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
156193–156216 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 18, 1983
OMNIPROBE ELECTRICAL NERVE STIMULATOR
K831147 · GZJ
Omni Intl., Inc.
Neurology · 101d
Cleared Jul 18, 1983
ARTHROSCOPY INFUSION SYS..VALVE
K831218 · HRX
Acufex Microsurgical, Inc.
Orthopedic · 94d
Cleared Jul 18, 1983
ANTI-ENA TEST
K831292 · LKO
Meloy Laboratories, Inc.
Immunology · 89d
Cleared Jul 18, 1983
MSI-NAK-50 TEST KIT
K831300 · JGM
Medical Specialties, Inc.
Chemistry · 88d
Cleared Jul 18, 1983
DIFFERENTIA/DIAGNOSTIC OCCLUSA/APPLIANC
K831344
Brimms, Inc.
Dental · 84d
Cleared Jul 18, 1983
CELL-DYN 400 HEMOTOLOGY ANALYZER
K831368 · GKL
Abbott Diagnostics
Hematology · 83d
Cleared Jul 18, 1983
CURAY-ECLIPSE VISIBLE LIGHT CURED ORTHO
K831495 · DYH
Scientific Pharmaceuticals, Inc.
Dental · 69d
Cleared Jul 18, 1983
NEPHROLYTE
K831502 · KFC
Flaitron Laboratories, Inc.
Pathology · 68d
Cleared Jul 18, 1983
SPINAL FLUID TOTAL PROTEIN CONTROL
K831527 · JJX
Quantimetrix Corp.
Chemistry · 67d
Cleared Jul 18, 1983
FLUORETS STERILE OPHTH. STRIPS
K831621 · KYC
Smith & Nephew, Inc.
Ophthalmic · 60d
Cleared Jul 18, 1983
WAKO R-GTP C-TEST
K831639 · JPZ
Wako Chemicals USA, Inc.
Chemistry · 56d
Cleared Jul 18, 1983
HYPER-HYPOTHERMIA UNIT HYPO 10-200
K831677 · DWC
Gambro, Inc.
Cardiovascular · 56d
Cleared Jul 18, 1983
WAKO CHOLESTEROL CII
K831687 · CHH
Wako Chemicals USA, Inc.
Pathology · 55d
Cleared Jul 18, 1983
WM. HARVEY PARALLEL PLATE MEMBRANE BLOOD
K831705 · DTZ
C.R. Bard, Inc.
Cardiovascular · 53d
Cleared Jul 18, 1983
MONOJET SPS BLOOD COLLECTION TUBE
K831719 · JKA
Sherwood Medical Co.
Chemistry · 48d
Cleared Jul 18, 1983
PERCUTANEOUS CATHETER INSERTION TRAY
K831729 · DQY
American Pharmaseal Div. Ahsc
Cardiovascular · 48d
Cleared Jul 18, 1983
CONTINUOUS FLUSH DEVICE
K831730 · KRA
American Pharmaseal Div. Ahsc
Cardiovascular · 48d
Cleared Jul 18, 1983
INFANT EVALUATION CARRIER
K831731 · FPP
E.M. Adams
General Hospital · 48d
Cleared Jul 18, 1983
QUANTIMUNE HFSH RIA HUMAN FOLLICLE-
K831742 · CGJ
Bio-Rad
Chemistry · 48d
Cleared Jul 18, 1983
LOGIPE A DATA REDUCSYSTEM IP SPECIFIC-
K831774 · DGO
Diagnostic Reagent Tech.
Immunology · 46d
Cleared Jul 18, 1983
PLASTIC DISPOSABLE RAZOR
K831799 · LDQ
I M, Inc.
General & Plastic Surgery · 45d
Cleared Jul 18, 1983
CATHETER INSERTION TRAYS, VARIOUS #'S
K831807 · DQY
American Pharmaseal Div. Ahsc
Cardiovascular · 42d
Cleared Jul 18, 1983
ADRENOCORTICOTROPIN RADIO-IMMUNOASSAY
K831826 · CKG
Damon Corp.
Microbiology · 41d
Cleared Jul 18, 1983
STAINLESS STEEL GUIDE WIRE
K831839 · DQX
Quinton, Inc.
Cardiovascular · 41d