
K181899 · MAX
Silony Medical GmbH
Orthopedic · 150d