FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
165289–165312 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Oct 31, 1980
VIRAL TRANSPORT MED. (46-995-04)
K802303 · JSM
Flow Laboratories, Inc.
Microbiology · 38d
Cleared Oct 31, 1980
COMFORT CUSHION DRY BURN PADS, STERILE
K802317 · KKX
American Convertors Div., American...
General Hospital · 38d
Cleared Oct 31, 1980
COULTER DACOS SERUM CHEM. ANALYZER
K802320 · JJE
Coulter Electronics, Inc.
Chemistry · 38d
Cleared Oct 31, 1980
PHADEBACT PNEUMOCOCCUS TEST
K802337 · GWC
Pharmacia, Inc.
Microbiology · 35d
Cleared Oct 31, 1980
DISP. FENESTRATED SURG. DRAPE SHEETS
K802359 · KKX
American Convertors Div., American...
General Hospital · 35d
Cleared Oct 31, 1980
UTERINE VACUM ASPIRATING CURRETTE
K802360 · HHI
American Hospital Supply Corp.
Obstetrics & Gynecology · 35d