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
150841–150864 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 11, 1984
MEDICAL OPTICS PHACOEMULSIFICATION KIT
K844150 · HQC
American Medical Optics
Ophthalmic · 48d
Cleared Dec 11, 1984
THEOPHYLLINE RADIOIMMUNOASSAY ARIA HT SYSTEM
K844170 · KLS
Bd Becton Dickinson Vacutainer...
Toxicology · 47d
Cleared Dec 11, 1984
EMIT QST ETHOSUXIMIDE ASSAY
K844204 · DLF
Syva Co.
Toxicology · 42d
Cleared Dec 11, 1984
AUTOTRACTION TABLE
K844233 · JFB
Chattanooga Group, Inc.
Physical Medicine · 41d
Cleared Dec 11, 1984
COE-LITE POLYMERIZATION UNIT
K844325 · EBZ
Coe Laboratories, Inc.
Dental · 34d
Cleared Dec 11, 1984
OPHTHALMIC CHAIR
K844362 · HMF
Luneau Laboratories
Ophthalmic · 28d
Cleared Dec 11, 1984
O.M.S. GUILLOTINE CUTTER
K844374 · HQE
Optical Micro Systems, Inc.
Ophthalmic · 28d
Cleared Dec 11, 1984
AMERLEX-M SPECIFIC ESTRIOL UNCONJUGATED
K844408 · CGI
Amersham Corp.
Chemistry · 27d
Cleared Dec 11, 1984
TRIGLYCERIDE CALIBRATOR
K844468 · JIT
Sigma Diagnostics, Inc.
Chemistry · 22d
Cleared Dec 11, 1984
OMS SCISSORS
K844510 · HQE
Optical Micro Systems, Inc.
Ophthalmic · 21d
Cleared Dec 11, 1984
MICRA DIAMOND KNIFE MICRA ADJUSTABLE KNIFE
K844553 · HNN
Codman & Shurtleff, Inc.
Ophthalmic · 20d
Cleared Dec 11, 1984
REFERRIL CALIBRATORS
K844585 · JIX
Instrumentation Laboratory CO
Chemistry · 18d
Cleared Dec 11, 1984
IL GENESIS 21, CLINICAL CHEMISTRY ANALYTICAL SYS
K844586 · JJF
Instrumentation Laboratory CO
Chemistry · 18d
Cleared Dec 11, 1984
SIEGEN SURFACE ELECTRODES
K844646 · GXY
Siegen Corp.
Neurology · 12d
Cleared Dec 11, 1984
SPECTABLE FRAME MAGNIFYING BRILLETTE
K844657 · HOJ
Pro Design Intl. AS
Ophthalmic · 12d
Cleared Dec 11, 1984
SPECTABLE FRAME - PRODESIGN SUN CLUB
K844658 · HQZ
Pro Design Intl. AS
Ophthalmic · 12d
Cleared Dec 10, 1984
MECHANICAL SECTOR PROBE 4 MHZ DFM
K842880 · IYO
General Electric Co.
Radiology · 140d
Cleared Dec 10, 1984
STERILE WATER
K843796
Paco Pharmaceutical Services, Inc.
Cardiovascular · 74d
Cleared Dec 10, 1984
ISE REAGENTS FOR DEMAND ANALYZER
K844021 · CGZ
Advanced Biomedical Methods, Inc.
Chemistry · 56d
Cleared Dec 10, 1984
REACTIFS, IBF ULTROGELS ACA & ULTROGELS A
K844164 · DII
Lkb Instruments, Inc.
Chemistry · 46d
Cleared Dec 10, 1984
PHENYTOIN RADIOIMMUNOASSAY USING THE ARIA HT SYSTE
K844171 · LGR
Bd Becton Dickinson Vacutainer...
Chemistry · 46d
Cleared Dec 10, 1984
PTK HEALTHCHECK PREGNANCY TEST KIT
K844281 · LCX
Healthcheck Corp.
Chemistry · 35d
Cleared Dec 10, 1984
ABL300 ACID BASE LABORATORY
K844295 · CHL
Radiometer America, Inc.
Hematology · 34d
Cleared Dec 10, 1984
COAT-A-COUNT ANDROSTENEDIONE RIA KIT
K844398 · CIZ
Diagnostic Products Corp.
Chemistry · 27d