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
46153–46176 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 20, 2011
BD GENEOHM VANR ASSAY
K102416 · NIJ
Bd Diagnostics Science
Microbiology · 422d
Cleared Oct 20, 2011
SYNTHES XRL
K103320 · MQP
Synthes Spine Co.Lp
Orthopedic · 342d
Cleared Oct 20, 2011
DIGIVIEW 250
K103348 · MQB
Kub Technologies, Inc.
Radiology · 339d
Cleared Oct 20, 2011
NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE
K110315 · QEZ
Nexgen Medical Systems, Inc.
Cardiovascular · 260d
Cleared Oct 20, 2011
VISUCON-F FROZEN COAG SCREEN N, VISUCON-F FROZEN COAG SCREEN ABN
K110432 · GGN
Affinity Biologicals, Inc.
Hematology · 247d
Cleared Oct 20, 2011
SMART TOUCH UVTHERAPY MULTIPLE MACHINE
K110912 · FTC
Daavlin Distributing Co.
General & Plastic Surgery · 202d
Cleared Oct 20, 2011
CARESTREAM PACS
K110919 · LLZ
Carestream Health, Inc.
Radiology · 202d
Cleared Oct 20, 2011
DERMAGRIP ULTRA POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES...
K110979 · LZA
Advanced Medical Products Sdn Bhd
General Hospital · 196d
Cleared Oct 20, 2011
XTRAFIX EXTERNAL FIXATION SYSTEM
K111155 · KTT
Extraortho, Inc.
Orthopedic · 178d
Cleared Oct 20, 2011
KC200, SURGICAL MASK, KC200, PROCEDURE MASK, KC300, SURGICALMASK,...
K111402 · FXX
Kimberly-Clark
General Hospital · 154d
Cleared Oct 20, 2011
QUANTA FLASH (TM) DGP SCREEN
K111414 · MST
Inova Diagnostics, Inc.
Immunology · 153d
Cleared Oct 20, 2011
DELTEX MEDICAL CARDIOQ EDM
K111542 · DPW
Deltex Medical Limited
Cardiovascular · 140d
Cleared Oct 20, 2011
ALERKAN SPIROMETRY FILTER
K111587 · BZG
Alerkan, Ltd.
Anesthesiology · 135d
Cleared Oct 20, 2011
POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED AND WHITE...
K111772 · LZA
Kossan Latex Industries(M)Sdn Bhd
General Hospital · 119d
Cleared Oct 20, 2011
DURA BLUE STERILIZATION WRAP
K112211 · FRG
Cardinal Health200, LLC
General Hospital · 79d
Cleared Oct 20, 2011
NEUROLAC(R) NERVE GUIDE
K112267 · JXI
Polyganics B.V.,
Neurology · 73d
Cleared Oct 20, 2011
OSTAR USB BLOOD PRESSURE MONITOR WITH SPECTRUM / P200 FOR UPPER ARM, AND M100...
K112269 · DXN
OSTAR MEDITECH CORP.
Cardiovascular · 73d
Cleared Oct 20, 2011
DURA BLUE STERILIZATION WRAP
K112283 · FRG
Cardinal Health200, LLC
General Hospital · 72d
Cleared Oct 20, 2011
X-TRA BASE
K112374 · EBF
Voco GmbH
Dental · 64d
Cleared Oct 20, 2011
THE ONCONTROL BONE ACCESS SYSTEM BY VIDACARE
K112468 · KNW
Regulatory Specialists, Inc.
Gastroenterology & Urology · 55d
Cleared Oct 20, 2011
VANISHPOINT BLOOD COLLECTION SET
K112512 · FPA
Retractable Technologies, Inc.
General Hospital · 51d
Cleared Oct 20, 2011
LIPSONIX(R) SYSTEM MODEL 2
K112626 · OHV
Medicis Technologies Corporation
General & Plastic Surgery · 41d
Cleared Oct 20, 2011
VIZION DR
K112661 · MQB
Viztek, LLC
Radiology · 37d
Cleared Oct 20, 2011
TIGER HEADLESS CANNULATED SCREWS
K112737 · HWC
Trilliant Surgical, Ltd.
Orthopedic · 30d