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
151513–151536 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 17, 1984
AIMED SCALP VEIN SET VARIOUS
K842255
Tech-Cons Ltd., Intl.
General & Plastic Surgery · 71d
Cleared Aug 17, 1984
AMER. EDWARDS LAB FLEXISCOPE OBTURATOR
K842323 · HRX
American Edwards Laboratories
Orthopedic · 65d
Cleared Aug 17, 1984
SHILEY VENOUS RESERVOIR
K842337 · DTN
Shiley, Inc.
Cardiovascular · 73d
Cleared Aug 17, 1984
MAXIFILL TRANSFER SET
K842345 · LHI
Lyphomed, Inc.
General Hospital · 64d
Cleared Aug 17, 1984
SPX GENERATOR
K842348 · IZO
General Electric Co.
Radiology · 63d
Cleared Aug 17, 1984
HOWMEDICA KINEMATIC II TIBIAL WEDGE
K842367 · HRY
Howmedica Corp.
Orthopedic · 63d
Cleared Aug 17, 1984
ACA CONJUGATED BILIRUBIN ANALYTICAL
K842385 · CIG
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 60d
Cleared Aug 17, 1984
LUSTER, DENTAL POLISHING PASTE
K842403 · EJR
Scientific Pharmaceuticals, Inc.
Dental · 59d
Cleared Aug 17, 1984
ARGYLE ENTERITE ENTERAL FEEDING PUMP
K842421 · FRN
Sherwood Medical Co.
General Hospital · 58d
Cleared Aug 17, 1984
FSH RIA
K842444 · CGJ
Syncor Intl. Corp.
Chemistry · 57d
Cleared Aug 17, 1984
SKIN SCRUB TRAY STERILE SKIN SCRUB KIT
K842490 · FRG
Biological & Environmental Control...
General Hospital · 52d
Cleared Aug 17, 1984
MATRIS INSTRU. VIDEO IMAGER 1010-
K842494 · IZI
Matrix Instruments
Radiology · 52d
Cleared Aug 17, 1984
MATRIX VIDEO IMAGER 1020 COMPACT CAMER
K842495 · IZI
Matrix Instruments
Radiology · 52d
Cleared Aug 17, 1984
SANDARE ACID PHOSPHATASE PROCEDURE
K842516 · CJR
Sandare Chemical Co., Inc.
Chemistry · 38d
Cleared Aug 17, 1984
BLOOD GAS FLUSH SOL. & FLUSH AGENT 1302
K842519 · CHL
Rna Medical Corp.
Chemistry · 38d
Cleared Aug 17, 1984
CDX80
K842536 · BZG
Cdx Corp.
Anesthesiology · 50d
Cleared Aug 17, 1984
COAT-A-COUNT DHEA-SO4 RIA KIT
K842552 · JKC
Diagnostic Products Corp.
Chemistry · 46d
Cleared Aug 17, 1984
AMES TDA PHENOBARBITAL TEST
K842592 · LET
Miles Laboratories, Inc.
Toxicology · 45d
Cleared Aug 17, 1984
COAT-A-COUNT DHEA RIA KIT
K842606 · JKC
Diagnostic Products Corp.
Chemistry · 43d
Cleared Aug 17, 1984
ACCESS. TO INTERAVACULAR ADMIN. SET
K842657 · FPA
Tanner Corp.
General Hospital · 38d
Cleared Aug 17, 1984
SAFRANIN STAIN
K842734 · HZS
E K Ind., Inc.
Pathology · 35d
Cleared Aug 17, 1984
PAP STAIN, OG-6
K842736 · HZJ
E K Ind., Inc.
Pathology · 35d
Cleared Aug 17, 1984
PAP STAIN EA-50
K842738 · HZJ
E K Ind., Inc.
Pathology · 35d
Cleared Aug 17, 1984
DELAFIELD HEMATOXYLIN STAIN
K842740 · HYJ
E K Ind., Inc.
Pathology · 35d