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
173905–173928 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 14, 1977
HYPODERMIC SYRINGE
K771205 · FMF
Terumo America, Inc.
General Hospital · 9d
Cleared Jul 14, 1977
TERUFUSION DONOR SET
K771207 · FMI
Terumo America, Inc.
General Hospital · 9d
Cleared Jul 14, 1977
DOPPLER (UTD-5 & UTD-6)
K771211 · HEK
Terumo America, Inc.
Obstetrics & Gynecology · 9d
Cleared Jul 14, 1977
GRAY TONE IMAGING FILM
K771223 · IWZ
Eastman Kodak Company
Radiology · 9d
Cleared Jul 13, 1977
ELECTRO-SURGICAL DEVICES
K771009 · GEI
Deseret Pharmaceutical Co.
General & Plastic Surgery · 40d
Cleared Jul 13, 1977
INTRODUCER, CAT. #INT-06FR.
K771041 · DYB
Sorensen Research
Cardiovascular · 34d
Cleared Jul 13, 1977
INTRODUCER, CAT. #INT-05FR.
K771042 · DYB
Sorensen Research
Cardiovascular · 34d
Cleared Jul 12, 1977
TRIGLYCERIDE KIT
K771068 · JGM
Environmental Chemical Specialties
Chemistry · 29d
Cleared Jul 11, 1977
THROMBO SCREEN QUANTITATIVE HEPARIN ASSA
K770722 · JBR
Bay Area Hema. Onco. Clinic. & Res. L
Hematology · 83d
Cleared Jul 11, 1977
TABLE, TREATMENT, THERAPY, PHYSICAL
K770723 · INT
Chattanooga Pharmacal Co.
Physical Medicine · 83d
Cleared Jul 11, 1977
TRACTION DEVICES, INTERMITTENT, TX
K770724 · IRS
Chattanooga Pharmacal Co.
Physical Medicine · 83d
Cleared Jul 11, 1977
PUMP, INFUSION, DYNATECH/HANDLEY
K770730 · FRN
Dynatech Medical Products
General Hospital · 82d
Cleared Jul 11, 1977
PIPETTE, DISPENSING, MODEL ADP-30SD
K770772 · JQW
G.D. Searle and Co.
Chemistry · 74d
Cleared Jul 11, 1977
PIPETTE, DILUTING, MODEL ADP-30SD
K770773 · JQW
G.D. Searle and Co.
Chemistry · 74d
Cleared Jul 11, 1977
LYTETEK SYSTEM
K770774 · JGT
Boehringer Mannheim Corp.
Chemistry · 74d
Cleared Jul 11, 1977
REAGENTS
K770780 · CHH
Chemetrics Corp.
Chemistry · 73d
Cleared Jul 11, 1977
SHAVE PREP SET
K770795 · JJX
Lukens Corp.
Chemistry · 70d
Cleared Jul 11, 1977
TRAY, CATHETERIZATION W/FOLEY, STERILE
K770797 · FRG
Lukens Corp.
General Hospital · 70d
Cleared Jul 11, 1977
ULTRAZYME PLUS GT
K770815
Harleco
Chemistry · 68d
Cleared Jul 11, 1977
ULTRACHEM ALBUMIN
K770816 · CIX
Harleco
Chemistry · 68d
Cleared Jul 11, 1977
ULTRACHEM CALCIUM
K770817 · CJY
Harleco
Chemistry · 68d
Cleared Jul 11, 1977
ULTRAZYME PLUS, LDH
K770818 · CFJ
Harleco
Chemistry · 68d
Cleared Jul 11, 1977
ULTRACHEM CREATININE
K770819 · CGX
Harleco
Chemistry · 68d
Cleared Jul 11, 1977
ULTRACHEM INORGANIC PHOSPHORUS
K770820 · CEO
Harleco
Chemistry · 68d