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
165505–165528 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Oct 10, 1980
TORQUE CONTROL BALLOON CATHETER
K802338 · DYG
Cordis Corp.
Cardiovascular · 14d
Cleared Oct 10, 1980
SPECIMEN SET
K802340 · FMH
American Pharmaseal Div. Ahsc
General Hospital · 14d
Cleared Oct 10, 1980
PREGNA B-ANTI HUMAN CHORIONIC GONADOTRO
K802343 · JHJ
Intl. Diagnostic, Inc.
Chemistry · 14d
Cleared Oct 10, 1980
OREIA-Q-DIG
K802358 · KXT
Organon, Inc.
Toxicology · 14d
Cleared Oct 10, 1980
ALGINATE IMPRESSION MATERIAL
K802362 · ELW
Dentsply Intl.
Dental · 14d
Cleared Oct 10, 1980
NU-BORN BABY BATH KIT
K802366 · LDQ
American Hospital Supply Corp.
General & Plastic Surgery · 11d