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
166129–166152 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jul 21, 1980
ROLLS ROLLITE WHEELCHAIR
K801557 · IOR
Invacare Corp.
Physical Medicine · 13d
Cleared Jul 21, 1980
CYBREX PHENYTOIN
K801565
Abbott Laboratories
Toxicology · 13d
Cleared Jul 21, 1980
CYBREX PHENOBARBITAL
K801566
Abbott Laboratories
Toxicology · 13d
Cleared Jul 21, 1980
CYBREX THEOPHYLLINE
K801567
Abbott Laboratories
Toxicology · 13d
Cleared Jul 21, 1980
ASH BLUEPRINT ALGINATE IMPRESSION MATER.
K801587 · ELW
Dentsply Intl.
Dental · 10d
Cleared Jul 21, 1980
FIBER OPTIC ILLUMINATOR
K801591 · EAY
Lares Manufacturing Co., Inc.
Dental · 10d