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
150289–150312 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 06, 1985
MEDTRONIC 3465 SE-4F RECEIVER/EXTENSION FOR SPINAL
K844115 · GZB
Medtronic Vascular
Neurology · 106d
Cleared Feb 06, 1985
ARGON/KRYPTON LASER SYSTEM 8500
K844209 · HQB
Cooper Lasersonics, Inc.
Ophthalmic · 98d
Cleared Feb 06, 1985
SPECIMEN COLLECTION & TRANSPORT SYSTEM
K844475 · FMF
Portable Medical Laboratories, Inc.
General Hospital · 79d
Cleared Feb 06, 1985
IMAGEN CHLAMYDIA TEST
K844683 · IWP
Boots-Celltech Diagnostics, Inc.
Microbiology · 68d
Cleared Feb 06, 1985
PARAGON TRICHECK ELECTROPHORESIS CONTROL
K844996 · JJY
Beckman Instruments, Inc.
Chemistry · 42d
Cleared Feb 06, 1985
LEECO PROGESTERONE-QUANT DIAGNOSTIC TEST KIT
K850056 · JLS
Leeco Diagnostics, Inc.
Chemistry · 29d
Cleared Feb 06, 1985
CORNING MAGIC 1-FREE T3 RADIOIMMUNOASSAY
K850140
Corning Medical & Scientific
Chemistry · 23d
Cleared Feb 06, 1985
ACTIVE CORTISOL DSL 2000-SP
K850141 · CGR
Diagnostic Systems Laboratories, Inc.
Chemistry · 23d
Cleared Feb 06, 1985
TDX ETHOSUXIMIDE
K850174 · DLF
Abbott Laboratories
Toxicology · 20d
Cleared Feb 06, 1985
GELMAN TRIPHOR CONTROL
K850202 · JJY
Gelman Sciences, Inc.
Chemistry · 19d
Cleared Feb 06, 1985
CALCIUM
K850281 · CIC
Boehringer Mannheim Corp.
Chemistry · 14d
Cleared Feb 04, 1985
MINUTEMAN CO2 MICROSURGICAL LASER GYN
K843515 · HHR
American Surgical Laser, Inc.
Obstetrics & Gynecology · 152d
Cleared Feb 04, 1985
CANMED 103
K844098 · GXY
Medtronic Vascular
Neurology · 104d
Cleared Feb 04, 1985
PALMER OBSTETIC BRACE
K844183 · KNC
Mic Medical Corp.
Obstetrics & Gynecology · 101d
Cleared Feb 04, 1985
CORNING CALCIUM PH ANALYZER 634
K844188 · JFP
Corning Medical & Scientific
Chemistry · 101d
Cleared Feb 04, 1985
CORDIA IC
K844294 · DAK
Cordis Corp.
Immunology · 90d
Cleared Feb 04, 1985
EGNELL-LACT B BATTERY-OPERATED BREAST PUMP
K844307 · HGX
Egnell, Inc.
Obstetrics & Gynecology · 98d
Cleared Feb 04, 1985
IREX PS, PORTABLE SCANNER AND 118
K844404 · IYO
Irex Corp.
Radiology · 83d
Cleared Feb 04, 1985
SERATEST ENA(RNP/SM) DETERMINATION
K844743 · LLL
Seragen Diagnostics, Inc.
Immunology · 61d
Cleared Feb 04, 1985
VISION TRIGLYCERIDES
K850031 · CDT
Abbott Laboratories
Chemistry · 28d
Cleared Feb 04, 1985
OXYGEN CONCENTRATOR
K850346 · CAW
Inspiron Corp.
Anesthesiology · 7d
Cleared Feb 02, 1985
ARTERIAL EXTENSION SET
K850088 · FPA
Medical Matrix, Inc.
General Hospital · 22d
Cleared Feb 01, 1985
MODIFIED SMEC PERCUTANEOUS INTRA-AORTIC
K840037 · DSP
Smec, Inc.
Cardiovascular · 393d
Cleared Feb 01, 1985
ARRHYTHMIA SYSTEM AC-11
K841084 · DSI
Fukuda Denshi USA, Inc.
Cardiovascular · 325d