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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
64609–64632 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 17, 2005
MINDSTATE FUNCTIONAL DATA ACQUISITION DEVICE (FDAD), VERSION 1.0
K052571 · LNH
Neurognostics, Inc.
Radiology · 28d
Cleared Oct 17, 2005
ROTATOR CUFF QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE)
K052630 · HWC
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 21d
Cleared Oct 17, 2005
DUAL SHOT - CONTRAST DELIVERY SYSTEM
K052633 · DXT
Nemoto Kyorindo Co., Ltd.
Cardiovascular · 21d
Cleared Oct 17, 2005
MODEL 672-BD, HOME UVB LIGHT SOURCE (JORDAN LIGHT)
K052660 · FTC
The Richmond Light Co.
General & Plastic Surgery · 20d
Cleared Oct 17, 2005
KING I POWERED SCOOTER, MODEL CTL-11
K052673 · INI
King I Tech Corporation
Physical Medicine · 20d
Cleared Oct 17, 2005
NURSE'S ASSISTANT 1.7 O.R. CONTROL SYSTEM
K052740 · GCJ
Conmed Integrated Systems (Cmis)
General & Plastic Surgery · 17d
Cleared Oct 17, 2005
MYLAB30, 50 AND 70 SYSTEMS UPGRADE, MODELS 7300, 7350, 6150
K052805 · IYN
Esaote, S.P.A.
Radiology · 13d
Cleared Oct 17, 2005
BURANE
K052806 · GEX
Wavelight Laser Technologie AG
General & Plastic Surgery · 13d
Cleared Oct 14, 2005
CHRONO-LOG WHOLE BLOOD LUMI-AGGREGOMETER, MODEL 700
K050265 · JOZ
Chrono-Log Corp.
Hematology · 252d
Cleared Oct 14, 2005
MILO DENTAL IMPLANT SYSTEM
K050970 · DZE
Intra-Lock International
Dental · 179d
Cleared Oct 14, 2005
IPS E.MAX CAD/IPS E.MAX ZIRCAD
K051705 · EIH
Ivoclar Vivadent, Inc.
Dental · 112d
Cleared Oct 14, 2005
ATLANTIS ABUTMENT IN ZIRCONIA, ATLANTIS GEMINI ABUTMENT IN ZIRCONIA, ATLANTIS...
K052070 · NHA
Atlantis Components, Inc.
Dental · 74d
Cleared Oct 14, 2005
STANDARD, SPECIAL, SPECIAL+, SNEEDLE B-TYPE AND SNEEDLE J-TYPE ACUPUNCTURE...
K052085 · MQX
Asia-Med GmbH and CO KG
General Hospital · 73d
Cleared Oct 14, 2005
PROMETAL HN86
K052463 · EJT
Prometal Technologies
Dental · 36d
Cleared Oct 14, 2005
DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES
K052582 · CCK
Ge Healthcare
Anesthesiology · 24d
Cleared Oct 13, 2005
IMMUNALYSIS OPIATES ELISA FOR ORAL FLUIDS
K051626 · DJG
Immunalysis Corporation
Toxicology · 115d
Cleared Oct 13, 2005
EVIS EXERA 160A SYSTEM
K051645 · NWB
Olympus Medical Systems Corporation
Gastroenterology & Urology · 115d
Cleared Oct 13, 2005
KENDALL SCD SLEEVES (EXTRA LARGE KNEE, EXTRA LARGE THIGH), KENDALL SCD...
K051805 · JOW
Tyco Healthcare/Kendall
Cardiovascular · 100d
Cleared Oct 13, 2005
ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEM WITH PATIENT CONTROL MODULE
K052171 · FRN
Zimmer, Inc.
General Hospital · 65d
Cleared Oct 13, 2005
IISIS, VERSION 1.0
K052244 · MOD
Innovision Medical Technologies, LLC
Anesthesiology · 57d
Cleared Oct 13, 2005
ETEST TIGECYCLINE GRAM POSITIVE AND GRAM NEGATIVE AEROBIC BACTERIA,...
K052366 · JWY
Ab Biodisk
Microbiology · 45d
Cleared Oct 13, 2005
BELMONT BUDDY FLUID WARMER
K052547 · BSB
Belmont Instrument Corp.
Hematology · 27d
Cleared Oct 13, 2005
HYBRID ANTERIOR CERVICAL PLATE SYSTEM
K052552 · KWQ
Depuy Spine, Inc.
Orthopedic · 27d
Cleared Oct 13, 2005
ZIMMER DENTAL HEX-LOCK PREPARED ABUTMENT (STRAIGHT & ANGLED)
K052600 · NHA
Zimmer Dental, Inc.
Dental · 22d