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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
117817–117840 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 11, 1992
TRACE MAGNESIUM - ARSENAZO REAGENT
K920603 · JGJ
Trace America, Inc.
Chemistry · 39d
Cleared Mar 10, 1992
IONGUARD TITANIUM MODULAR HEADS
K915548 · LZY
Biomet, Inc.
Orthopedic · 90d
Cleared Mar 10, 1992
RICH-MAR MODEL 510 ULTRASOUND
K915557 · IMI
Rich-Mar Corp.
Physical Medicine · 90d
Cleared Mar 09, 1992
NEZHAT/DORSEY HYDRO DISSECTION PUMP & ACCESSORIES
K913944 · HET
American Surgical Instruments Corp.
Obstetrics & Gynecology · 187d
Cleared Mar 09, 1992
ROOT CANAL FILLING CEMENT
K914325 · KIF
Confi-Dental Products Co.
Dental · 165d
Cleared Mar 09, 1992
ASEPTIC DENTAL TECH. TOTAL TREATMENT SYSTEM
K914562 · DZM
Aseptic Dental Technologies, Inc.
Dental · 146d
Cleared Mar 09, 1992
CORDIS STRAIGHT VENTRICULAR CATHETER
K914995 · JXG
Cordis Corp.
Neurology · 123d
Cleared Mar 09, 1992
LAPAROSCOPY SCISSORS
K915544 · GCJ
C.R. Bard, Inc.
General & Plastic Surgery · 89d
Cleared Mar 09, 1992
DIAGNOSTIC EP CATHETER
K915563 · DRF
Arrhythmia Technologies, Inc.
Cardiovascular · 88d
Cleared Mar 09, 1992
VOYAGR SERIES OF DEFLECTABLE DIAGOSTIC EP CATHETER
K915640 · DRF
Arrhythmia Technologies, Inc.
Cardiovascular · 83d
Cleared Mar 09, 1992
MER BAG
K915810 · BTM
Merced Medical, Inc.
Anesthesiology · 76d
Cleared Mar 09, 1992
GYMMAN
K920099 · DRT
Lumiscope Co., Inc.
Cardiovascular · 60d
Cleared Mar 06, 1992
TAMPON, UNTREATED
K912941 · HEB
Hygieia Healthcare , Ltd.
Obstetrics & Gynecology · 249d
Cleared Mar 06, 1992
SUCTION CONTROL FOOTSWITCH WITH SPEED CONTROL
K913401 · HRX
Smith & Nephew Dyonics, Inc.
Orthopedic · 220d
Cleared Mar 06, 1992
ENDOTRACHEAL SUCTIONTUBE
K913876 · JOL
Willowtech
General Hospital · 190d
Cleared Mar 06, 1992
JAIN BLOOD SHIELD
K913896 · JOL
Jain Surgical Equipment, Inc.
General Hospital · 189d
Cleared Mar 06, 1992
OMNITRON GYN APPLICATOR SYSTEM
K913908 · JAQ
Omnitron Intl., Inc.
Radiology · 189d
Cleared Mar 06, 1992
SAECG CARDIOGRAPH MODEL M1754A
K913997 · KNT
Hewlett-Packard Co.
Gastroenterology & Urology · 182d
Cleared Mar 06, 1992
NON-WEIGHTED POLYURETHANE ENTERAL FEEDING TUBE
K914375 · KNT
Sherwood Medical Co.
Gastroenterology & Urology · 157d
Cleared Mar 06, 1992
VORTECH 3M NETWORK PRINTING
K914834 · LMC
Vortech Data, Inc.
Radiology · 133d
Cleared Mar 06, 1992
CHEMO PRIMING PIN(TM)
K914924 · FPA
Block Medical, Inc.
General Hospital · 123d
Cleared Mar 06, 1992
CONBIO MEDLITE Q-SWITCHED ND:YAG LASER SYSTEM
K915497 · GEX
Continuum Biomedical, Inc.
General & Plastic Surgery · 88d
Cleared Mar 06, 1992
FLO-GARD 8000 HALF-SET
K915499 · FRN
Baxter Healthcare Corp
General Hospital · 88d
Cleared Mar 06, 1992
GAMBRO LUNDIA ALPHA HEMODIALYZERS
K915504 · FJG
C.G.H. Medical, Inc.
Gastroenterology & Urology · 88d