Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
142825–142848 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Sep 29, 1986
NOVA II SODIUM/POTASSIUM/LITHIUM ANALYZER
K863438 · JJP
Nova Biomedical Corp.
Chemistry · 24d
Cleared Sep 29, 1986
STRYKER ORTHOPOWER 90 & ORTHOPOWER 90 SYSTEM II
K863447 · GET
Stryker Corp.
General & Plastic Surgery · 21d
Cleared Sep 29, 1986
POTASSIUM TEST
K863486 · CEJ
Sclavo, Inc.
Chemistry · 20d
Cleared Sep 29, 1986
PARAMAX ELECTROLYTE CALIBRATOR
K863489 · JIX
American Dade
Chemistry · 20d
Cleared Sep 29, 1986
BICONDYLAR TOE PROSTHESIS
K863528
Depuy, Inc.
Orthopedic · 19d
Cleared Sep 29, 1986
EASY-TEST CARBON DIOXIDE (CO2) ITEM #67649/95
K863544 · KHS
Em Diagnostic Systems, Inc.
Chemistry · 17d
Cleared Sep 29, 1986
URESIL STD FLAT/ROUND & FLAT/ROUND SPLIT. SILI/DRA
K863560 · GBS
Uresil Corp.
General & Plastic Surgery · 17d
Cleared Sep 29, 1986
URESIL 150CC BELLOWS RESERVOIR
K863562 · GCY
Uresil Corp.
General & Plastic Surgery · 17d
Cleared Sep 29, 1986
LE VEEN WOUND SPLINT
K863570 · KGS
Tek-Aid, Inc.
General & Plastic Surgery · 17d
Cleared Sep 29, 1986
AMYLASE PROCEDURE
K863588 · JFJ
Data Medical Associates, Inc.
Chemistry · 14d