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
36985–37008 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 02, 2014
EMERGE MEDICAL IM NAIL SYSTEM
K141347 · HSB
Emerge Medical
Orthopedic · 133d
Cleared Oct 02, 2014
NELLCOR PORTABLE SPO2 PATIENT MONITORING SYSTEM ( NPSPMS )
K141542 · DQA
Covidien, LLC
Anesthesiology · 114d
Cleared Oct 02, 2014
SAFE'N'SOUND STAKED PASSIVE DELIVERY SYSTEM - CONE VERSION
K141664 · MEG
Rexam Healthcare
General Hospital · 101d
Cleared Oct 02, 2014
Varian Verification System (VVS)
K142268 · IYE
Varian Medical Systems, Inc.
Radiology · 48d
Cleared Oct 02, 2014
BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel System,...
K142302 · CGA
Polymer Technology Systems, Inc.
Chemistry · 45d
Cleared Oct 01, 2014
INNESIS PEEK TL CAGE
K140577 · MAX
Bk Meditech, Co., Ltd.
Orthopedic · 209d
Cleared Oct 01, 2014
Barrx RFA Self Sizing Balloon Catheter
K142364 · GEI
Covidien, LLC
General & Plastic Surgery · 37d
Cleared Oct 01, 2014
DIVERGENCE Anterior Cervical Fusion System
K142450 · ODP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 29d
Cleared Oct 01, 2014
EXPEDIUM Spine System/Synapse System
K142460 · KWP
Johnson and Johnson
Orthopedic · 29d
Cleared Sep 30, 2014
SURGTEX POWDERED SURGICAL GLOVE, SURGTEX POWDERFREE POLYMER COATED SURGICAL...
K130450 · KGO
Purna Bina Sdn Bhd
General Hospital · 585d
Cleared Sep 30, 2014
FREESTYLE PRECISION NEO BLOOD GLUCOSE: MONITORING SYSTEM, TEST STRIPS (50CT),...
K140371 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 228d
Cleared Sep 30, 2014
COMP A-I-R
K141140 · CAF
Omron Healthcare, Inc.
Anesthesiology · 151d
Cleared Sep 30, 2014
AER-O-SCOPE COLONOSCOPE SYSTEM
K141286 · FDF
Gi View , Ltd.
Gastroenterology & Urology · 137d
Cleared Sep 30, 2014
PROFLUORO FLUORIDE VARNISH
K141422 · LBH
Pac-Dent International, Inc.
Dental · 123d
Cleared Sep 30, 2014
WAVELIGHT FS200 LASER SYSTEM
K141476 · OOE
Alcon Research, Ltd. Dba Alcon...
Ophthalmic · 118d
Cleared Sep 30, 2014
WINGMAN EXTENDABLE TIP SUPPORT CATHETER
K141547 · DQY
Reflow Medical
Cardiovascular · 111d
Cleared Sep 30, 2014
FUSE COLONOSCOPY SYSTEM
K141598 · FDF
Endochoice, Inc.
Gastroenterology & Urology · 109d
Cleared Sep 30, 2014
CLAVEGUARD FREEDOM SURGICAL LIGHT
K142076 · FSY
Dickson & Dickson Healthcare (Us), Inc.
General & Plastic Surgery · 61d
Cleared Sep 30, 2014
ESOPHYX2 HD
K142113 · ODE
Endogastric Solutions, Inc.
Gastroenterology & Urology · 57d
Cleared Sep 30, 2014
PolyCatch Retrieval Device
K142258 · FDI
Medi-Globe Corporation
Gastroenterology & Urology · 47d
Cleared Sep 29, 2014
HELICAL RIDGE PEEK INTERFERENCE SCREW
K141290 · HWC
MedShape, Inc.
Orthopedic · 133d
Cleared Sep 29, 2014
SCARLET AC-T SECURED ANTERIOR CERVICAL CAGE AND ASSOCIATED INSTRUMENTATION
K141314 · OVE
Spineart
Orthopedic · 132d
Cleared Sep 29, 2014
PRO-PICC WITH VALVE TECHNOLOGY
K141633 · LJS
Medical Components, Inc.
General Hospital · 103d
Cleared Sep 29, 2014
IMACOR ZURA EVO IMAGING SYSTEM
K142054 · IYO
Imacor, Inc.
Radiology · 62d