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
167281–167304 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 30, 1980
MMG DISPOSABLE URINARY LEG BAG
K800694 · KNX
Medical Marketing Group
Gastroenterology & Urology · 64d
Cleared May 30, 1980
FIBRINOGEN SCREEN
K800826 · KQJ
Pacific Hemostasis
Hematology · 46d
Cleared May 30, 1980
MEDESCAN
K800839 · KTA
Medefield Pty. , Ltd.
Radiology · 45d
Cleared May 30, 1980
MEDEBAR M
K800841 · KTA
Medefield Pty. , Ltd.
Radiology · 45d
Cleared May 30, 1980
MEDEBAR XAC-90
K800842 · KTA
Medefield Pty. , Ltd.
Radiology · 45d
Cleared May 30, 1980
MEDEBAR XL
K800844 · KTA
Medefield Pty. , Ltd.
Radiology · 45d
Cleared May 30, 1980
1,3 & 4 WAY STERILE DIS. PLASTIC PKG.
K800862 · FMG
Custom Medical Devices Intl., Inc.
General Hospital · 44d
Cleared May 30, 1980
TANDEM ASSEMBED 3&4 WAY STERILE STOPCKS
K800863 · FMG
Custom Medical Devices Intl., Inc.
General Hospital · 44d
Cleared May 30, 1980
STERILE DISPOS. PLASTIC STOPCOCKS W/TUBE
K800864 · FMG
Custom Medical Devices Intl., Inc.
General Hospital · 44d
Cleared May 30, 1980
WOLFF SYSTEM
K800896 · LEJ
Wolff System GmbH
Radiology · 42d
Cleared May 30, 1980
JOHNLOZ ENDOSCOPY HANDLE
K800915 · KNS
Endoscopic Surgical Accessories, Inc.
Gastroenterology & Urology · 39d
Cleared May 30, 1980
MIDSTREAM COLLECTION KIT
K800947 · FMH
Sage Products, Inc.
General Hospital · 38d
Cleared May 30, 1980
TUBE FEEDING CONTAINER 1500 ML DISPOSE.
K800955 · KNT
The Healthcare Group Laboratories, Inc.
Gastroenterology & Urology · 37d
Cleared May 30, 1980
GAMBRO G SERIES BLOOD LINE SETS FOR HEM.
K801016 · FJK
Gambro, Inc.
Gastroenterology & Urology · 31d
Cleared May 30, 1980
ODOR MASKING AGENT FOR CONTENTS OF ALL
K801025 · FYA
The Buckeye Cellulose Corp.
General Hospital · 32d
Cleared May 30, 1980
TANNING BOOTH/TANS BY TANIQUE
K801034
Dawa Enterprises, Inc.
Radiology · 28d
Cleared May 30, 1980
UNICUF, BLOOD PRESSURE CUFF
K801099 · DXQ
Frontier Products
Cardiovascular · 21d
Cleared May 30, 1980
DOUBLE ENDED FILTERED TRANSFER NEEDLE
K801107 · FMI
Burron Medical Products, Inc.
General Hospital · 21d
Cleared May 30, 1980
DOUBLE ENDED VENTED TRANSFER DEVICE
K801108 · FMI
Burron Medical Products, Inc.
General Hospital · 21d
Cleared May 30, 1980
PROOF (BIOLOGICAL/CHEMICAL INDICATOR)
K801109 · JOJ
Amsco Co.
General Hospital · 18d
Cleared May 30, 1980
MACROVAC
K801127 · JOL
Progress Mankind Technology
General Hospital · 18d
Cleared May 30, 1980
MICROVAC
K801134 · JOL
Progress Mankind Technology
General Hospital · 18d
Cleared May 30, 1980
VOLU-SOL URINARY DICHROME STAIN
K801143 · IDA
Volu Sol Medical Industries
Pathology · 12d
Cleared May 30, 1980
FLOW MED 160
K801179 · FPA
D.R.O. Medical, Inc.
General Hospital · 14d