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
123097–123120 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 27, 1990
NEONATAL VENTILATOR CIRCUIT
K903083 · BZO
Hudson Respiratory Care, Inc.
Anesthesiology · 168d
Cleared Dec 27, 1990
CGA-112 COPING GOLD ALLOY
K903113 · DZE
Minimatic Implant Technology
Dental · 167d
Cleared Dec 27, 1990
ACROMED SACRAL SCREW
K903376 · KWP
Acromed Corp.
Orthopedic · 150d
Cleared Dec 27, 1990
MICRO-MISTER
K903580 · CAF
Bp , Ltd.
Anesthesiology · 141d
Cleared Dec 27, 1990
TEMPORARY DENTAL CEMENT
K904034 · EMA
Medical Device Inspection Co., Inc.
Dental · 118d
Cleared Dec 27, 1990
REFLECTANCE SENSOR (RS-10)
K904039 · DQA
Nellcor, Inc.
Anesthesiology · 114d
Cleared Dec 27, 1990
NEW COBE SATURATION/HEMATOCRIT MONITOR
K904336 · GKF
Cobe Laboratories, Inc.
Hematology · 98d
Cleared Dec 27, 1990
CENTRAL VENOUS PRESSURE MANOMETER
K904674 · KRK
Medex, Inc.
Cardiovascular · 76d
Cleared Dec 27, 1990
THERATEK GROUP EXCHANGE CATHETER
K904680 · MCW
Dow Corning Wright
Cardiovascular · 73d
Cleared Dec 27, 1990
ABUSCREEN ONLINE TM FOR OPIATES
K904997 · DJG
Roche Diagnostic Systems, Inc.
Toxicology · 50d
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