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
77137–77160 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 15, 2002
EXCELSIOR TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC.
K013342 · CGA
Chay Medical, LLC
Chemistry · 129d
Cleared Feb 15, 2002
PACIFIC HEMOSTASIS REFERENCE EMULSION
K013397 · JIX
Fisher Diagnostics
Hematology · 123d
Cleared Feb 15, 2002
CANDELA SMOOTHBEAM LASER SYSTEM
K013825 · GEX
Candela Corp.
General & Plastic Surgery · 88d
Cleared Feb 15, 2002
APPLE MEDICAL MOBIUS ELASTIC RETRACTOR
K014005 · GCJ
Apple Medical Corp.
General & Plastic Surgery · 72d
Cleared Feb 15, 2002
SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATOR
K014173 · DKJ
Beckman Coulter, Inc.
Toxicology · 57d
Cleared Feb 15, 2002
NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE AND YELLOWISH WHITE
K014284 · LZA
Formosa Glove Industrial Co., Ltd.
General Hospital · 50d
Cleared Feb 15, 2002
MB 102 MILLENNIUM BLADES
K020122 · HNO
Millennium Biomedical, Inc.
Ophthalmic · 32d
Cleared Feb 15, 2002
SIEMENS INFINITY SC 6002XL MODIFICATIONS
K020144 · DRT
Siemens Medical Solutions USA, Inc.
Cardiovascular · 30d
Cleared Feb 15, 2002
MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEM
K020196 · MNH
Sulzer Spine-Tech
Orthopedic · 24d
Cleared Feb 15, 2002
A1CNOW FOR RX HOME USE
K020234 · LCP
Metrika, Inc.
Hematology · 23d
Cleared Feb 15, 2002
A1CNOW FOR PROFESSIONAL USE
K020235 · LCP
Metrika, Inc.
Hematology · 23d
Cleared Feb 15, 2002
PARAGON INFUSION SYSTEM
K020251 · FRN
I-Flow Corp.
General Hospital · 22d
Cleared Feb 15, 2002
CGS-30A MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER, MODEL TSX-101A
K020385 · JAK
Toshiba America Medical Systems, In.C
Radiology · 10d
Cleared Feb 14, 2002
GINDA GUARD
K011239 · EBD
Cosmedent, Inc.
Dental · 297d
Cleared Feb 14, 2002
REPROCESSED STONE RETRIEVAL BASKETS
K012581 · FFL
Sterilmed, Inc.
Gastroenterology & Urology · 189d
Cleared Feb 14, 2002
REPROCESSED ENDOSCOPIC ELECTRODES
K012685 · NLW
Sterilmed, Inc.
Gastroenterology & Urology · 184d
Cleared Feb 14, 2002
DENTIN CONDITIONING AND ADHESIVE SYSTEM (BOND-1)
K013542 · KLE
Jeneric/Pentron, Inc.
Dental · 120d
Cleared Feb 14, 2002
MEDTRADE PRODUCTS SILICONE SCAR THERAPY GEL, SPENCO MEDICAL CORP. 2ND SKIN...
K014036 · MDA
Medtrade Products , Ltd.
General & Plastic Surgery · 69d
Cleared Feb 14, 2002
PROMOGRAN MATRIX WOUND DRESSING
K014129 · KGN
Johnson & Johnson Medical, Ltd.
General & Plastic Surgery · 59d
Cleared Feb 14, 2002
NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE, PURPLE
K014285 · LZA
Formosa Glove Industrial Co., Ltd.
General Hospital · 49d
Cleared Feb 14, 2002
ENAMEL BONDING SYSTEM
K020050 · KLE
Rite-Dent Manufacturing Corp.
Dental · 38d
Cleared Feb 14, 2002
XERAFIT
K020062 · EJH
Metalor Technologies USA
Dental · 37d
Cleared Feb 14, 2002
SMARTFLOW PULSE TRANSMISSION COEFFICIENT
K020127 · DQK
Florence Medical , Ltd.
Cardiovascular · 30d
Cleared Feb 14, 2002
MODIFICATION TO PASS SPINAL SYSTEM
K020236 · KWP
Encore Orthopedics, Inc.
Orthopedic · 22d