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
77065–77088 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 26, 2002
AURELIA CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH ALOE...
K013953 · LYY
Supermax Glove Manufacturing Sdn Bhd
General Hospital · 88d
Cleared Feb 26, 2002
ACUVUE BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES
K013973 · LPL
Vistakon
Ophthalmic · 85d
Cleared Feb 26, 2002
LATEX POWDERFREE STERILE EXAMINATION GLOVES, MODELS-EXTRA SMALL, SMALL,...
K013996 · LYY
Pt. Maja Agung Latexindo
General Hospital · 85d
Cleared Feb 26, 2002
VINYL EXAMINATION GLOVES STERILE POWEDERED
K020044 · LYZ
Primus Gloves Private , Ltd.
General Hospital · 50d
Cleared Feb 26, 2002
CHASE CARDIOVASCULAR PATCH KIT
K020132 · DXZ
Chase Medical, Inc.
Cardiovascular · 42d
Cleared Feb 26, 2002
MEDIAL ROTATION KNEE SYSTEM
K020214 · JWH
Engineering Consulting Services, Inc.
Orthopedic · 35d
Cleared Feb 26, 2002
D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR
K020351 · DTZ
Dideco S.P.A.
Cardiovascular · 22d
Cleared Feb 26, 2002
SURGICAL DYNAMICS OGDEN SUTURE ANCHOR WITH SUTURE
K020352 · HWC
Unitedstates Surgical
Orthopedic · 22d
Cleared Feb 26, 2002
MSD WIRE SYSTEM
K020426 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 18d
Cleared Feb 26, 2002
SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE
K020493 · LZA
Syntex Healthcare Products Co., Ltd.
General Hospital · 13d
Cleared Feb 25, 2002
WAVELENGHT ULTRASOUND LOTION
K013212 · MUI
National Therapy Products, Inc.
Radiology · 153d
Cleared Feb 25, 2002
TITANIUM RETROGRADE FEMORAL NAIL - 13 MM DIAMETER
K013923 · HSB
Biomet Orthopedics, Inc.
Orthopedic · 90d
Cleared Feb 25, 2002
AARON REUSABLE ELECTROSURGICAL ELECTRODE
K014201 · GEI
Aaron Medical Industries
General & Plastic Surgery · 66d
Cleared Feb 22, 2002
FABIUS GS ANESTHESIA SYSTEM, MODEL FABIUS GS
K011404 · BSZ
Draeger Medical, Inc.
Anesthesiology · 290d
Cleared Feb 22, 2002
SPIRABRUSH CX BIOPSY INSTRUMENT
K011488 · HFB
Trylon Corp.
Obstetrics & Gynecology · 283d
Cleared Feb 22, 2002
BIOSORBFX O/M 2.0/2/4 SYSTEM
K011569 · JEY
Bionx Implants, Inc.
Dental · 277d
Cleared Feb 22, 2002
BREATHING CIRCUIT FILTER
K012958 · CAH
Emergency Filtration Products, Inc.
General Hospital · 171d
Cleared Feb 22, 2002
BOND-1 C & B
K013543 · KLE
Jeneric/Pentron, Inc.
Dental · 128d
Cleared Feb 22, 2002
TORFLEX TRANSSEPTAL GUIDING SHEATH
K013919 · DBY
Baylis Medical Co., Inc.
Immunology · 87d
Cleared Feb 22, 2002
CP-SLEEVE
K013975 · KXK
Cp Medical
Radiology · 81d
Cleared Feb 22, 2002
NEOCALEX
K013993 · EIK
Stephen M Koral, Dmd
Dental · 80d
Cleared Feb 22, 2002
OPTIBOND SOLO PLUS 4
K014027 · KLE
Kerr Dental Materials Center
Dental · 78d
Cleared Feb 22, 2002
EMORY CARDIAC TOOLBOX 2.1 EXECUTING ON NUCLEAR MEDICINE COMPUTERS
K014033 · KPS
Syntermed, Inc.
Radiology · 77d
Cleared Feb 22, 2002
D.SIGN 84
K014042 · EJS
Ivoclar Vivadent, Inc.
Dental · 77d