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

Filters: Cleared only ×
176,076 results
58993–59016 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 03, 2007
MODIFICATION TO ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 2000
K071341 · DWJ
Medivance, Inc.
Cardiovascular · 81d
Cleared Aug 03, 2007
NOBELACTIVE INTERNAL CONNECTION IMPLANT
K071370 · DZE
Nobel Biocare AB
Dental · 79d
Cleared Aug 03, 2007
PXS-810, PODIATRY X-RAY SYSTEM
K071392 · KPR
Source-Ray, Inc.
Radiology · 77d
Cleared Aug 03, 2007
INION HEXALON BIODEGRADABLE ACL/PCL SCREW
K071464 · HWC
Inion OY
Orthopedic · 66d
Cleared Aug 03, 2007
INTRINSIC THERAPEUTICS FIXATION STAPLE
K071637 · JDR
Intrinsic Therapeutics Incorporated
Orthopedic · 49d
Cleared Aug 03, 2007
LLOYD LINDEN, MODEL E04
K071761 · IPL
Lloyd Linden, Inc.
Physical Medicine · 35d
Cleared Aug 03, 2007
CONVERTIBLE I-SERIES POSITIONING AND TRANSFER CHAIR
K071793 · INO
Barton Medical Corp.
Physical Medicine · 32d
Cleared Aug 03, 2007
MEDITECH AMBULATORY BLOOD PRESSURE MONITOR, MODEL ABPM-05
K071960 · DXN
Meditech Kft.
Cardiovascular · 18d
Cleared Aug 03, 2007
MYLAB30, MODEL 7300
K071996 · IYO
Esaote, S.P.A.
Radiology · 8d
Cleared Aug 03, 2007
QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF MONODERM
K072028 · GAM
Surgical Specialties Corp
General & Plastic Surgery · 10d
Cleared Aug 03, 2007
C-JAWS CERVICAL COMPRESSIVE MINI FRAME
K072040 · KWQ
Medicrea Technologies
Orthopedic · 9d
Cleared Aug 03, 2007
MODIFICATION TO: OSTEOGRAF/N-700
K072058 · LYC
Dentsply Interntional
Dental · 8d
Cleared Aug 02, 2007
TRUEFIELD ANALYZER
K063310 · HPT
Seeing Machines Limited
Ophthalmic · 273d
Cleared Aug 02, 2007
OPACIDEN SOLUTION
K070627 · MED
Ciden Technologies, LLC
General Hospital · 149d
Cleared Aug 02, 2007
SENTINEL LITHIUM ASSAY
K070987 · NDW
SENTINEL CH. SpA
Toxicology · 118d
Cleared Aug 02, 2007
BC (BODY COMPOSITION SOFTWARE)
K070999 · MNW
Rjl Systems, Inc.
Gastroenterology & Urology · 115d
Cleared Aug 02, 2007
BOSTON XO (HEXAFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON ES (ENFLUFOCON...
K071043 · HQD
Bausch & Lomb, Inc.
Ophthalmic · 112d
Cleared Aug 02, 2007
SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET, MODEL 61000, 10200
K071079 · LKN
Gambro Bct, Inc.
Gastroenterology & Urology · 107d
Cleared Aug 02, 2007
TALON AND REVERE
K071245 · EBI
Talon Acrylics, Inc.
Dental · 91d
Cleared Aug 02, 2007
OPUS TWINLOCK KNOTLESS FIXATION DEVICE
K071374 · MBI
Arthrocare Corp.
Orthopedic · 78d
Cleared Aug 02, 2007
DEPUY LPS DIAPHYSEAL AND METAPHYSEAL SLEEVES
K071417 · MBH
DePuy Orthopaedics, Inc.
Orthopedic · 73d
Cleared Aug 02, 2007
SBI STAFIX
K071479 · JDR
Small Bone Innovations, Inc.
Orthopedic · 65d
Cleared Aug 02, 2007
INSTRUMED RETRACTORS
K071771 · GZT
Instrumed International, Inc.
Neurology · 34d
Cleared Aug 02, 2007
HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE, HYPODERMIC NEEDLE-PRO EDGE SAFETY...
K071785 · FMI
Smiths Medical Asd, Inc.
General Hospital · 31d