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
38449–38472 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 16, 2014
ROTATING ADAPTERS
K140475 · DTL
Merit Medical Systems, Inc.
Cardiovascular · 49d
Cleared Apr 16, 2014
PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM
K140639 · IYN
Hitachi Aloka Medical, Ltd.
Radiology · 35d
Cleared Apr 16, 2014
HUMAN ALPHA2-MACROGLOBULIN KIT FOR USE ON SPAPLUS
K140664 · DEB
The Binding Site Group , Ltd.
Immunology · 29d
Cleared Apr 16, 2014
INSERTION TOOL
K140673 · DQX
Boston Scientific Corp
Cardiovascular · 29d
Cleared Apr 15, 2014
COGENT MED-LIF
K132738 · MAX
Cogent Spine, LLC
Orthopedic · 224d
Cleared Apr 15, 2014
EM40 SELF-MONITORING BLOOD GLUCOSE SYSTEM
K133389 · NBW
Eps Bio Technology Corp.
Chemistry · 161d
Cleared Apr 15, 2014
6200 / 6250 ULTRASOUND SYSTEM
K133905 · IYN
Esaote, S.P.A.
Radiology · 113d
Cleared Apr 15, 2014
FLEXIVA SF SIDE-FIRING SINGLE-USE LASER FIBER
K140503 · GEX
Boston Scientific
General & Plastic Surgery · 47d
Cleared Apr 15, 2014
MAXZERO EXTENSION SET WITH NEEDLESS CONNECTOR
K140831 · FPA
Care Fusion
General Hospital · 13d
Cleared Apr 14, 2014
DISCOSCOPES, CERVICAL ENDOSCOPES
K130778 · HRX
Rz Medizintechnik GmbH
Orthopedic · 389d
Cleared Apr 14, 2014
AVANCE® FOAM ABDOMINAL DRESSING KIT
K130852 · OXJ
Molnlycke Health Care
General & Plastic Surgery · 382d
Cleared Apr 14, 2014
MYHEALTHPOINT TELEHEALTH MANAGER
K132930 · DRG
Entra Health Systems
Cardiovascular · 208d
Cleared CT Apr 14, 2014
ERCHONIA ALLAY
K132940 · NHN
Erchonia Medical, Inc.
Physical Medicine · 207d
Cleared Apr 14, 2014
CERVICAL STAND ALONE SYSTEM
K132999 · OVE
Orthofix, Inc.
Orthopedic · 202d
Cleared Apr 14, 2014
DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE
K133957 · BYE
Galemed Corp.
Anesthesiology · 112d
Cleared CT Apr 14, 2014
CABOCHON SYSTEM
K134010 · OUP
Cabochon Aesthetics, Inc.
General & Plastic Surgery · 105d
Cleared Apr 14, 2014
ELISIO-H HEMODIALYZER
K140191 · KDI
Nipro Medical Corporation
Gastroenterology & Urology · 77d
Cleared Apr 14, 2014
NAMIC RCS SYRINGE
K140194 · FMF
Navilyst Medical, Inc.
General Hospital · 77d
Cleared Apr 14, 2014
PICASSO II MIS SPINAL SYSTEM
K140219 · NKB
Accel Spine
Orthopedic · 75d
Cleared Apr 11, 2014
POWDERED VINYL EXAMINATION GLOVES
K122176 · LYZ
Shu Tong Xinghua Co., Ltd.
General Hospital · 627d
Cleared Apr 11, 2014
POWDER FREE VINYL EXAMINATION GLOVES
K122377 · LYZ
Shu Tong Xinghua Co., Ltd.
General Hospital · 627d
Cleared Apr 11, 2014
ALL-BOND UNIVERSAL SC (NOT FINALIZED)
K131734 · KLE
Bisco, Inc.
Dental · 302d
Cleared Apr 11, 2014
AUDICOR CPAM WITH SDB (ACCELEROMETER BASED)
K131883 · MNR
Inovise Medical, Inc.
Anesthesiology · 290d
Cleared Apr 11, 2014
SCANWAVE PEN (WITH LIGHT GRAY CORD), SCANWAVE PEN (WITH MEDIUM GRAY CORD),...
K131906 · EBZ
Satelec - Acteon Group
Dental · 289d