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

Filters: Cleared only ×
176,076 results
166969–166992 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 21, 1980
ALBUMIN NEPHELOMETRIC ASSAY
K801362 · JQX
J.T. Baker Chemical Co.
Chemistry · 42d
Cleared Jul 21, 1980
A2 IMAGE PROCESSING SYSTEM
K801368 · IYX
Medtronic Vascular
Radiology · 41d
Cleared Jul 21, 1980
GF-120-L DIALYZER
K801370 · FJI
Gambro, Inc.
Gastroenterology & Urology · 41d
Cleared Jul 21, 1980
K1 POTASSIUM ACETATE ADDITIVE
K801385 · FKT
Organon Teknika Corp.
Gastroenterology & Urology · 38d
Cleared Jul 21, 1980
HEMOHLOBIN A2 CONTROL-LYOPHILIZED
K801410 · JPD
Isolab, Inc.
Hematology · 35d
Cleared Jul 21, 1980
MAY ILLUMINATED/INFUSION PIC
K801411 · HMX
Cooper Medical Devices Corp.
Ophthalmic · 35d
Cleared Jul 21, 1980
KEELER AMOILS ACULL CRYO OPHTHALMIC UNIT
K801418 · HPS
Keeler Optical Products , Ltd.
Ophthalmic · 34d
Cleared Jul 21, 1980
ESTRIOL RIA KIT FOR USE WITH GAMMAFLO
K801424 · CGI
Squibb & Sons, Inc.
Toxicology · 34d
Cleared Jul 21, 1980
MODEL 5100 ELECTROCHEMICAL DETECTOR
K801439 · LEQ
Environmental Sciences Assoc., Inc.
Toxicology · 31d
Cleared Jul 21, 1980
SORB 10 DIALYSATE INFUSATE C1 INFUSATE
K801440 · FKT
Organon Teknika Corp.
Gastroenterology & Urology · 31d
Cleared Jul 21, 1980
OTICON MODEL E17P EARETTE HEARING AID
K801448 · ESD
Oticon Corp.
Ear, Nose, Throat · 28d
Cleared Jul 21, 1980
BLOOD GAS CONTROL PROD. NO. BG-1, BG-2
K801449 · JJS
Health Diagnostics Corp.
Chemistry · 28d
Cleared Jul 21, 1980
OJ-1 ENDODONIC ROOT CANAL FILE HOLDER
K801463 · EKQ
Almore Intl., Inc.
Dental · 27d
Cleared Jul 21, 1980
HYDRON ROOT CANAL FILLING MATERIAL
K801482 · KIF
National Patent Development Corp.
Dental · 66d
Cleared Jul 21, 1980
MARK IV SYRINGE
K801483 · EIC
National Patent Development Corp.
Dental · 66d
Cleared Jul 21, 1980
ROOT CANAL FILLING APPLICATOR NEEDLES
K801484 · EIC
National Patent Development Corp.
Dental · 66d
Cleared Jul 21, 1980
CARDIO-PULMONARY EXERCISE STRESS SYSTEM
K801495 · BZM
Medical Graphics Corp.
Anesthesiology · 25d
Cleared Jul 21, 1980
PULMONARY LAB AUTOMATION SYSTEM
K801496 · BZM
Medical Graphics Corp.
Anesthesiology · 25d
Cleared Jul 21, 1980
ZEST PLANT
K801524 · DZE
Zest Anchors, Inc.
Dental · 20d
Cleared Jul 21, 1980
ZEST ENDODONTIC STABILIZER
K801525 · ELS
Zest Anchors, Inc.
Dental · 20d
Cleared Jul 21, 1980
SURVEYOR I, RESPIRATORY COMPUTER SYSTEM
K801526 · BZC
The Devilbiss Co.
Anesthesiology · 19d
Cleared Jul 21, 1980
ARM SLING
K801531 · ILI
The Owenby Co.
Physical Medicine · 20d
Cleared Jul 21, 1980
PERF-LOCK IMPRESSION TRAY
K801548 · EHY
Dentsply Intl.
Dental · 14d
Cleared Jul 21, 1980
ARGYLE SAF-T-MARK SUCTION CATHETER
K801551 · BSY
Sherwood Medical Co.
Anesthesiology · 13d