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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
70201–70224 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 06, 2003
ABBOTT ARCHITECT ESTRADIOL CALIBRATORS
K032458 · JIT
Abbott Laboratories
Chemistry · 56d
Cleared Oct 06, 2003
DIMENSION DRUG CALIBRATOR II, MODEL DC49C
K032574 · DKB
Dade Behring, Inc.
Toxicology · 47d
Cleared Oct 06, 2003
NORMED COMPRESSION BONE SCREW SYSTEM
K032634 · JDS
Noviace Corporation
Orthopedic · 41d
Cleared Oct 06, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFTRIAXONE 0.5-64 UG/ML
K032655 · LON
Becton, Dickinson & CO
Microbiology · 39d
Cleared Oct 06, 2003
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES
K032668 · LYZ
Kingswell International, Inc.
General Hospital · 39d
Cleared Oct 06, 2003
ACE NANCY NAIL
K032687 · HTY
DePuy Orthopaedics, Inc.
Orthopedic · 38d
Cleared Oct 06, 2003
MODIFICATION TO: STELLARTECH COAGULATION SYSTEM (MODELS 1100C-115 & 1100C-230)
K032721 · GEI
Stellartech Research Corp.
General & Plastic Surgery · 33d
Cleared Oct 06, 2003
MODIFICATION TO RENEW LEAD EXTENSION
K032751 · GZB
Advanced Neuromodulation Systems
Neurology · 31d
Cleared Oct 06, 2003
EXTERNAL DRAINAGE SET
K032817 · JXG
Integra Neurosciences Implants S.A.
Neurology · 26d
Cleared Oct 06, 2003
C.T.M. MOBILITY SCOOTER, MODEL HS-235
K032918 · INI
C.T.M. Homecare Product, Inc.
Physical Medicine · 14d
Cleared Oct 03, 2003
REPROCESSED ELECTROPHYSIOLOGY CATHETER
K030279 · NLH
Alliance Medical Corp.
Cardiovascular · 249d
Cleared Oct 03, 2003
EPSILON DURASUL CONSTRAINED ACETABULAR LINER
K030923 · KWZ
Centerpulse Orthopedics, Inc.
Orthopedic · 193d
Cleared Oct 03, 2003
ANS AXXESS PERCUTANEOUS LEAD
K032034 · GZB
Advanced Neuromodulation Systems
Neurology · 94d
Cleared Oct 03, 2003
MEDS-4-INF+
K032055 · GZJ
Medical Equipment Device Specialists
Neurology · 93d
Cleared Oct 03, 2003
SONOSURG SYSTEM
K032066 · LFL
The Olympus Optical Co.
General & Plastic Surgery · 92d
Cleared Oct 03, 2003
GREEN LASER PHOTOCOAGULATOR MODEL GYC-1000
K032085 · GEX
Nidek, Inc.
General & Plastic Surgery · 88d
Cleared Oct 03, 2003
ELAN DIGITAL 12 CHANNEL ELECTROCARDIOGRAPH
K032200 · DPS
Remco Italia S.P.A.
Cardiovascular · 77d
Cleared Oct 03, 2003
MEDX1100 CONSOLE & MEDX 100T AND DUOLIGHT LASER ACCESSORIES, MEDX 100...
K032231 · ILY
Medx Electronics, Inc.
Physical Medicine · 74d
Cleared Oct 03, 2003
PLACER
K032349 · GZB
Advanced Neuromodulation Systems
Neurology · 95d
Cleared Oct 03, 2003
ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221
K032461 · DIC
Lin-Zhi International, Inc.
Toxicology · 53d
Cleared Oct 03, 2003
DISPOSABLE POWDER FREE VINYL EXAM GLOVES
K032630 · LYZ
Kingswell International, Inc.
General Hospital · 38d
Cleared Oct 03, 2003
VIVATIP MICROWAVE ABLATION PROBE
K032702 · GEI
Vivant Medical, Inc.
General & Plastic Surgery · 31d
Cleared Oct 03, 2003
MOSFET AUTOSENSE WIRELESS
K032725 · IYE
Thomson & Nielsen Electronics, Ltd.
Radiology · 30d
Cleared Oct 03, 2003
HEART 2006
K032736 · DXH
Aerotel Medical Systems (1998) , Ltd.
Cardiovascular · 29d