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
165409–165432 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 23, 1980
VIEW-LITE, MODEL-SL
K802217 · IXC
Med-Western Electronics, Inc.
Radiology · 41d
Cleared Oct 23, 1980
SD-900 OSCILLOMETRIC BP MONITOR
K802218 · DXN
Industrial & Biomedical Sensors Corp.
Cardiovascular · 41d
Cleared Oct 23, 1980
ANALYTE T3 UPTAKE
K802246 · KHQ
Technicon Instruments Corp.
Chemistry · 37d
Cleared Oct 23, 1980
SP 120 SOPHISTICATE
K802251 · JQP
Vickers America Medical Corp.
Chemistry · 37d
Cleared Oct 23, 1980
TRIGLYCERIDES DETERMINATION
K802256 · CDT
Coleman Laboratories Corp.
Chemistry · 37d
Cleared Oct 23, 1980
TRANSVENOUS PACEMAKER ELECTRODE KIT
K802259 · LDF
Stanco Medical, Inc.
Cardiovascular · 37d
Cleared Oct 23, 1980
HGB3 (1:251)
K802266 · GKR
R&D Systems, Inc.
Hematology · 37d
Cleared Oct 23, 1980
THE IMMOBILIZER FOR OPEN & ARTHROSCOPIC
K802271 · BWN
The Anspach Effort, Inc.
General & Plastic Surgery · 36d
Cleared Oct 23, 1980
FTA-ABS BIOPAK
K802276 · JWL
Bioware Products
Microbiology · 35d
Cleared Oct 23, 1980
ANTISERA TO HUMAN FREE KAPPA CHAINS
K802283 · DFH
Kallestad Laboratories, Inc.
Immunology · 34d
Cleared Oct 23, 1980
ANTISERA TO HUMAN FREE LAMBDA LIGHT CH.
K802284 · CZQ
Kallestad Laboratories, Inc.
Immunology · 34d
Cleared Oct 23, 1980
ARGLE LATEX PENROSE TUBING
K802286 · KGZ
Sherwood Medical Co.
General & Plastic Surgery · 34d
Cleared Oct 23, 1980
VIVONEX JEJUNOSTOMY KIT
K802300 · KNT
Norwich Eaton Pharmaceuticals, Inc.
Gastroenterology & Urology · 31d
Cleared Oct 23, 1980
CORDIS DOW INFUSION PUMP
K802301 · FRN
Cordis Corp.
General Hospital · 31d
Cleared Oct 23, 1980
IL TOTAL PROTEIN REAGENT
K802310 · CEK
Instrumentation Laboratory CO
Chemistry · 30d
Cleared Oct 23, 1980
MO8 OXYGEN FLOWMETER
K802311 · CAX
Timeter Instrument Corp.
Anesthesiology · 30d
Cleared Oct 23, 1980
ARGYLE SILICONE THORACIC CATHETER
K802318 · GBS
Sherwood Medical Co.
General & Plastic Surgery · 30d
Cleared Oct 23, 1980
CRITERION II PACING SYSTEM MONITORS
K802325 · DRT
Dart Medical Equipment
Cardiovascular · 30d
Cleared Oct 23, 1980
ATTENU-CHEK
K802350 · EWO
Hear Co., Inc.
Ear, Nose, Throat · 28d
Cleared Oct 23, 1980
OHIO RADIANT WARMER
K802365 · FMT
Ohio Medical Products
General Hospital · 24d
Cleared Oct 23, 1980
ARROW CATHETER CLAMP
K802367 · KGZ
Arrow Intl., Inc.
General & Plastic Surgery · 24d
Cleared Oct 23, 1980
URIC ACID/ALDH
K802371 · CDO
Boehringer Mannheim Corp.
Chemistry · 24d
Cleared Oct 23, 1980
KODAK EKTA-CHEM CLINICAL CHEM. SLIDES
K802376 · CHS
Eastman Kodak Company
Chemistry · 23d
Cleared Oct 23, 1980
ASTRA PRINTER PAPER #88112-CHLORIDE SILV
K802392 · JJF
Hi Chem, Inc.
Chemistry · 21d