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
167569–167592 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 11, 1980
STERILIZATION PROCESS/VAGINAL SPONGE
K792628 · EFQ
Procter & Gamble Mfg. Co.
General & Plastic Surgery · 23d
Cleared Jan 11, 1980
STERILIZATION PROCESS/T-BINDER
K792629 · KMO
Procter & Gamble Mfg. Co.
General Hospital · 23d
Cleared Jan 11, 1980
STERILIZATION PROCESS/X-RAY DETECT. SPG
K792630 · GDY
Procter & Gamble Mfg. Co.
General & Plastic Surgery · 23d
Cleared Jan 11, 1980
STERILIZATION PROCESS/OUTERWRAP
K792633 · KET
Procter & Gamble Mfg. Co.
Pathology · 23d
Cleared Jan 11, 1980
CENTRIA RADIOIMMUNOASSAY SEPARATION
K792636 · KTS
Union Carbide Corp.
Toxicology · 22d
Cleared Jan 11, 1980
CENTRIA-SET TYPE D(ANTI-SHEEP/GOAT)
K792637 · KTS
Union Carbide Corp.
Toxicology · 22d
Cleared Jan 11, 1980
FLUOROMATIC PHENYTOIN FIA
K792640 · DLP
Bio-Rad
Toxicology · 15d
Cleared Jan 11, 1980
CAM-10 CUIRASS SHELL
K792673 · BYT
Lifecare Services, Inc.
Anesthesiology · 15d
Cleared Jan 11, 1980
IMPLANTABLE BIPOLAR CARDIAC PULSE GEN.
K800030 · DXY
Telectronics, Inc.
Cardiovascular · 4d
Cleared Jan 10, 1980
SCLERAL POWDER
K791923 · HQH
Ocularists , Ltd.
Ophthalmic · 106d
Cleared Jan 10, 1980
MODEL III HANDSWITCH
K792600 · GEI
Sara Dan, Inc.
General & Plastic Surgery · 23d
Cleared Jan 09, 1980
POST EXTRA SYSTOLIC POSTENTLATOR
K791959 · IXO
Medrad, Inc.
Radiology · 100d
Cleared Jan 09, 1980
DYNASOUND 601
K791976 · IMI
Dynawave, Corp.
Physical Medicine · 99d
Cleared Jan 09, 1980
KODAK CFN FILM SO-224
K792178 · IWZ
Eastman Kodak Company
Radiology · 72d
Cleared Jan 09, 1980
KODAK ORTHO G FILM
K792293 · IWZ
Eastman Kodak Company
Radiology · 55d
Cleared Jan 09, 1980
DENTIX DENTAL X-RAY UNIT
K792307 · EAP
Precise Optics
Radiology · 54d
Cleared Jan 09, 1980
SR 301 MEDICAL X-RAY FILM
K792317 · IWZ
E.I. Dupont DE Nemours & Co., Inc.
Radiology · 54d
Cleared Jan 09, 1980
THE CIRCULATOR BOOT
K792354 · DRN
Circulator Boot Corp.
Cardiovascular · 50d
Cleared Jan 09, 1980
SILAGUM
K792363 · ELW
Parkell, Inc.
Dental · 47d
Cleared Jan 09, 1980
TODD HEWITT BROTH
K792423 · JSG
Isle Media and Sterile Products, Inc.
Microbiology · 43d
Cleared Jan 09, 1980
KODAK X-OMAT M20 PROCESSOR, MODEL 2
K792434 · IWZ
Eastman Kodak Company
Radiology · 42d
Cleared Jan 09, 1980
KODAK X-OMAT M20 PROCESSOR, MODEL 1
K792435 · IWZ
Eastman Kodak Company
Radiology · 42d
Cleared Jan 09, 1980
RAFLEX 70
K792437 · EAP
Mdt Corp., Inc.
Radiology · 42d
Cleared Jan 09, 1980
ADR REAL-TIME SECTOR SCANNER
K792446 · IYO
Adr Ultrasound
Radiology · 40d