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

Filters: Cleared only ×
175,820 results
36937–36960 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 09, 2014
KLASSIC HD ACETABULAR INSERT WITH E-LINK POLY
K141972 · OQG
Total Joint Orthopedics, Inc.
Orthopedic · 80d
Cleared Oct 09, 2014
Chemtrue BUP/TCA Single/Multi-Panel Drug Screen Dip Card/Cup/Cassette Tests
K142396 · DJG
Chemtron Biotech, Inc.
Toxicology · 43d
Cleared Oct 08, 2014
FLUOR PROTECTOR S
K131487 · LBH
Ivoclar Vivadent, AG
Dental · 503d
Cleared Oct 08, 2014
GENESYS SPINE ANTERIOR CERVICAL PLATE II SYSTEM
K133245 · KWQ
Genesys Spine
Orthopedic · 351d
Cleared Oct 08, 2014
LONG PULSE ND: YAG LASER SYSTEM
K140249 · GEX
Advanced Technology Laser Co., Ltd.
General & Plastic Surgery · 250d
Cleared Oct 08, 2014
A&D MEDICAL UA-767F AND UA-767FAC DIGITAL BLOOD PRESSURE MONITOR
K141201 · DXN
A & D Co., Ltd.
Cardiovascular · 152d
Cleared Oct 08, 2014
NEEDLE VIEW CH SCOPE KITS
K141326 · HRX
Biovision Technologies, LLC
Orthopedic · 140d
Cleared Oct 08, 2014
IDC INTERLOCKING DETACHABLE COIL
K141378 · KRD
Boston Scientific Corporation
Cardiovascular · 134d
Cleared Oct 08, 2014
THE FIAGON NAVIGATION - EXTENDED INSTRUMENT SET ENT, REGISTRATIONPOINTER,...
K141456 · PGW
Fiagon GmbH
Ear, Nose, Throat · 128d
Cleared Oct 08, 2014
CLARITY
K141855 · IYE
Elekta , Ltd.
Radiology · 91d
Cleared Oct 08, 2014
BNX Fine Needle Aspiration System
K142198 · NEU
Covidien, LLC
General & Plastic Surgery · 58d
Cleared Oct 08, 2014
MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Aera, MAGNETOM Combi...
K142515 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 30d
Cleared Oct 07, 2014
LED CURING LIGHT
K133040 · EBZ
Monitex Industrial Co., Ltd.
Dental · 377d
Cleared Oct 07, 2014
SIMPLY SLICK PERSONAL LUBRICATING LOTION
K140304 · NUC
Simply Solutions, LLC
Obstetrics & Gynecology · 242d
Cleared Oct 07, 2014
FLEX-MT +
K140467 · IPF
Emsi
Physical Medicine · 225d
Cleared Oct 07, 2014
A&D MEDICAL UA-651 DIGITAL BLOOD PRESSURE MONITOR
K141160 · DXN
A & D Co., Ltd.
Cardiovascular · 155d
Cleared Oct 07, 2014
EMG WHITE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE)
K141510 · LZA
Eco Medi Glove Sdn. Bhd.
General Hospital · 120d
Cleared Oct 07, 2014
EMG BLUE NITRILE MEDICAL EXAMINATION GLOVE WITH CHEMOTHERAPY DRUG LABELING CLAIM
K141623 · LZA
Eco Medi Glove Sdn. Bhd.
General Hospital · 112d
Cleared Oct 07, 2014
VASSEN COLOR
K141699 · LPL
Vassen Co., Ltd.
Ophthalmic · 105d
Cleared Oct 07, 2014
RESIDUAL LIMB LENGTHENING SYSTEM
K141739 · HSB
Ellipse Technologies, Inc.
Orthopedic · 102d
Cleared Oct 07, 2014
888 WNLE POWERED WHEELCHAIR
K142027 · ITI
Pihsiang Machinery Mfg. Co., Ltd.
Physical Medicine · 74d
Cleared Oct 07, 2014
Neo Cosmo (Polymacon) Soft (Hydrophilic) Contact Lens
K142275 · LPL
Neo Vision Co., Ltd.
Ophthalmic · 53d
Cleared Oct 07, 2014
First Sign Drug of Abuse Dip Card Test/First Sign Drug of Abuse Cup Test
K142353 · DIO
W.H.P.M., Inc.
Toxicology · 47d
Cleared Oct 06, 2014
APEX MEDICAL CORP. ICH CPAP WITH PVA 9S-007XXX SERIES
K141522 · BZD
Apex Medical Corp.
Anesthesiology · 119d