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
142225–142248 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 29, 1986
COAGULATOR (8 CHANNEL)
K862047 · KQG
Med USA
Hematology · 123d
Cleared Sep 29, 1986
OLYMPUS AU 5000 FLAME PHOTOMETER MODULE
K862148 · JJO
Olympus Corp.
Chemistry · 117d
Cleared Sep 29, 1986
MONOFLUOR CHLAMYDIA TRACHOMATIS DIR SPEC TEST KIT
K862354 · LJP
Synbiotics Corp.
Microbiology · 101d
Cleared Sep 29, 1986
AMYLASE SR LIQUID STABLE REAGENT SET
K862733 · JFJ
Medical Analysis Systems, Inc.
Chemistry · 73d
Cleared Sep 29, 1986
PATHFINDER(TM) RESPIRATORY SYNCYTIAL VIRUS
K862743 · GQG
Kallestad Laboratories, Inc.
Microbiology · 70d
Cleared Sep 29, 1986
ANGIOMED VAC-U-CUT BIOPSY NEEDLE
K862805 · GDM
Angiomed U.S., Inc.
General & Plastic Surgery · 69d
Cleared Sep 29, 1986
GAMBRO LUNDIA 10-1L, 1N, 1H, 3H, 4N, 4H, 5H, 6N
K862840 · FJG
Gambro, Inc.
Gastroenterology & Urology · 62d
Cleared Sep 29, 1986
BARD WILLIAM HARVEY CARDIOTOMY RESERVOIR
K862920 · DTN
C.R. Bard, Inc.
Cardiovascular · 59d
Cleared Sep 29, 1986
F-11 REFLECTOR / F-II STANDARD REFLECTOR
K863019 · EAZ
Sds Dental, Inc.
Dental · 52d
Cleared Sep 29, 1986
PROGRAMMER MODEL 2035/ELECTROGRAM CABLE MODEL 6580
K863045 · KRG
Cardiac Pacemakers, Inc.
Cardiovascular · 48d
Cleared Sep 29, 1986
PREGNASLIDE
K863198 · JHJ
Armkel, LLC
Chemistry · 41d
Cleared Sep 29, 1986
PROLACTIN RIABEAD II DIAGNOSTIC KIT
K863240 · CFT
Abbott Laboratories
Chemistry · 38d
Cleared Sep 29, 1986
CHOLESTEROL PROCEDURE
K863252 · CHH
Data Medical Associates, Inc.
Chemistry · 35d
Cleared Sep 29, 1986
TOTAL PROTEIN PROCEDURE
K863258 · CEK
Data Medical Associates, Inc.
Chemistry · 35d
Cleared Sep 29, 1986
ALKALINE PHOSPHATASE PROCEDURE
K863268 · CJE
Data Medical Associates, Inc.
Chemistry · 35d
Cleared Sep 29, 1986
URIC ACID (URICASE) METHOD-II
K863287 · JHC
Catachem, Inc.
Chemistry · 35d
Cleared Sep 29, 1986
ATAC 4300 HEMATOLOGY CELL COUNTER
K863332 · GKL
Turpen Laboratory Systems, Inc.
Hematology · 33d
Cleared Sep 29, 1986
AVL ISE-TROL ELECTROLYTE CONTROL
K863333 · JJR
Avl Scientific Corp.
Chemistry · 32d
Cleared Sep 29, 1986
CORDIPAK CARDIAC CATHETERIZATION PACK
K863337 · DQO
Angi-Pak Corp.
Cardiovascular · 32d
Cleared Sep 29, 1986
BOUFFANT-STYLE SURGICAL CAP
K863359 · FYF
Kimberly-Clark Corp.
General & Plastic Surgery · 27d
Cleared Sep 29, 1986
QUANTIMETRIX DRUG FREE SERUM CONTROL
K863388 · DIF
Quantimetrix Corp.
Toxicology · 26d
Cleared Sep 29, 1986
PHENYTOIN, AS PERFORMED ON TECHNICON RA SYSTEMS
K863403 · DIP
Technicon Instruments Corp.
Toxicology · 26d
Cleared Sep 29, 1986
KUNDIN WOUND GAUGE
K863409 · FTY
Jane I. Kundin
General & Plastic Surgery · 26d
Cleared Sep 29, 1986
EMDS(TM) ALCOHOL TESTPACKS, #67691/95
K863419 · DML
Em Diagnostic Systems, Inc.
Toxicology · 26d