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
38857–38880 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 28, 2014
GLADIATOR ELITE PTA BALLOON DILATATION CATHETER
K132810 · LIT
Boston Scientific Corp
Cardiovascular · 172d
Cleared Feb 28, 2014
OXICARE FINGERTIP PULSE OXIMETER
K133090 · DQA
Delbio Incorporation
Anesthesiology · 151d
Cleared Feb 28, 2014
FLOWTRON ACS800 PUMP AND TRI PULSE GARMENTS
K133119 · JOW
Arjohuntleigh Polska SP Z.O.O.
Cardiovascular · 151d
Cleared Feb 28, 2014
ND: YAG LASER SYSTEM
K133158 · GEX
Beijing Toplaser Technology Co., Ltd.
General & Plastic Surgery · 134d
Cleared Feb 28, 2014
FIXOS SCREW SYSTEM
K133451 · HWC
Stryker Trauma AG
Orthopedic · 108d
Cleared Feb 28, 2014
THE DOME S6C
K133609 · LLZ
Nds Surgical Imaging
Radiology · 95d
Cleared Feb 28, 2014
SCENIUM
K133654 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 93d
Cleared Feb 28, 2014
ICONIX ALL SUTURE ANCHORS
K133671 · MBI
Stryker Corp.
Orthopedic · 91d
Cleared Feb 28, 2014
PRESTO BREAST BIOPSY DEVICE
K133702 · KNW
Sontina Medical, LLC
Gastroenterology & Urology · 87d
Cleared Feb 28, 2014
CHARLOTTE CLAW PLATE SYSTEM
K133715 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 85d
Cleared Feb 28, 2014
TENSYN BAND
K133858 · HTN
Dallen Medical, Inc.
Orthopedic · 71d
Cleared Feb 28, 2014
DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
K133999 · MCW
Cardiovascular Systems, Inc.
Cardiovascular · 63d
Cleared Feb 28, 2014
MONODERM SURGICAL SUTURE
K140227 · GAM
Surgical Specialties Corp
General & Plastic Surgery · 29d
Cleared Feb 28, 2014
OSTEOMED EXTREMIFUSE SYSTEM
K140283 · HWC
Osteomed
Orthopedic · 24d
Cleared Feb 27, 2014
M SERIES PATIENT MONITOR
K131876 · MHX
Mid-Link Consulting Co, Ltd.
Cardiovascular · 248d
Cleared Feb 27, 2014
U&U STERILE PISTON SYRINGE WITHOUT NEEDLE
K132553 · FMF
U&U Medical Technology Co, Ltd.
General Hospital · 197d
Cleared Feb 27, 2014
SARNS SOFT-FLOW EXTENDED AORTIC CANNULA
K132811 · DWF
Terumo Cardiovascular Systems...
Cardiovascular · 171d
Cleared Feb 27, 2014
MADSEN ACCUSCREEN TYPE 1077
K132957 · GWJ
Gn Otometrics
Neurology · 160d
Cleared Feb 27, 2014
COMPACT INTUITIV
K133115 · HQC
Abbott Medical Optics, Inc.
Ophthalmic · 150d
Cleared Feb 27, 2014
EMV3.1 PRO BLOOD GLUCOSE SYSTEM AND EMV3.1 SELF MONITORING BLOOD GLUCOSE SYSTEM
K133647 · NBW
Eps Bio Technology Corp.
Chemistry · 92d
Cleared Feb 27, 2014
SENSITITRE 18-24 HOUR MIC SUCEPTIBILITY SYSTEM
K133773 · JWY
Thermo Fisher Scientific
Microbiology · 77d
Cleared Feb 27, 2014
ARTHREX IBALANCE TKA SYSTEM
K133854 · JWH
Arthrex, Inc.
Orthopedic · 70d
Cleared Feb 27, 2014
TARGET3D FUSION
K140033 · LLZ
Convergent Life Sciences, Inc.
Radiology · 51d
Cleared Feb 27, 2014
ELLIPSE MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
K140178 · PGN
Ellipse Technologies, Inc.
Orthopedic · 34d