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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
147001–147024 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 16, 1985
ATTENDS DISPOS. UNDERPAD
K853880 · KME
Procter & Gamble Mfg. Co.
General Hospital · 28d
Cleared Oct 16, 1985
OHMEDA OXYGEN BLENDER
K853905 · BZR
Ohmeda Medical
Anesthesiology · 26d
Cleared Oct 16, 1985
LASE SYSTEM II
K853927
James L. Geraci & Associates, Inc.
General & Plastic Surgery · 22d
Cleared Oct 16, 1985
OMNI-TRACT CHEST WALL & LUNA RETRACTOR
K853947 · GAD
Minnesota Scientific, Inc.
General & Plastic Surgery · 22d
Cleared Oct 16, 1985
MINNESOTA SCIENTIFIC, INC. OMNI-BEAM
K853948 · HBI
Minnesota Scientific, Inc.
General & Plastic Surgery · 22d
Cleared Oct 16, 1985
DEMAND ACID PHOSPHATASE REAGENT
K853949 · CKB
Cooper Biomedical, Inc.
Chemistry · 22d
Cleared Oct 16, 1985
WESCOR MODEL 3700 WEBSTER SWEAT INDUCER
K853973 · KTB
Wescor, Inc.
Physical Medicine · 20d
Cleared Oct 16, 1985
CANON X-RAY 35MM CINE CAMERA CSI-35
K853983 · IZJ
Canon USA, Inc.
Radiology · 19d
Cleared Oct 16, 1985
CANON X-RAY IMAGE DISTRIBUTOR
K853984 · JAA
Canon USA, Inc.
Radiology · 19d
Cleared Oct 15, 1985
MEDCYC SUPERCONDUCT ISOCEN NEUTRON THERAPY SYS
K852804 · IWL
Medcyc. Corp.
Radiology · 104d
Cleared Oct 15, 1985
THE FIELDMASTER MODEL 275
K852936 · HPT
Synemed, Inc.
Ophthalmic · 97d
Cleared Oct 15, 1985
COBURN I/A SYSTEM
K853457 · HQE
Coburn Optical Ind., Inc.
Ophthalmic · 60d
Cleared Oct 15, 1985
ORC ORACLE
K853668 · HLQ
Optical Radiation Corp.
Ophthalmic · 42d
Cleared Oct 15, 1985
ZEISS OPERATING KERATOMETER
K853723 · HLQ
Carl Zeiss, Inc.
Ophthalmic · 40d
Cleared Oct 15, 1985
FETAL BOVINE/FETAL CALF SERUM, NEWBORN, HORSE, RAB
K853803 · KIS
Z.L. Bocknek Laboratories, Inc.
Pathology · 34d
Cleared Oct 15, 1985
VISION THEOPHYLLINE
K853834 · KLS
Abbott Laboratories
Toxicology · 29d
Cleared Oct 15, 1985
SUPER MICRO BLADES
K853847
Kdans Surgical, Inc.
General & Plastic Surgery · 29d
Cleared Oct 15, 1985
XTAL X-150 OPERATING MICROSCOPE
K853855 · HRM
Xtal Corp.
General & Plastic Surgery · 29d
Cleared Oct 15, 1985
IL TEST THEOPHYLLINE ASSAY
K853858 · KLS
Allied Instrumentation Laboratory
Toxicology · 29d
Cleared Oct 15, 1985
PANTEX DIRECT TESTOSTERONE COATED TUBE RADIOIMMUNO
K853865 · CDZ
Pantex, Div. Bio-Analysis, Inc.
Chemistry · 28d
Cleared Oct 15, 1985
PANTEX DIRECT ESTRADIOL COATED TUBE RADIOIMMUNOASS
K853866 · CHP
Pantex, Div. Bio-Analysis, Inc.
Chemistry · 28d
Cleared Oct 15, 1985
AMRESCO FLOW PAC CREATININE COLOR REAGENT 2310 &
K853888 · CGX
American Research Products Co.
Chemistry · 26d
Cleared Oct 15, 1985
ALL KINDS OF SUNGLASSES
K853921 · HQY
Winsburn Company , Ltd.
Ophthalmic · 22d
Cleared Oct 15, 1985
TDX AMYLASE
K853978 · CIX
Abbott Laboratories
Chemistry · 19d