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
78193–78216 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 05, 2001
EVERSTICK
K011788 · EBI
Stick Tech , Ltd.
Dental · 150d
Cleared Nov 05, 2001
EVERSTICKNET
K011799 · EBI
Stick Tech , Ltd.
Dental · 150d
Cleared Nov 05, 2001
ONTRAK TESTCARD 9
K012396 · DKZ
Roche Diagnostics Corp.
Toxicology · 101d
Cleared Nov 05, 2001
ARAMIS DERMATLOGIC LASER
K012545 · GEX
Lumedics, Ltd.
General & Plastic Surgery · 90d
Cleared Nov 05, 2001
SCITON IMAGE HAIR REMOVAL LASER
K012552 · GEX
Sciton, Inc
General & Plastic Surgery · 89d
Cleared Nov 05, 2001
PRIME-DENT CHEMICAL CURE PIT & FISSURE SEALANT
K012794 · EBF
Prime Dental Manufacturing, Inc.
Dental · 76d
Cleared Nov 05, 2001
THE V BAG, CATALOG NUMBER VB1800
K012942 · DTN
Circulatory Technology, Inc.
Cardiovascular · 66d
Cleared Nov 02, 2001
MODIFICATION TO BIOZ.COM HEMODYNAMIC MONITOR
K011439 · DSB
Cardiodynamics International Corp.
Cardiovascular · 176d
Cleared Nov 02, 2001
GLYCOSAL II HBA 1C TEST
K011933 · LCP
Provalis Diagnostics , Ltd.
Chemistry · 135d
Cleared Nov 02, 2001
SMITH & NEPHEW PHOENIX 5.0 ALLOGRAFT ANCHOR KIT
K011985 · MAI
Smith & Nephew, Inc.
Orthopedic · 129d
Cleared Nov 02, 2001
DEVICE MODIFICATION OF ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE
K012147 · KNT
Zevex, Inc.
Gastroenterology & Urology · 115d
Cleared Nov 02, 2001
KADANCE 2000
K012492 · LBB
Kada Research, Inc.
Neurology · 91d
Cleared Nov 02, 2001
DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION, N-DISXXXX
K012531 · MSX
Datex-Ohmeda
Cardiovascular · 88d
Cleared Nov 02, 2001
REPROCESSED POWERED ARTHROSCOPIC ACCESSORIES
K012536 · HRX
Sterilmed, Inc.
Orthopedic · 87d
Cleared Nov 02, 2001
OPTIMA URS UNIVERSAL RADIOGRAPHIC SYSTEM
K012546 · KPR
Sedecal USA, Inc.
Radiology · 87d
Cleared Nov 02, 2001
DEEP GRAY
K012563 · LLZ
Cortechs Labs, Inc.
Radiology · 85d
Cleared Nov 02, 2001
ADVANCE UNICONDYLAR KNEE SYSTEM
K012591 · HRY
Wrightmedicaltechnologyinc
Orthopedic · 84d
Cleared Nov 02, 2001
OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER & DIGITAL DOLPHIN DISPOSABLE...
K012626 · DQA
Osi Medical, Inc.
Anesthesiology · 81d
Cleared Nov 02, 2001
ICONNECTION 3D
K012779 · LLZ
Hinnovation, Inc.
Radiology · 74d
Cleared Nov 02, 2001
STRIPMAX 1210 URINE CHEMISTRY ANALYZER, URIMATE REAGENT STRIP FOR URINALYSIS
K012829 · KQO
Biocare Corp.
Chemistry · 71d
Cleared Nov 02, 2001
PORTADUR P 2, MODEL #2031
K012843 · EJT
Wieland Edelmetalle GmbH & Co.
Dental · 71d
Cleared Nov 02, 2001
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K012921 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 63d
Cleared Nov 02, 2001
VARICES INJECTION NEEDLE
K012977 · FBK
Endo-Therapeutics, Inc.
Gastroenterology & Urology · 58d
Cleared Nov 02, 2001
MINIME NASAL MASK, MODEL P/N 50220
K013306 · BZD
Sleepnet Corporation
Anesthesiology · 29d