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

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175,820 results
140713–140736 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 01, 1987
TDCONTROL LIQUID MULTI-ANALYTE THERAPEUTIC DRUG
K870586 · DIF
Medical Analysis Systems, Inc.
Toxicology · 49d
Cleared Apr 01, 1987
ACA HUMAN CHORIONIC GONADOTROPIN (HCG) METHOD
K870672 · JHI
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 41d
Cleared Apr 01, 1987
FRESENIUS HEMOFLOW F60 AND F80
K870724 · KDI
Seratronics, Inc.
Gastroenterology & Urology · 36d
Cleared Apr 01, 1987
SOFT TISSUE BIOPSY NEEDLE
K870785 · KNW
Bd Becton Dickinson Vacutainer...
Gastroenterology & Urology · 34d
Cleared Apr 01, 1987
REFLECTIVE MIRROR/CO2 LASER SURG CAT. #902002-000
K870790 · FTX
Lifestream Int'L, Inc.
General & Plastic Surgery · 34d
Cleared Apr 01, 1987
MACBICK-XL BASIC AIR CONTAST BARIUM ENEMA DELIV SY
K870796 · FCE
Plasco, Inc.
Gastroenterology & Urology · 33d
Cleared Apr 01, 1987
CIBA CORNING/SHIMADZU MODEL 580 CLINI. CHEM. ANALY
K870833 · JJE
Ciba Corning Diagnostics Corp.
Chemistry · 29d
Cleared Apr 01, 1987
ATAC 1500 CHEMISTRY ANALYZER
K870836 · JJE
Turpen Laboratory Systems, Inc.
Chemistry · 29d
Cleared Apr 01, 1987
SIMPULSE ARTHROSCOPY IRRIGATION SYSTEM
K870915 · HRX
C.R. Bard, Inc.
Orthopedic · 26d
Cleared Apr 01, 1987
DIGOXIN FPIA REAGENT SET
K870951 · KXT
Sigma Diagnostics, Inc.
Toxicology · 22d
Cleared Apr 01, 1987
PHARMASEAL T TYPE THERMOCOUPLE 100% CATH./PROBE
K870977 · KOD
American Pharmaseal Div. Ahsc
Gastroenterology & Urology · 22d
Cleared Apr 01, 1987
SENSITESTER
K871167 · GWY
Dexin Pty. , Ltd.
Neurology · 8d
Cleared Apr 01, 1987
LUBRICATING JELLY
K871169 · KMJ
H & P Industries, Inc.
General Hospital · 8d
Cleared Mar 31, 1987
CARY BLAIR TRANSPORT MEDIUM
K864237 · JSM
Mds Laboratories, Inc.
Microbiology · 154d
Cleared Mar 31, 1987
CHOCOLATE AGAR
K864238 · KZI
Mds Laboratories, Inc.
Microbiology · 154d
Cleared Mar 31, 1987
CLED AGAR WITH ANDRADES INDICATOR
K864239 · JSH
Mds Laboratories, Inc.
Microbiology · 154d
Cleared Mar 31, 1987
COLUMBIA BLOOD AGAR WITH 5% SHEEP BLOOD
K864240 · JSG
Mds Laboratories, Inc.
Microbiology · 154d
Cleared Mar 31, 1987
DNASE AGAR
K864241 · JSF
Mds Laboratories, Inc.
Microbiology · 154d
Cleared Mar 31, 1987
HEKTOEN ENTERIC AGAR
K864242 · JSI
Mds Laboratories, Inc.
Microbiology · 154d
Cleared Mar 31, 1987
MACCONKEY AGAR
K864243 · JSI
Mds Laboratories, Inc.
Microbiology · 154d
Cleared Mar 31, 1987
GARNERELLA VAGINALIS IDENTIFICATION KIT
K864244 · JTO
Mds Laboratories, Inc.
Microbiology · 154d
Cleared Mar 31, 1987
MUELLER HINTON AGAR SMALL
K864245 · JTZ
Mds Laboratories, Inc.
Microbiology · 154d
Cleared Mar 31, 1987
MUELLER HINTON AGAR LARGE
K864246 · JTZ
Mds Laboratories, Inc.
Microbiology · 154d
Cleared Mar 31, 1987
MUELLER HINTON AGAR WITH 5% SHEEP BLOOD
K864247 · JTZ
Mds Laboratories, Inc.
Microbiology · 154d