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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
166345–166368 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 10, 1980
8-HYDROXYQUINOLINE, CRESOLPHTHALEIN COM.
K802164 · CIC
Panmed, Inc.
Chemistry · 32d
Cleared Oct 10, 1980
MINOCYCLINE 30 MCG. SENSITIVITY DISCS
K802178 · JTN
Difco Laboratories, Inc.
Microbiology · 31d
Cleared Oct 10, 1980
ARTERIAL BLOOD SAMPLING KIT
K802185 · FMP
Current Technologies, Inc.
Hematology · 30d
Cleared Oct 10, 1980
WHITE KNIGHT BOVIE CORD/SUCTION TUBE
K802213 · KKX
G.D. Searle and Co.
General Hospital · 28d
Cleared Oct 10, 1980
ANTERIOR KYPHOSIS DISTRACTION DEVICE
K802222 · KWQ
Zimmer, Inc.
Orthopedic · 28d
Cleared Oct 10, 1980
AIR VIVA II
K802231 · BTM
General Medical Co.
Anesthesiology · 25d
Cleared Oct 10, 1980
GLYCOSYLATED HEMOGLOBIN-SMC COLUMN
K802233 · LCP
Helena Laboratories
Hematology · 25d
Cleared Oct 10, 1980
BEDSIDE TINNITUS MASKER #1500
K802234 · KLW
Marpac, Inc.
Ear, Nose, Throat · 25d
Cleared Oct 10, 1980
7 TRICYCLIC ANTIDE PRESSANTS
K802245 · LFI
Technicon Instruments Corp.
Toxicology · 24d
Cleared Oct 10, 1980
VASCULAR CATHETER WIREGUIDES
K802260 · DQX
Stanco Medical, Inc.
Cardiovascular · 24d
Cleared Oct 10, 1980
KOTEX LIGHTDAYS DEODORANT PANTILINERS
K802277 · HHL
Kimberly-Clark Corp.
Obstetrics & Gynecology · 22d
Cleared Oct 10, 1980
WHITE KNIGHT DRAPE SEAL
K802280 · KKX
G.D. Searle and Co.
General Hospital · 22d
Cleared Oct 10, 1980
ESOPHAGEAL ECG PREAMPLIFIER & SIGNAL CON
K802282 · DRR
Consolidated Medical Equipment, Inc.
Cardiovascular · 21d
Cleared Oct 10, 1980
MLC-4200 CARDIAC OUTPUT COMPUTER
K802305 · DXG
Nihon Kohden America, Inc.
Cardiovascular · 17d
Cleared Oct 10, 1980
WIDEX HEARING AID #'S A18+T & A18+H
K802306 · ESD
Hearing Aid Co.
Ear, Nose, Throat · 17d
Cleared Oct 10, 1980
WIDEX HEARING AID #'S A12+T & A12+H
K802307 · ESD
Hearing Aid Co.
Ear, Nose, Throat · 17d
Cleared Oct 10, 1980
HEMOTEMP TM
K802319 · KSE
Marion Laboratories, Inc.
Hematology · 17d
Cleared Oct 10, 1980
E1 SERIES HEARING AID
K802324 · ESD
Western Advanced Technology, Inc.
Ear, Nose, Throat · 17d
Cleared Oct 10, 1980
PRESSURE MONITORING LINES
K802326 · DRI
Stanco Medical, Inc.
Cardiovascular · 17d
Cleared Oct 10, 1980
SHEATH DILATOR SET
K802327 · DRE
Stanco Medical, Inc.
Cardiovascular · 17d
Cleared Oct 10, 1980
DISP. TOUGY-BORST TYPE ADAPTOR W/PORT
K802328 · DTZ
Stanco Medical, Inc.
Cardiovascular · 17d
Cleared Oct 10, 1980
AO FLEXIBLE LARYNGOSCOPE, #LS-7
K802331 · CAL
American Optical Corp.
Anesthesiology · 17d
Cleared Oct 10, 1980
IN-HOME EARLY PREGNANCY TEST KIT
K802334 · JHJ
Health Diagnostics Corp.
Chemistry · 17d
Cleared Oct 10, 1980
WHIRLPOOL BATHING UNIT-#2001
K802335 · ILJ
Aqua Care Corp.
Physical Medicine · 17d