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
36361–36384 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 15, 2014
BruxZir Anterior
K143330 · EIH
Prismatik Dentalcraft, Inc.
Dental · 25d
Cleared Dec 12, 2014
SUMMED INFLATION DEVICE KIT
K133795 · MAV
Sunny Medical Device (Shenzhen) Co.,...
Cardiovascular · 364d
Cleared Dec 12, 2014
XPEED ANYRIDGE INTERNAL IMPLANT SYSYEM
K140091 · DZE
Megagen Implant Co., Ltd.
Dental · 332d
Cleared Dec 12, 2014
TRAUSIM DENTAL IMPLANT SYSTEM
K140202 · DZE
Jiangsu Trausim Medical Instrument
Dental · 319d
Cleared Dec 12, 2014
VELLA 5% SODIUM FLUORIDE VARNISH WITH NUFLUOR AND XYLITOL
K140350 · LBH
Preventive Technologies, Inc.
Dental · 304d
Cleared Dec 12, 2014
THERASNORE
K140663 · LRK
Distar, LLC
Dental · 269d
Cleared Dec 12, 2014
LEADPOINT FOCUS WORKSTSTION, LEADPOINT FOCUS NOTEBOOK SYSTEM
K140680 · GZL
Alpine Biomed Aps
Neurology · 269d
Cleared Dec 12, 2014
IPACS MEDICAL IMAGE MANAGEMENT SYSTEM
K140797 · LLZ
Visbion Limited
Radiology · 256d
Cleared Dec 12, 2014
ZHIDA NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR
K141303 · LZA
Zhida Glove Co., Ltd.
General Hospital · 207d
Cleared Dec 12, 2014
YONGXIN NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR
K141304 · LZA
Yongxin Healthcare Co., Ltd.
General Hospital · 207d
Cleared Dec 12, 2014
INFINITY EXPLORER SOFTWARE, C700 FOR IT PATIENT VICINITY WORKSTATION
K141756 · MSX
Draeger Medical Systems, Inc.
Cardiovascular · 165d
Cleared Dec 12, 2014
CONTRAST MONITORING SYSTEM DISPLAY, CONTRAST MONITORING SYSTEM SYRINGES
K142081 · DXT
Osprey Medical, Inc.
Cardiovascular · 134d
Cleared Dec 12, 2014
POOL NORM
K142132 · GGN
Diagnostics Stago S.A.S.
Hematology · 130d
Cleared Dec 12, 2014
TELESENSE
K142180 · DSI
Scottcare Corporation
Cardiovascular · 126d
Cleared Dec 12, 2014
DESIO (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and...
K142384 · LPL
Qualimed Srl
Ophthalmic · 108d
Cleared Dec 12, 2014
0.9% Sodium Chloride Injection, USP - 2.5 mL in 3 mL Syringe, 0.9% Sodium...
K142620 · NGT
Excelsior Medical Corporation
General Hospital · 87d
Cleared Dec 12, 2014
Bovie Ultimate High Frequency Electrosurgical Generator
K142975 · GEI
Bovie Medical Corporation
General & Plastic Surgery · 59d
Cleared Dec 11, 2014
G7 OSSEOTI ACETUBLAR SHELLS
K140669 · LPH
Biomet, Inc.
Orthopedic · 268d
Cleared Dec 11, 2014
OVINE TISSUE MATRIX(OTM)
K141053 · FTM
TELA Bio, Inc.
General & Plastic Surgery · 231d
Cleared Dec 11, 2014
SAPPHIRE INFUSION PUMP
K141389 · FRN
Q Core Medical , Ltd.
General Hospital · 198d
Cleared Dec 11, 2014
IBIS PEDICLE SCREW SYSTEM
K142146 · NKB
Ortho Development Corp.
Orthopedic · 128d
Cleared Dec 11, 2014
iTotal Posterior Stabilized (PS) Knee Replacement System
K142404 · JWH
Conformis, Inc.
Orthopedic · 106d
Cleared Dec 11, 2014
Varian Head Frame
K142560 · IYE
Varian Medical Systems, Inc.
Radiology · 91d
Cleared Dec 11, 2014
AngioVac Circuit
K142607 · DWE
Angiodynamics
Cardiovascular · 87d