Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

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

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175,820 results
31225–31248 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 01, 2016
BC-5D Hematology Control
K160606 · JPK
R&D Systems, Inc.
Hematology · 183d
Cleared Sep 01, 2016
EzRay Air (Model VEX-P300)
K161063 · EHD
VATECH Co., Ltd.
Radiology · 139d
Cleared Sep 01, 2016
MTA2.2 MATERIAL
K161239 · KIF
Avalon Biomed, Inc.
Dental · 122d
Cleared Sep 01, 2016
Sysmex Automated Blood Coagulation Analyzer CS-2100i
K161312 · JPA
Siemens Healthcare Diagnostics...
Hematology · 114d
Cleared Sep 01, 2016
EMG Pink Nitrile Examination Glove Powder Free
K161320 · LZA
Eco Medi Glove Sdn. Bhd.
General Hospital · 113d
Cleared Sep 01, 2016
Elation Pulmonary Balloon Dilation
K161392 · KTI
Merit Medical Systems, Inc.
Ear, Nose, Throat · 105d
Cleared Sep 01, 2016
DUO
K161565 · ONF
Stetic Medical Aesthetics Development...
General & Plastic Surgery · 87d
Cleared Sep 01, 2016
SIGNA Voyager
K161567 · LNH
Ge Healthcare
Radiology · 86d
Cleared Sep 01, 2016
Ambu aScope 3 Regular 5.0/2.2, Ambu aScope 3 Slim 3.8/1.2, Ambu aScope 3...
K161656 · EOQ
Ambu A/S
Ear, Nose, Throat · 77d
Cleared Sep 01, 2016
Madsen Zodiac
K161707 · ETY
Gn Otometrics
Ear, Nose, Throat · 72d
Cleared Sep 01, 2016
XP202
K161922 · EIH
3M Deutschland GmbH
Dental · 50d
Cleared Sep 01, 2016
PerkinElmer, XRpad2 3025 HWC-M Flat Panel Detector
K161942 · MQB
Perkinelmer, Inc.
Radiology · 48d
Cleared Sep 01, 2016
Monoject Enteral Syringe with ENFit Connector
K161963 · PNR
Covidien
Gastroenterology & Urology · 45d
Cleared Sep 01, 2016
CareView 1500P X-ray Flat Panel Detectors
K162178 · MQB
Careray Digital Medical System Co., Ltd.
Radiology · 28d
Cleared Aug 31, 2016
MTA Repair HP
K151047 · KIF
Angelus Industria DE Productos...
Dental · 499d
Cleared Aug 31, 2016
Exactech® Novation® Element Press-fit Femoral Stem
K153649 · MEH
Exactech, Inc.
Orthopedic · 254d
Cleared Aug 31, 2016
ACCU-CHEK Guide Blood Glucose Monitoring System
K160944 · NBW
Roche Diabetes Care, Inc.
Chemistry · 148d
Cleared Aug 31, 2016
HydroCoil Embolic System (HES)
K161367 · HCG
MicroVention, Inc.
Neurology · 106d
Cleared CT Aug 31, 2016
MAGiC
K161397 · LNH
Ge Medical Systems, LLC
Radiology · 104d
Cleared Aug 31, 2016
MicroPlex Coil System (MCS) - HyperSoft 3D
K161452 · HCG
MicroVention, Inc.
Neurology · 97d
Cleared CT Aug 31, 2016
Trojan Chain Reaction Personal Lubricant
K161544 · NUC
Church & Dwight Co., Inc.
Obstetrics & Gynecology · 89d
Cleared Aug 31, 2016
Vscan Extend
K161588 · IYN
GE Medical Systems Ultrasound &...
Radiology · 84d
Cleared Aug 31, 2016
1.5T and 3.0T 16 CH GE Shoulder Coils
K162001 · MOS
Invivo Corporation
Radiology · 42d
Cleared Aug 31, 2016
RENASYS-G Gauze Dressing Kits with Soft Port
K162129 · OMP
Smith & Nephew, Inc.
General & Plastic Surgery · 30d