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
46609–46632 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 31, 2011
CAPSURE(R) PS SYSTEM
K111913 · MNI
Spine Wave, Inc.
Orthopedic · 56d
Cleared Aug 31, 2011
STEERABLE GUIDE CATHETER
K112239 · DRA
Abbott Vascular
Cardiovascular · 27d
Cleared Aug 31, 2011
S-CATH ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEM
K112376 · FLL
Circa Scientific, LLC
General Hospital · 14d
Cleared Aug 30, 2011
TYSONBIO BLOOD GLUCOSE MONITORING SYSTEM, MODELS AC100 AND AC200
K101543 · NBW
Tyson Bioresearch, Inc.
Chemistry · 453d
Cleared Aug 30, 2011
RIGHTON ZOOM SLIT LAMP MICROSCOPE WITH PHOTO OPTION
K110129 · HJO
Rightmedical Products, LLC
Ophthalmic · 224d
Cleared Aug 30, 2011
FRIENDSHIP MEDICAL DISPOSABLE PRE-GELLED AG / AGCL SURFACE ELECTRODE
K110289 · GXY
Xian Friendship Medical Electronics...
Neurology · 210d
Cleared Aug 30, 2011
INTROCAN SAFETY (R) 3 CLOSED IV CATHETER 18GA X 1-3/4 (45MM) AND 18GA X 1-1/4...
K111236 · FOZ
B.Braun Melsungen AG
General Hospital · 120d
Cleared Aug 30, 2011
ZYTO HAND CRADLE
K111308 · GZO
Zyto Technologies, Inc.
Neurology · 112d
Cleared Aug 30, 2011
DEPUY STTUNE (TM) PS KNEE SYSTEM
K111433 · OIY
DePuy Orthopaedics, Inc.
Orthopedic · 99d
Cleared Aug 30, 2011
WIRELESS/WIRED FDR D-EVO FLAT PANCEL DETECTOR SYSTEM MODEL DR-ID600 W/DR-ID611SE
K111548 · MQB
Fujifilm Medical System U.S.A., Inc.
Radiology · 88d
Cleared Aug 30, 2011
PALINDROME RT CHRONIC CATHETER
K111817 · MSD
Covidien
Gastroenterology & Urology · 64d
Cleared Aug 30, 2011
TSRH SPINAL SYSTEMS
K111942 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 53d
Cleared Aug 30, 2011
ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL I,...
K112029 · JIX
Elitechgroup
Chemistry · 46d
Cleared Aug 30, 2011
MONICA IF24
K112163 · OSP
Monica Healthcare
Obstetrics & Gynecology · 34d
Cleared Aug 29, 2011
HARMONIE SYSTEM
K083577 · GWQ
Stellate Systems
Neurology · 999d
Cleared Aug 29, 2011
VYSIS EGR1 FISH PROBE KIT (VYSIS LSI EGR1 SPECTRUM/ORANGE/D5S23, D5S721,...
K091960 · OWK
Abbott Molecular, Inc.
Pathology · 789d
Cleared Aug 29, 2011
AIDA HD CONNECT WITH SMARTSCREEN / BLU-RAY DRIVE / SMARTSCREEN WITH BLU-RAY...
K103308 · LLZ
KARL STORZ Endoscopy-America, Inc.
Radiology · 293d
Cleared Aug 29, 2011
INQU PASTE MIX PLUS
K103799 · MQV
Isto Technologies, Inc.
Orthopedic · 244d
Cleared Aug 29, 2011
NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEM
K110648 · CHL
Nova Biomedical Corporation
Chemistry · 178d
Cleared Aug 29, 2011
BLUEPHASE STYLE
K110756 · EBZ
Ivoclar Vivadent, Inc.
Dental · 164d
Cleared Aug 29, 2011
4 SERIES PHOTOTHERAPY UNIT MODEL 4 SERIES
K111172 · FTC
Daavlin Distributing Co.
General & Plastic Surgery · 125d
Cleared Aug 29, 2011
SONO-SERIES CORNERSTONE TECHNIQUE
K111374 · BSP
PAJUNK GmbH Medizintechnologie
Anesthesiology · 105d
Cleared Aug 29, 2011
MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, PHARMGUARD TOOLBOX 2 MEDICATION...
K111386 · FRN
Smiths Medical MD, Inc.
General Hospital · 103d
Cleared Aug 29, 2011
NOVAE SUNFIT TH DUAL MOBILITY ACETABULAR CUP MODEL SUNFIT TH (METAL-BACK),...
K111572 · LZO
Serf
Orthopedic · 84d