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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
160513–160536 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 08, 1982
6.5% NACL BROTH
K821596 · JSJ
Hardy Media
Microbiology · 49d
Cleared Jul 08, 1982
BRAIN HEART INFUSION
K821597 · JSC
Hardy Media
Microbiology · 49d
Cleared Jul 08, 1982
MODEL 535-02 TRACE-A-PACE TRANSMITTER
K821726 · DXH
Intermedics, Inc.
Cardiovascular · 27d
Cleared Jul 08, 1982
EGG YOLK AGAR (PLATE)
K821845 · JSF
Granite Diagnostics, Inc.
Microbiology · 16d
Cleared Jul 08, 1982
COAT-A-COUNT INSULIN KIT
K821861 · CFP
Diagnostic Products Corp.
Chemistry · 14d
Cleared Jul 08, 1982
ULTRACHEM E-GLU
K821868 · CFR
Harleco Diagnostics
Chemistry · 13d
Cleared Jul 08, 1982
SUBCLAVIAN
K821929 · FOZ
Dna Medical, Inc.
General Hospital · 9d
Cleared Jul 08, 1982
OMNISURG SIDE MOUNTING CLAMP & RAIL EXT.
K821933 · FWZ
Polamedco, Inc.
General & Plastic Surgery · 9d
Cleared Jul 07, 1982
SONOLINE 3000
K827455
Siemens Medical Solutions USA, Inc.
Radiology · 20d
Cleared Jul 06, 1982
D6ZO DISPOSABLE HEAT EXCHANGER
K813264 · DTR
Electromedics, Inc.
Cardiovascular · 228d
Cleared Jul 06, 1982
FLUID THIOGLYCOLLATE BROTH
K821598 · JSC
Hardy Media
Microbiology · 47d
Cleared Jul 06, 1982
GRAM NEGATIVE BROTH
K821599 · JSJ
Hardy Media
Microbiology · 47d
Cleared Jul 06, 1982
TRYPTIC SOY BROTH
K821600 · JSC
Hardy Media
Microbiology · 47d
Cleared Jul 06, 1982
TRYPTIC SOY AGAR
K821601 · JSC
Hardy Media
Microbiology · 39d
Cleared Jul 06, 1982
THAYER MARTIN
K821602 · JTY
Hardy Media
Microbiology · 39d
Cleared Jul 06, 1982
MYCOBIOTIC AGAR
K821603 · JSJ
Hardy Media
Microbiology · 39d
Cleared Jul 06, 1982
SABOURAUD'S DEXTROSE (SABDEX)
K821604 · JSG
Hardy Media
Microbiology · 39d
Cleared Jul 06, 1982
XYLOSE LYSINE DEOXYCHOLATE AGAR
K821605 · JSI
Hardy Media
Microbiology · 39d
Cleared Jul 06, 1982
BILE ESCULIN AGAR
K821606 · JSF
Hardy Media
Microbiology · 39d
Cleared Jul 06, 1982
MUELLER HINTON W/5% SHEEP'S BLOOD
K821607 · JTZ
Hardy Media
Microbiology · 39d
Cleared Jul 06, 1982
CNA/VAGINALIS AGAR
K821608 · JSI
Hardy Media
Microbiology · 39d
Cleared Jul 06, 1982
VAGAR
K821609 · JSH
Hardy Media
Microbiology · 39d
Cleared Jul 06, 1982
THIOGLYCOLATE WITHOUT INDICATOR
K821610 · JSC
Hardy Media
Microbiology · 39d
Cleared Jul 06, 1982
CLINI-TEK SEMI-AUTOMATED URINALYSIS SYST
K821738 · KQO
Miles Laboratories, Inc.
Chemistry · 22d