FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
156169–156192 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jul 19, 1983
EXTERNAL INCONTINENCE CATHETER TRAVEL
K832106 · KNX
Plasco, Inc.
Gastroenterology & Urology · 20d
Cleared Jul 19, 1983
LEG BAG EXTENTION TUBE-STERILE
K832107 · KNX
Plasco, Inc.
Gastroenterology & Urology · 20d
Cleared Jul 19, 1983
MONOBLOCK PROSTOPERATIVE TENS ELECTRODE
K832145 · GXY
New Dimensions IN Medicine, Inc.
Neurology · 14d
Cleared Jul 18, 1983
WEDGE PRESSURE CATHETER
K830604 · DYG
Plasmedics, Inc.
Cardiovascular · 143d
Cleared Jul 18, 1983
APNEA/BRADYCARDIA MONITOR HB 95
K830666 · DPS
Harvey-Bostwick, Inc.
Cardiovascular · 136d
Cleared Jul 18, 1983
HSV IGM TEST
K830865 · GQL
Gull Laboratories, Inc.
Microbiology · 122d