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
148681–148704 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 06, 1985
ESTRADIOL DIRECT RIA KIT
K851540 · CHP
Biotecx Laboratories, Inc.
Chemistry · 51d
Cleared Jun 06, 1985
TODAY PERSONAL LUBRICANT
K851617 · KMJ
Vli Corp.
General Hospital · 49d
Cleared Jun 06, 1985
ACCULEVEL THEOPHYLLINE TEST(MODIFICATION)
K851741 · KLS
Syva Co.
Toxicology · 38d
Cleared Jun 06, 1985
MANIFOLD CLAMPS
K852118 · DTL
Omser Sv., Inc.
Cardiovascular · 22d
Cleared Jun 05, 1985
K-MESH
K843829
Katecho, Inc.
General & Plastic Surgery · 247d
Cleared Jun 05, 1985
SYSTEM 920 ARGON/DYE PHOTOCOAGULATOR
K844357 · HQF
Coherent Medical Group
Ophthalmic · 208d
Cleared Jun 05, 1985
PENNINE NELATON CATHETERS SIZES 5,6,8,10,12,14,16,
K844876 · GBX
Pennine Medical , Ltd.
General & Plastic Surgery · 170d
Cleared Jun 05, 1985
J & J ULCER DRESSING
K850451 · FRO
Johnson & Johnson Professionals, Inc.
General & Plastic Surgery · 119d
Cleared Jun 05, 1985
MITRATHANE DRESSING
K850535 · NAD
Mitral Medical , Ltd.
General & Plastic Surgery · 114d
Cleared Jun 05, 1985
INHALATION THERAPY NEBULIZER DEVICE
K850711 · KFZ
Med USA
Anesthesiology · 103d
Cleared Jun 05, 1985
TREDBAND TYPE I, IT, II & III - TREADMILLS
K850871 · BXB
Ketronic, Inc.
Physical Medicine · 96d
Cleared Jun 05, 1985
HEARING AID, UNITRON MODEL UC
K850914 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 92d
Cleared Jun 05, 1985
CHEST CATHETERS/THORACIC CATHETERS
K851048 · GBS
Medovations, Inc.
General & Plastic Surgery · 83d
Cleared Jun 05, 1985
BODY TYPE HEARING AID 107S
K851069 · ESD
Danavox, Inc.
Ear, Nose, Throat · 79d
Cleared Jun 05, 1985
PHACO PAK I
K851211 · HQC
United Sonics, Inc.
Ophthalmic · 71d
Cleared Jun 05, 1985
RADIAL IMMUNODIFFUSION PLATES C3 & C4
K851286 · CZW
Cooper Biomedical, Inc.
Immunology · 65d
Cleared Jun 05, 1985
RDIOGRAPHIC WALL HOLDER OR FILM RECEPTOR
K851440 · IXY
Summit Industries, Inc.
Radiology · 56d
Cleared Jun 05, 1985
LASER RF CONTROL SERUM-QUALITY CONTROL SERUM
K851537 · DHR
Behring Diagnostics, Inc.
Immunology · 50d
Cleared Jun 05, 1985
IMPACT TURBO CATH
K851611 · JOL
Impact Instrumentation, Inc.
General Hospital · 57d
Cleared Jun 05, 1985
APO A-I IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN A1
K851649 · DER
Photec Diagnostics, Inc.
Immunology · 44d
Cleared Jun 05, 1985
DIGITAL GAMMA CAMERA GCA 501S
K851686 · JWM
Toshiba Medical Systems
Radiology · 43d
Cleared Jun 05, 1985
JUMBO DIGITAL GAMMACAMERA GCA-90B
K851687 · JWM
Toshiba Medical Systems
Radiology · 43d
Cleared Jun 05, 1985
ULTRA-NEB 100 ULTRASONIC NEBULIZER
K851695
The Devilbiss Co.
Cardiovascular · 44d
Cleared Jun 05, 1985
DIGITAL SUBTRACTION ANTIOGRAPHY PHANTOM 76-700/711
K851812 · IXF
Victoreen, Inc.
Radiology · 40d