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
161881–161904 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 16, 1981
DIAGNOSTIC MEDICAL COMPUTER
K812638 · DXG
Diagnostic Resources, Inc.
Cardiovascular · 62d
Cleared Nov 16, 1981
LIFESPAN CO2
K812643 · CCK
Biochem International, Inc.
Anesthesiology · 61d
Cleared Nov 16, 1981
SKI 5000
K812646 · DXK
Smithkline Diagnostics, Inc.
Cardiovascular · 60d
Cleared Nov 16, 1981
SILICONE IMPLANTS
K812691 · MDM
Sutter Biomedical, Inc.
General & Plastic Surgery · 55d
Cleared Nov 16, 1981
MILLER/NADLER GLARE TESTER
K812706 · HOS
Mosebach Electric & Supply
Ophthalmic · 53d
Cleared Nov 16, 1981
MODEL 5867-12 BIPOLAR LOW-PROFILE LEAD
K812725 · LDF
Medtronic Vascular
Cardiovascular · 49d
Cleared Nov 16, 1981
BOUNDARY PROCESS CHANGE
K812738 · KKX
The Buckeye Cellulose Corp.
General Hospital · 48d
Cleared Nov 16, 1981
FETAL VITABILITY TM MODE
K812743 · IYO
Technicare Corp.
Radiology · 48d
Cleared Nov 16, 1981
MODEL 535-03 TRACE A PACE
K812755 · DXH
Intermedics, Inc.
Cardiovascular · 47d
Cleared Nov 16, 1981
DATASCRIBE #DS-40
K812765 · BXW
Timeter Instrument Corp.
Anesthesiology · 42d
Cleared Nov 16, 1981
VANCE-AMBROSE RESECTOSCOPE FORCEPS
K812785 · GEN
Vance Products, Inc.
General & Plastic Surgery · 42d
Cleared Nov 16, 1981
RIND AIRWAY
K812822 · CAE
Rind Medical Development
Anesthesiology · 39d
Cleared Nov 16, 1981
ORBIC* SPHERICAL ALLOY
K812827 · EJJ
Johnson & Johnson Professionals, Inc.
Dental · 39d
Cleared Nov 16, 1981
MODEL 2000 MONITOR
K812828 · DRT
Datascope Corp.
Cardiovascular · 39d
Cleared Nov 16, 1981
SURGICAL SUCTION INSTRUMENTS-DISPOS.
K812845 · GCX
Abco Dealers, Inc.
General Hospital · 38d
Cleared Nov 16, 1981
MEDICON #8200 AMS
K812873 · BZQ
Medicon, Inc.
Anesthesiology · 33d
Cleared Nov 16, 1981
ENDODONTIC PAPER POINTS
K812886 · EKN
United Dental Mfg., Inc.
Dental · 33d
Cleared Nov 16, 1981
HEMASITE GRAFTLESS VASCULAR ACESS
K812890 · FIQ
Renal Systems, Inc.
Gastroenterology & Urology · 32d
Cleared Nov 16, 1981
FOGARTY FLEXIBLE PROBE
K812935 · DWP
American Edwards Laboratories
Cardiovascular · 27d
Cleared Nov 16, 1981
MILLAR MIKRO-TIP CATHETER PRESSURE TRAN.
K812944 · DRF
Millar Instruments, Inc.
Cardiovascular · 27d
Cleared Nov 16, 1981
EAST VENTILARM PRESSURE MONITOR ALARM S.
K812960 · CAP
Cairco , Ltd.
Anesthesiology · 26d
Cleared Nov 16, 1981
INTRODUCER, PERCUTANEOUS SELDINGER
K812964 · DYB
Triad Medical Division
Cardiovascular · 25d
Cleared Nov 16, 1981
PERCUTANEOUS INTRODUCER COURNAND STYLE
K812973 · DYB
Dip, Inc.
Cardiovascular · 24d
Cleared Nov 16, 1981
LANCER COAGENT HUMAN FACTOR 1X PLASMA
K812974 · GGP
Sherwood Medical Co.
Hematology · 24d