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
151729–151752 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 15, 1984
LIVER BIOPSY TRAY
K842001
Jayco Pharmaceuticals
Gastroenterology & Urology · 152d
Cleared Oct 15, 1984
STERILE DESIGN-CUSTOM STERILE IV KIT
K842351 · FPA
Sterile Design, Inc.
General Hospital · 122d
Cleared Oct 15, 1984
GLYCO-TEK AFFINITY COLUMN
K842689 · LCP
Helena Laboratories
Hematology · 97d
Cleared Oct 15, 1984
SAFE & SOFT MINI PADS & MAXI PADS
K842836 · HHD
Ipco Corp.
Obstetrics & Gynecology · 87d
Cleared Oct 15, 1984
SAFE & SOFT MAXI SHILEDS
K842837 · HHD
Ipco Corp.
Obstetrics & Gynecology · 87d
Cleared Oct 15, 1984
HOLLOW BASKET DENTAL IMPLANTS
K843217 · DZE
Artech Corp.
Dental · 61d
Cleared Oct 15, 1984
LAURIER SANITARY NAPKIN
K843318 · HHD
Kao Corp.
Obstetrics & Gynecology · 52d
Cleared Oct 15, 1984
RIA PANTY SHIELDS
K843401 · HHD
Paul Hartmann Corp.
Obstetrics & Gynecology · 46d
Cleared Oct 13, 1984
PERCUTANEOUS BALLOON
K832753 · DSP
Smec, Inc.
Cardiovascular · 425d
Cleared Oct 12, 1984
INTRAUTERINE DEVICE REMOVER
K842295 · HHF
Premier Dental Products Co.
Obstetrics & Gynecology · 123d
Cleared Oct 12, 1984
MICROSPAN -PH MONITOR
K842303 · CBF
Biochem International, Inc.
Anesthesiology · 123d
Cleared Oct 12, 1984
ACT, SUCTION TIP
K842779 · BSY
Edward Manougian, M.D.
Anesthesiology · 88d
Cleared Oct 12, 1984
BEMCO PORTABLE OXYGEN INHALATOR
K843585 · CAN
Bemco, Inc.
Anesthesiology · 31d
Cleared Oct 12, 1984
A-T TENS BELT
K843793 · GZJ
A-T Surgical Mfg. Co., Inc.
Neurology · 28d
Cleared Oct 12, 1984
N2 TEST
K843840
Erich Jaeger, Inc.
Cardiovascular · 11d
Cleared Oct 12, 1984
CO2 TEST
K843844 · CCK
Erich Jaeger, Inc.
Anesthesiology · 11d
Cleared Oct 12, 1984
CO TEST
K843845 · CCJ
Erich Jaeger, Inc.
Anesthesiology · 11d
Cleared Oct 12, 1984
O2 TEST
K843847 · CCL
Erich Jaeger, Inc.
Anesthesiology · 11d
Cleared Oct 11, 1984
DIAGEM DIGITAL BLOOD GLUCOSE MONITOR
K841648 · JJQ
Forward Medical Supplies
Chemistry · 174d
Cleared Oct 11, 1984
GASTRIN RADIOIMMUNOASSAY TEST KIT
K842965
Serono Diagnostics, Inc.
Chemistry · 76d
Cleared Oct 11, 1984
RENIN RADIOIMMUNOASSAY TEST KIT
K842966 · CIB
Serono Diagnostics, Inc.
Chemistry · 76d
Cleared Oct 11, 1984
ATAC 2000
K843059 · JJE
Turpen Laboratory Systems, Inc.
Chemistry · 69d
Cleared Oct 11, 1984
TUGS-TRANSPORTABLE UNIV. GRADIENT SUCT
K843081 · JCX
Creative Medical Laboratories, Inc.
General & Plastic Surgery · 66d
Cleared Oct 11, 1984
GREEN CROSS URINARY DRAINAGE BAG
K843117 · KNX
Tech-Cons Ltd., Intl.
Gastroenterology & Urology · 64d