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

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176,076 results
157009–157032 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 19, 1983
RENAK
K831694 · CIB
Hoffmann-La Roche, Inc.
Chemistry · 56d
Cleared Jul 19, 1983
MULTICHEM ENZYMATIC CHOLESTEROL SYS
K831700 · CHH
Simmler, Inc.
Chemistry · 56d
Cleared Jul 19, 1983
TRICYCLIC ANTIDEPRESSNATS VI
K831737 · DIF
Utak Laboratories, Inc.
Toxicology · 49d
Cleared Jul 19, 1983
TRANSCUTANEOUS OXYGEN MONITOR OPTION
K831744 · KLK
Ge Medical Systems Information...
Anesthesiology · 49d
Cleared Jul 19, 1983
FLOW-CALIBRATION MODULE
K831758 · BXW
The Perkin-Elmer Corp.
Anesthesiology · 48d
Cleared Jul 19, 1983
HEMOSTATS
K831797 · HRQ
I M, Inc.
General & Plastic Surgery · 46d
Cleared Jul 19, 1983
DISPOSABLE SCALPELS
K831798 · KDC
I M, Inc.
General & Plastic Surgery · 46d
Cleared Jul 19, 1983
NEURO-PULSER 2 TRANSCUTAN. ELEC. NERVE
K831850 · GZJ
Th Charters, Inc.
Neurology · 40d
Cleared Jul 19, 1983
SCOLIMETER
K831898 · KTZ
Dr. Micheal A. Sabia
Orthopedic · 35d
Cleared Jul 19, 1983
FLUORESCEIN CONJUGATED IMMUNOGLOBULIN
K831903 · DES
Dako Corp.
Immunology · 35d
Cleared Jul 19, 1983
RABBIT ANTISERUM TO HUMAN KAPPA LIGHT
K831904 · DEO
Dako Corp.
Immunology · 35d
Cleared Jul 19, 1983
RABBIT ANTISERUM TO HUMAN C4
K831906 · DBI
Dako Corp.
Immunology · 35d
Cleared Jul 19, 1983
RABBIT ANTISERUM TO HUMAN IGM
K831907 · DFS
Dako Corp.
Immunology · 35d
Cleared Jul 19, 1983
PLASTIC TUBING CONNECTORS
K831920 · BYY
Polymer Technology Corp.
General Hospital · 35d
Cleared Jul 19, 1983
THEOPHYLLINE ACA CALIBRATOR
K831933 · DLJ
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 34d
Cleared Jul 19, 1983
TALL FLOOR STAND TFS-01
K831939 · GCX
Sorensen Research
General Hospital · 33d
Cleared Jul 19, 1983
INFUSION PUMP
K831953 · FIR
Cryosan, Inc.
Gastroenterology & Urology · 34d
Cleared Jul 19, 1983
RADIAL IMMUNO-TEST FOR HUMAN C-REACTI
K831958 · DCK
Kent Laboratories, Inc.
Chemistry · 32d
Cleared Jul 19, 1983
RADIAL IMMUNO-TEST FOR HUMAN FACTOR B
K831959 · JZH
Kent Laboratories, Inc.
Chemistry · 32d
Cleared Jul 19, 1983
TEST FOR HUMAN ALPHA ONE ACID GLYCO-
K831960 · LKL
Kent Laboratories, Inc.
Chemistry · 32d
Cleared Jul 19, 1983
EMIT SERUM TRICYCLIC ANTIDEPRESS. CONTRO
K831979 · LAS
Syva Co.
Toxicology · 29d
Cleared Jul 19, 1983
EMIT SERUM TRICYCLIC ANTIDEPRESS CALIBRA
K831980 · DLJ
Syva Co.
Toxicology · 29d
Cleared Jul 19, 1983
ASTRA SYSTEMS ENZYME MODULE LD-P
K832048 · CFJ
Beckman Instruments, Inc.
Chemistry · 25d
Cleared Jul 19, 1983
USE 77 ULTRASONIC NEBULIZER
K832086 · CAF
Medlog GmbH Marketing Services
Anesthesiology · 21d