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
166129–166152 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 31, 1980
PACEPATH MODEL 810
K801416 · DTB
Pacesetter Systems
Cardiovascular · 137d
Cleared Oct 31, 1980
THERMOCOMP
K801553 · IYM
Hospital Financial Corp.
Radiology · 115d
Cleared Oct 31, 1980
HOLLO FIBER DIALYZER
K801559 · FJI
Renal Devices, Inc.
Gastroenterology & Urology · 115d
Cleared Oct 31, 1980
DEPALMA ELBOW
K801574 · JDB
Zimmer, Inc.
Orthopedic · 114d
Cleared Oct 31, 1980
ANDROSTENEDIONE RADIOIMMUNOASSAY KIT
K801729 · CIZ
Diagnostics Biochem Canada, Inc.
Chemistry · 99d
Cleared Oct 31, 1980
FERTILITY AWARENESS METHOD KIT
K801791 · FLK
Telesis Corp.
General Hospital · 94d
Cleared Oct 31, 1980
PLASTIC STRIP BANDAGES
K801837 · FPX
Martin'S Maine Exchange
General & Plastic Surgery · 91d
Cleared Oct 31, 1980
ICA1 IONIZED CALCIUM ANALYZER
K801848 · JFP
The London Co.
Chemistry · 88d
Cleared Oct 31, 1980
GCS-79
K801921 · GEH
Gilmore Liquid Air Co.
General & Plastic Surgery · 87d
Cleared Oct 31, 1980
FLOWCLAMP CAT.#1011 & 1012
K802009 · FKK
Pollak (Intl.), Ltd.
Gastroenterology & Urology · 72d
Cleared Oct 31, 1980
INFUSSION ALARM SYSTEM I.A.S. CAT.#1118
K802011 · FLN
Pollak (Intl.), Ltd.
General Hospital · 72d
Cleared Oct 31, 1980
CYBREX LIDOCAINE
K802131 · KLR
Abbott Laboratories
Toxicology · 57d
Cleared Oct 31, 1980
CHEEK EPIDURAL SCREW
K802137 · GWM
Codman & Shurtleff, Inc.
Neurology · 57d
Cleared Oct 31, 1980
CHEEK TOOL SET
K802138 · GWM
Codman & Shurtleff, Inc.
Neurology · 57d
Cleared Oct 31, 1980
SPATULA, CERVICAL CYTOLOGICAL CYTOLOGY
K802139 · HHT
Dyn-A-Med Products
Obstetrics & Gynecology · 57d
Cleared Oct 31, 1980
KODAK ORTHO L FILM
K802171 · IWZ
Eastman Kodak Company
Radiology · 52d
Cleared Oct 31, 1980
GOAT ANTI-HUMAN IGM
K802177 · DFT
Protos Laboratories
Immunology · 52d
Cleared Oct 31, 1980
WISCONSIN HEART RATE MONITOR
K802182 · DRT
Lunar Radiation Corp.
Cardiovascular · 52d
Cleared Oct 31, 1980
GOAT ANTI-HUMAN COMPLEMENT C4
K802196 · DBI
Protos Laboratories
Immunology · 51d
Cleared Oct 31, 1980
GOAT ANTI-HUMAN IGG GAMMA CHAIN SPECIFIC
K802257 · DEW
Protos Laboratories
Immunology · 45d
Cleared Oct 31, 1980
MINIVISOR TERMINAL
K802263 · IYO
Organon Teknika Corp.
Radiology · 45d
Cleared Oct 31, 1980
WASH SOLUTION KIT, #88102
K802264 · JJF
Hi Chem, Inc.
Chemistry · 45d
Cleared Oct 31, 1980
FLUORESCENT SUN LAMP FIXTURE
K802291 · HJE
Strato-Ray Co.
General & Plastic Surgery · 42d
Cleared Oct 31, 1980
POLYFLEX IMPLANTABLE PACING LEAD
K802293 · DTB
Intermedics, Inc.
Cardiovascular · 42d