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
40609–40632 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 08, 2013
OSSEUS BLACK DIAMOND PEDICLE SCREW SYSTEM
K131810 · MNH
Osseus Fusion Systems, LLC
Orthopedic · 50d
Cleared Aug 08, 2013
PTS-X SIZING BALLOON CATHETER
K131869 · MJN
NuMED, Inc.
Cardiovascular · 45d
Cleared Aug 08, 2013
GE DATEX-OHMEDA AVANCE CS2
K131945 · BSZ
Datex-Ohmeda
Anesthesiology · 42d
Cleared Aug 08, 2013
BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND...
K132090 · DLJ
Randox Laboratories, Ltd.
Toxicology · 27d
Cleared Aug 07, 2013
PROTHELIAL
K123904 · FRO
Mueller Medical International, LLC
General & Plastic Surgery · 231d
Cleared Aug 07, 2013
FOREIGN BODY HOOD
K130148 · FDS
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 197d
Cleared Aug 07, 2013
QUADCUT
K130608 · HAW
Medtronic Navigation, Inc.
Neurology · 153d
Cleared Aug 07, 2013
FIREBIRD SPINAL FIXATION SYSTEM
K130932 · NKB
Orthofix, Inc.
Orthopedic · 125d
Cleared Aug 07, 2013
ACTIVE BREATHING COORDINATOR
K131313 · IYE
Aktina Medical Corp.
Radiology · 92d
Cleared Aug 07, 2013
TIARRAY DENTAL IMPLANT SYSTEM
K131345 · DZE
Nasseo, Inc.
Dental · 90d
Cleared Aug 07, 2013
INTEGRA TITANIUM BONE WEDGE
K131360 · HRS
Ascension Orthopedic
Orthopedic · 86d
Cleared Aug 07, 2013
KATIA SYSTEM
K131512 · KWQ
Shanghai Sanyou Medical Co, Ltd.
Orthopedic · 71d
Cleared Aug 07, 2013
RSH BILIARY STONE REMOVAL DEVICE
K131642 · LQR
Rsh, LLC
Gastroenterology & Urology · 64d
Cleared Aug 07, 2013
I.T.S. EXTREMITY FIXATION SYSTEMS
K131722 · HRS
I.T.S. GmbH
Orthopedic · 56d
Cleared Aug 07, 2013
BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B
K132256 · PSZ
Becton, Dickinson and Company
Microbiology · 19d
Cleared Aug 07, 2013
BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B
K132259 · PSZ
Becton, Dickinson and Company
Microbiology · 19d
Cleared Aug 06, 2013
OVUSENSE
K122337 · LHD
Fertility Focus, Ltd.
Obstetrics & Gynecology · 369d
Cleared Aug 06, 2013
BRACCO DIAGNOSTICS INC. CO2 ENDOSCOPIC INSUFFLATOR IN LINE TUBING SET
K123047 · FCX
Bracco Diagnostic, Inc.
Gastroenterology & Urology · 312d
Cleared Aug 06, 2013
CLEARSPEC SINGLE USE VAGINAL SPECULUM
K130046 · HIB
Clearspec, LLC
Obstetrics & Gynecology · 210d
Cleared Aug 06, 2013
SIGNATURE PERSONALIZED PATIENT CARE SYSTEM - GLENOID GUIDE SYSTEM
K130126 · MBF
Biomet, Inc.
Orthopedic · 201d
Cleared Aug 06, 2013
THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.0
K130743 · LLZ
Ortho Kinematics, Inc.
Radiology · 140d
Cleared Aug 06, 2013
FLASH MINI OSTIAL SYSTEM - 3.0MM X 135CM, FLASH MINI OSTIAL SYSTEM - 3.5MM X...
K131450 · LOX
Ostial Corporation
Cardiovascular · 78d
Cleared Aug 06, 2013
MENICON NECT CONTACT LENS CASE
K131875 · LRX
Foresight Regulatory Strategies
Ophthalmic · 43d
Cleared Aug 06, 2013
CD HORIZON SPINAL SYSTEM
K132111 · NKB
Medtronic Sofamor Danek USA
Orthopedic · 28d