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
76105–76128 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 04, 2002
ANIMUS EZSERTER INFUSION SET INSERTER
K021700 · KZH
Animas Corp.
General Hospital · 12d
Cleared Jun 03, 2002
REPROCESSED ARTHROSCOPIC SHAPERS
K012667 · HRX
Surgical Instruments Service and...
Orthopedic · 294d
Cleared Jun 03, 2002
SYSTEM 100
K013733 · KDI
Chf Solutions, Inc.
Gastroenterology & Urology · 206d
Cleared Jun 03, 2002
FAMILY OF ALTUS MEDICAL MODIFIED COOLGLIDE AESTHETIC LASERS, MODELS COOLGLIDE...
K014040 · GEX
Altus Medical, Inc.
General & Plastic Surgery · 178d
Cleared Jun 03, 2002
TRIAGE DRUGS OF ABUSE PANEL PLUS PPX, MODEL CATALOG 92002
K014247 · DKZ
Biosite Incorporated
Toxicology · 159d
Cleared Jun 03, 2002
WALLACH LOOP ELECTRODE
K020711 · GEI
Wallach Surgical Devices, Inc.
General & Plastic Surgery · 90d
Cleared Jun 03, 2002
SECURLINE UMBILICAL CORD CLAMP #3505 STERILE #3515 NON-STERILE
K020718 · HFW
Precision Dynamics Corp.
Obstetrics & Gynecology · 90d
Cleared Jun 03, 2002
TRAATEK COTTONOID PATTIES
K020736 · HBA
Traatek, Inc.
Neurology · 89d
Cleared Jun 03, 2002
BCI 3178 PEDIATRIC PULSE OXIMETRY SENSOR
K020739 · DQA
Bci, Inc.
Anesthesiology · 89d
Cleared Jun 03, 2002
NAVIPRO
K020764 · HAW
Kinamed, Inc.
Neurology · 88d
Cleared Jun 03, 2002
MEDORAL HYGIENIC TOOTHBRUSH WITH DENTOSAN FILAMENTS
K020776 · EFW
Coronet Group North America, LLC
Dental · 84d
Cleared Jun 03, 2002
SCOUT (SINUS CORNARIUS UTILITY TOOL), MODEL 335 117
K020821 · DQX
Biotronik, Inc.
Cardiovascular · 82d
Cleared Jun 03, 2002
DEVILBISS MODEL 9200D HEATED HUMIDIFIER SYSTEM
K020900 · BTT
Sunrise Medical Hhg, Inc.
Anesthesiology · 75d
Cleared Jun 03, 2002
MICROSCAN MICROSTREP PLUS PANEL-MEROPENEM
K020938 · JWY
Dade Microscan, Inc.
Microbiology · 73d
Cleared Jun 03, 2002
ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG100
K021032 · CKG
Scantibodies Laboratory, Inc.
Chemistry · 66d
Cleared Jun 03, 2002
CHARE CARIOVASCULAR PATCH
K021129 · DXZ
Chase Medical, Inc.
Cardiovascular · 56d
Cleared Jun 03, 2002
ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS)
K021257 · LKJ
Diagnostic Products Corp.
Immunology · 45d
Cleared Jun 03, 2002
MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM
K021448 · NBW
Roche Diagnostics Corp.
Chemistry · 28d
Cleared May 31, 2002
INPATH E2 COLLECTOR
K013258 · HHT
Molecular Diagnostics
Obstetrics & Gynecology · 242d
Cleared May 31, 2002
ENTERYX INJECTOR
K013712 · FBK
Enteric Medical Technologies
Gastroenterology & Urology · 204d
Cleared May 31, 2002
MAXISTAT PVA FOAM EMBOLIZATION PARTICLES
K020033 · HCG
Surgica Corp.
Neurology · 147d
Cleared May 31, 2002
RENUT MULTIPLUS MULLTI-PURPOSE SOLUTION
K020802 · LYL
Bausch & Lomb, Incorporated
Ophthalmic · 80d
Cleared May 31, 2002
AXSYM INTACT PTH, MODEL 2G06
K020945 · CEW
Diagnostic Systems Laboratories, Inc.
Chemistry · 67d
Cleared May 31, 2002
SHANGHAI GLOVMAX ENTERPRISE POWDERED BLUE NITRILE EXAMINATION GLOVES
K021000 · LZA
Shanghai Glovmax Enterprise Co.,Ltd
General Hospital · 64d