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
164785–164808 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 31, 1981
DADE RH CONTROL REAGENT
K810599 · KSF
American Dade
Hematology · 25d
Cleared Mar 31, 1981
AMPULED FLAME PHOTOMETER STANDARDS
K810618 · JIS
United Diagnostics, Inc.
Radiology · 22d
Cleared Mar 31, 1981
SILICONE ELASTOMER COATED LATEX FOLEY
K810630 · KOD
G.D. Searle and Co.
Gastroenterology & Urology · 22d
Cleared Mar 31, 1981
SERALYZER SYSTEM
K810639 · CGA
Miles Laboratories, Inc.
Chemistry · 21d
Cleared Mar 31, 1981
ORAL AIRWAYS
K810651 · CAE
First Industries, Inc.
Anesthesiology · 21d
Cleared Mar 31, 1981
TUBING CONNECTORS
K810652 · BYX
First Industries, Inc.
Anesthesiology · 21d
Cleared Mar 31, 1981
RPR CARD TEST SYSTEM
K810658 · GMQ
Beckman Instruments, Inc.
Immunology · 20d
Cleared Mar 31, 1981
AUTODILUTER III
K810659 · JTC
Dynatech Corp.
Toxicology · 20d
Cleared Mar 31, 1981
LEECO LH-QUANT DIAGNOSTIC KIT
K810662 · CEP
Leeco Diagnostics, Inc.
Chemistry · 20d
Cleared Mar 31, 1981
ISOLATOR SYSTEM
K810664 · JKA
E.I. Dupont DE Nemours & Co., Inc.
Hematology · 20d
Cleared Mar 31, 1981
AMERLEX ESTRIOL RIA KIT
K810667 · CGI
Amersham Corp.
Chemistry · 19d
Cleared Mar 31, 1981
PANTRAK E.K.
K810669 · CIW
Calbiochem-Behring Corp.
Chemistry · 19d
Cleared Mar 31, 1981
ENZYMATIC CHOLESTEROL
K810673 · CHH
Pointe Scientific, Inc.,
Chemistry · 19d
Cleared Mar 31, 1981
GLUCOSE OXIDASE
K810674 · CGA
Pointe Scientific, Inc.,
Toxicology · 19d
Cleared Mar 31, 1981
ENZYMATIC TRIGLYCERIDE
K810680 · CDT
Pointe Scientific, Inc.,
Chemistry · 18d
Cleared Mar 31, 1981
ESTRIOL RADIOIMMUNOASSAY TEST KIT
K810695 · CHP
Serono Laboratories, Inc.
Chemistry · 15d
Cleared Mar 31, 1981
COAT-A-COUNT T3 UPTAKE KIT
K810717 · KHQ
Diagnostic Products Corp.
Chemistry · 14d
Cleared Mar 31, 1981
C-PEPTICE REAGENTS
K810718 · JKD
Calbiochem-Behring Corp.
Chemistry · 14d
Cleared Mar 31, 1981
CORNING 178 BLOOD GAS ANALYZER
K810724 · CHL
Corning Medical & Scientific
Chemistry · 14d
Cleared Mar 31, 1981
QUALITROL #65057
K810725 · JJT
Harleco
Immunology · 14d
Cleared Mar 31, 1981
AST-UV (PLP-ACTIVATED) DETERMINATION
K810727 · CIT
The Dow Chemical Co.
Chemistry · 14d
Cleared Mar 31, 1981
LUMINESCENCE PHOTOMETER 100 SERIES
K810736 · JJQ
Sai Technology
Chemistry · 13d
Cleared Mar 31, 1981
GOODE MAGNETIC NASAL SPLINT
K810738 · EPP
Xomed, Inc.
Ear, Nose, Throat · 13d
Cleared Mar 31, 1981
LUTEINIZING HORMONE
K810741 · CEP
Pcl-Ria, Inc.
Chemistry · 12d