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
139993–140016 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 14, 1987
MCBRIDE AGAR, MODIFIED
K871357 · JSJ
Bd Becton Dickinson Vacutainer...
Microbiology · 8d
Cleared Apr 13, 1987
NEUROCHEMICAL ANALYZER
K864729 · LEQ
Esa, Inc.
Chemistry · 130d
Cleared Apr 13, 1987
PAD, PETROLATUM & BISMUTH TRIBROMOPHENATE IMPREG.
K870430 · FRO
Steridyne Laboratories, Inc.
General & Plastic Surgery · 69d
Cleared Apr 13, 1987
AFFINITY DIGOXIN IMMUNIT
K870552 · KXT
Bd Becton Dickinson Vacutainer...
Chemistry · 62d
Cleared Apr 13, 1987
U.S. DIAGNOSTICS LIQUID LD ISOENZYME CONTROL
K870737 · JJT
U. S. Diagnostics, Inc.
Chemistry · 47d
Cleared Apr 13, 1987
U.S. DIAGNOSTICS LIQUID CK ISOENZYME CONTROL
K870738 · JJT
U. S. Diagnostics, Inc.
Chemistry · 47d
Cleared Apr 13, 1987
ELITE ELECTROCARDIOGRAPH
K870920 · LOS
Burdick Corp.
Cardiovascular · 38d
Cleared Apr 13, 1987
SONAFON, THERAPEUTIC MASSAGER
K870972 · IRO
Electro Medica Office
Physical Medicine · 35d
Cleared Apr 13, 1987
LIQUID-STAT IRON REAGENT KIT & TIBC REAGENT KIT
K870986 · JIY
Beckman Instruments, Inc.
Chemistry · 33d
Cleared Apr 13, 1987
OMEGA DORSAL COLUMELLA IMPLANTS
K871071 · FZE
Omega Silicone, Inc.
General & Plastic Surgery · 26d
Cleared Apr 13, 1987
OPN XII UL
K871179 · ILY
Aragona AB Co.
Physical Medicine · 20d
Cleared Apr 13, 1987
PROGESTERONE CLASP RADIOIMMUNOASSAY KIT
K871211 · JLS
Biotecx Laboratories, Inc.
Chemistry · 18d
Cleared Apr 13, 1987
HOOD ESOPHAGEAL PROSTHESIS
K871244 · ESW
Hood Laboratories
Gastroenterology & Urology · 17d
Cleared Apr 13, 1987
CHOLESTEROL DETERMINATION
K871260 · CHH
Biochemical Trade, Inc.
Chemistry · 13d
Cleared Apr 13, 1987
RA SYSTEM, ANALYTE SERUM AMYLASE (30C AND 37C)
K871269 · JFJ
Technicon Instruments Corp.
Chemistry · 13d
Cleared Apr 10, 1987
HIPEC ANALYZER - HA 100 HI-PRO MULTI-ECG ANALYZER
K861505 · DXG
American Medical Equipment, Inc.
Cardiovascular · 352d
Cleared Apr 10, 1987
DOC'S PROPLUGS EAR PLUGS
K862045 · EWD
Doc'S Proplugs, Inc.
Ear, Nose, Throat · 317d
Cleared Apr 10, 1987
DYNATRON 1120 EPS (ELECTRICAL POINT STIMULATOR)
K864370 · GZJ
Dynatronics Laser Corp.
Neurology · 156d
Cleared Apr 10, 1987
POS-T-VAC
K864833 · LKY
Ekc, Inc.
Gastroenterology & Urology · 122d
Cleared Apr 10, 1987
ADVANCED HAND HELD CO2 LASER MODEL HH-550 FOR SU
K864887 · GEX
Bio Quantum Technologies, Inc.
General & Plastic Surgery · 119d
Cleared Apr 10, 1987
MODEL 6110B DENTAPHOR
K870118 · EAT
Life-Tech Intl., Inc.
Dental · 88d
Cleared Apr 10, 1987
FIBRE OPTIC STRIP CHART RECORDER
K870119 · DSF
Apex Imaging Corp.
Cardiovascular · 88d
Cleared Apr 10, 1987
NEUROMAPPER 1620
K870263 · GWQ
Neuroscience, Inc.
Neurology · 77d
Cleared Apr 10, 1987
MODIFIED HR-3000 REUSE ADAPTOR
K870471 · LIF
Colorado Medical, Inc.
Gastroenterology & Urology · 66d