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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
62521–62544 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 14, 2006
GOOD MEDY, DISPOSABLE THERMOMETER SHEATHS
K061007 · FLL
Good Medy Enterprise , Ltd.
General Hospital · 64d
Cleared Jun 14, 2006
IR PRO 250
K061080 · ILY
Lhasa Oms, Inc.
Physical Medicine · 57d
Cleared Jun 14, 2006
NCB PLATING SYSTEM, PROXIMAL TIBIA PLATES
K061211 · HRS
Zimmer GmbH
Orthopedic · 44d
Cleared Jun 14, 2006
MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3AX1-4U
K061403 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 26d
Cleared Jun 14, 2006
SIGMA 5000 SERIES, IMAGIC
K061437 · IYN
Kontron Medical Systems Sas
Radiology · 21d
Cleared Jun 14, 2006
ASTROTILT MANUAL WHEELCHAIR
K061475 · IOR
Pdg Product Design Group, Inc.
Physical Medicine · 15d
Cleared Jun 13, 2006
ICHEM 100 URINE CHEMISTRY ANALYZER
K060280 · JIL
Iris International, Inc.
Chemistry · 131d
Cleared Jun 13, 2006
EPILONG KIT FOR ANESTHESIOLOGY
K060311 · CAZ
PAJUNK GmbH Medizintechnologie
Anesthesiology · 125d
Cleared Jun 13, 2006
DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODELS DVS-I-11, DVS...
K061051 · LHN
Sicel Technologies, Inc.
Radiology · 57d
Cleared Jun 13, 2006
BRAINACQUIRERX / BRAINPROCESSRX DATA SUITE VERSION 1.0
K061255 · LNH
Kyron Clinical Imaging, Inc.
Radiology · 40d
Cleared Jun 13, 2006
DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT FOR COBAS INTEGRA AND HOMOCYSTEINE...
K061296 · LPS
Diazyme Laboratories
Chemistry · 35d
Cleared Jun 13, 2006
THINK POSITIVE DIABETES MANAGEMENT SYSTEM (T+DIABETES SYSTEM)
K061328 · NBW
E-San Limited
Chemistry · 32d
Cleared Jun 12, 2006
DERMOSONIC NON-INVASIVE SUBDERMAL THERAPY SYSTEM
K052934 · IMI
S.O.R. Internacional, S.A.
Physical Medicine · 236d
Cleared Jun 12, 2006
DAI-R
K060141 · KZH
Shl Medical, USA
General Hospital · 144d
Cleared Jun 12, 2006
ULTRATINE TRANSBLEPH
K060248 · HWC
Coapt Systems, Inc.
Orthopedic · 132d
Cleared Jun 12, 2006
ULTRATINE FOREHEAD
K060249 · HWC
Coapt Systems, Inc.
Orthopedic · 132d
Cleared Jun 12, 2006
SAFE TIP SYRINGE
K060668 · MEG
Devon Safety Products, Inc.
General Hospital · 90d
Cleared Jun 12, 2006
EASY X-TRAC SYSTEM
K060691 · EMG
A. Titan Instruments, Inc.
Dental · 89d
Cleared Jun 12, 2006
VERSA-DIAL HUMERAL HEAD PROSTHESIS
K060716 · MBF
Biomet Manufacturing Corp
Orthopedic · 87d
Cleared Jun 12, 2006
ANGIODYNAMICS, INC. VENACURE PROCEDURE KIT
K061178 · GEX
AngioDynamics, Inc.
General & Plastic Surgery · 46d
Cleared Jun 12, 2006
PALMLIGHT 10, MODEL 001-00030
K061341 · EBZ
CAO Group, Inc.
Dental · 28d
Cleared Jun 12, 2006
EXACTECH EQUINOXE SHOULDER STEMS
K061454 · HSD
Exactech, Inc.
Orthopedic · 18d
Cleared Jun 12, 2006
OSOM INFLUENZA A&B TEST
K061508 · PSZ
Genzyme Corp.
Microbiology · 11d
Cleared Jun 09, 2006
FIRST SIGN DRUG OF ABUSE URINE SCREENING TEST
K052197 · DJR
W.H.P.M., Inc.
Toxicology · 301d