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
146881–146904 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 29, 1985
FLUORESCENT T12 UVA TANNING LAMP
K854004 · FTC
Light Sources, Inc.
General & Plastic Surgery · 29d
Cleared Oct 29, 1985
SELECT FLOWMETER
K854067 · CAX
Precision Medical, Inc.
Anesthesiology · 25d
Cleared Oct 28, 1985
MEVAPLAN AND SOMADOS
K852410 · KPQ
Siemens Medical Solutions USA, Inc.
Radiology · 144d
Cleared Oct 28, 1985
VICKERS ERGOMATIC MICROS INSTR-LONG R OR L HANDED
K853180 · GZX
Keeler Instruments, Inc.
Neurology · 90d
Cleared Oct 28, 1985
VICKERS ERGOMATIC MICROS INSTR-FINE R OR L HANDED
K853181 · GZX
Keeler Instruments, Inc.
Neurology · 90d
Cleared Oct 28, 1985
VARIAN XIMATRON C-SERIES RADIOTHERAPY TREATMENT ST
K853349 · KPQ
Varian Assoc., Inc.
Radiology · 77d
Cleared Oct 28, 1985
WAVE GATE
K853412 · GWE
Wolfline Corp.
Neurology · 76d
Cleared Oct 28, 1985
SIGMA 610 FOR PROTEIN IN URINE & CSF
K853681 · CEK
Sigma Diagnostics, Inc.
Chemistry · 54d
Cleared Oct 28, 1985
ASTRA SYSTEMS CHOLESTEROL REAGENT
K853854 · CHH
Beckman Instruments, Inc.
Chemistry · 42d
Cleared Oct 28, 1985
TDX AMPHETAMINE METHAMPHETAMINE
K853879 · DKZ
Abbott Laboratories
Chemistry · 40d
Cleared Oct 28, 1985
UNIVERSAL STAND FOR FILM CHANGER
K853928 · KPX
Canon USA, Inc.
Radiology · 34d
Cleared Oct 28, 1985
HITACHI 704
K854025 · JJE
Boehringer Mannheim Corp.
Chemistry · 28d
Cleared Oct 28, 1985
LASER ASO KIT
K854039 · GTQ
Behring Diagnostics, Inc.
Microbiology · 26d
Cleared Oct 28, 1985
TDX BARBITURATES
K854044 · LGQ
Abbott Laboratories
Toxicology · 26d
Cleared Oct 28, 1985
OMNI PLANE SYSTEM
K854085 · IXR
Xre Corp.
Radiology · 21d
Cleared Oct 28, 1985
THE CSE FILM CHANGER SYSTEM
K854251 · IZP
Changer Service & Engineering, Inc.
Radiology · 6d
Cleared Oct 25, 1985
LACTOPLATE
K852737 · DEG
Mackeen Consultants, Ltd.
Immunology · 120d
Cleared Oct 25, 1985
ENDO-LASE CD-100 CO2 LASER FOR EXTERNAL GENITALIA-
K853874 · GEX
Endo Lase, Inc.
General & Plastic Surgery · 38d
Cleared Oct 25, 1985
ENDO-LASE CD40 FOR UROLOGY
K853904 · GEX
Endo Lase, Inc.
General & Plastic Surgery · 35d
Cleared Oct 25, 1985
MICROVASIVE SILICONE SPRAY
K854063 · KCT
Microvasive
General Hospital · 21d
Cleared Oct 25, 1985
NML TSH IRMA
K854087 · JLW
Organon Teknika Corp.
Chemistry · 18d
Cleared Oct 25, 1985
DMA CALIBRATORS
K854092 · JIX
Data Medical Associates, Inc.
Chemistry · 18d
Cleared Oct 25, 1985
ACCURACY
K854119 · JJY
Columbia Diagnostics, Inc.
Chemistry · 16d
Cleared Oct 24, 1985
DIAGNOSTIC ECG DISPOSABLE ELECTRODE
K851522 · DRX
Sentry Medical Products, Inc.
Cardiovascular · 192d