FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
123697–123720 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 27, 1990
ADULT,STERILE,DISPOS.,NONIVAS.,BLOOD PRESS. CUFFS
K905147 · DXQ
Hewlett-Packard Co.
Cardiovascular · 42d
Cleared Dec 27, 1990
THE BRACKET ASSEMBLY WITH A SECURITY SYSTEM
K905197 · EJT
Ormco Corp.
Dental · 37d
Cleared Dec 27, 1990
MAGNESIUM REAGENT
K905544 · JGJ
Amresco, Inc.
Chemistry · 16d
Cleared Dec 27, 1990
AFFINITY FSH TEST SYSTEM
K905592 · CGJ
Bd Becton Dickinson Vacutainer...
Chemistry · 14d
Cleared Dec 27, 1990
POWERED VENTILATOR, LEVER I/II, BATTLEFIELD USE
K905697 · BTL
Impact Instrumentation, Inc.
Anesthesiology · 3d
Cleared Dec 26, 1990
DCL - SYPHILIS-G ASSAY CATALOG NO. 600-70
K895965 · LIP
Diagnostic Chemicals, Ltd. (Usa)
Microbiology · 441d
Cleared Dec 26, 1990
G.E. DXS 350/550/650/650II SINGLE PHASE GENERATORS
K902987 · IZO
Electromek Diagnostic Systems, Inc.
Radiology · 183d
Cleared Dec 26, 1990
A-1101 CAST ABUTMENT
K903039 · DZE
Minimatic Implant Technology
Dental · 168d
Cleared Dec 26, 1990
CHOLESTAT(TM) WHOLE BLOOD CHOLESTEROL TEST
K903126 · CHH
Crystal Diagnostics, Inc.
Chemistry · 163d
Cleared Dec 26, 1990
STATPAL BLOOD GAS MONITORING SYSTEM
K903965 · CHL
Ppg Industries, Inc.
Chemistry · 120d
Cleared Dec 26, 1990
GLUCOMETER QA BLOOD GLUCOSE METER AND GLUCOFILM
K904081 · CGA
Heraeus Kulzer, Inc.
Chemistry · 112d
Cleared Dec 26, 1990
CHOLESTECH LIPID MONITORING SYSTEM, GLUCOSE TEST
K904082 · CGA
Cholestech Corp.
Chemistry · 112d
Cleared Dec 26, 1990
CAPTIA(R) SYPHILIS M, MODIFICATION
K904524 · LIP
Mercia Diagnostics , Ltd.
Microbiology · 90d
Cleared Dec 26, 1990
EMIT(R) II CANNABINOID 100 NG ASSAY
K904568 · LDJ
Syva Co.
Toxicology · 78d
Cleared Dec 26, 1990
EMIT(R) II 9 CANNABINOID NEGATIVE CALIBRA/CONTROLS
K904569 · DLJ
Syva Co.
Toxicology · 78d
Cleared Dec 26, 1990
EMIT(R) II CANNABINOID 20 NG ASSAY
K904570 · LDJ
Syva Co.
Toxicology · 78d
Cleared Dec 26, 1990
EMIT(R) II CANNABINOID 50 NG ASSAY
K904571 · LDJ
Syva Co.
Toxicology · 78d
Cleared Dec 26, 1990
I/A-PHACO SYSTEM (IRR./ASPIR./AND PHACO./SYSTEM)
K904612 · HQC
Medical Technical Products
Ophthalmic · 76d
Cleared Dec 26, 1990
ACS CHOLESTREROL/TRIGLYCERIDE LIQUID LINEAR CALIBR
K904767 · JIX
Analytical Control Systems, Inc.
Chemistry · 65d
Cleared Dec 26, 1990
GLYC-AFFIN GP
K904814 · LCP
Isolab, Inc.
Chemistry · 63d
Cleared Dec 26, 1990
CEDARS-SINAI QUANTITATIVE TI-201 ANALYSIS CTQ 2.0
K905222 · LLZ
Nuccardiac Software, Inc.
Radiology · 36d
Cleared Dec 26, 1990
CHOLESTECH LIPID MONITORING SYSTEM,HDL CHOLESTEROL
K905296 · LBS
Cholestech Corp.
Chemistry · 29d
Cleared Dec 26, 1990
CHEM-CHEX LIPID
K905389 · JJY
Streck Laboratories, Inc.
Chemistry · 26d
Cleared Dec 26, 1990
CEDIA(R) THEOPHYLLINE ASSAY/MODIFICATION
K905521 · LER
Microgenics Corp.
Toxicology · 19d