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

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175,820 results
123817–123840 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 17, 1990
CATH LAB AUTOMATED INTERACTIVE RECORDER SYSTEMS
K900814 · DQK
Intellimetrics Instrument Corp.
Cardiovascular · 299d
Cleared Dec 17, 1990
SARNS DELPHIN CENTRIFUGAL SYSTEM W/DIRECTION. FLOW
K902404 · KFM
3M Company
Cardiovascular · 201d
Cleared Dec 17, 1990
COBE CARDIOTOMY RESERVOIR WITH OR WITHOUT FILTER
K902437 · DTP
Cobe Laboratories, Inc.
Cardiovascular · 196d
Cleared Dec 17, 1990
COBE ICU CONVERSION KIT
K902631 · DTN
Cobe Laboratories, Inc.
Cardiovascular · 186d
Cleared Dec 17, 1990
COMFORTRON II (TENS)
K902948 · LWM
M. D. Products
Dental · 165d
Cleared Dec 17, 1990
SCREW-VENT ENDOSSEOUS HA COATED DENTAL IMPLANTS
K902969 · DZE
Core-Vent Corp.
Dental · 164d
Cleared Dec 17, 1990
LUPO-TEST REAGENT
K903037 · GIR
Gradipore , Ltd.
Hematology · 159d
Cleared Dec 17, 1990
HASSON STABILIZING ACCESS CANNULA
K903078 · HET
Marlo Surgical Technology
Obstetrics & Gynecology · 158d
Cleared Dec 17, 1990
HOLLOW LUMEN NEEDLE, PART NUMBER: MX920
K903199 · DQO
Medex, Inc.
Cardiovascular · 150d
Cleared Dec 17, 1990
MAXI-FLOW INSUFFLATOR TUBING SET
K903208 · HES
Adler Instrument Co.
Obstetrics & Gynecology · 150d
Cleared Dec 17, 1990
YOUNG PROPHY SYSTEM, PS UNIT
K903284 · KOJ
Young Dental Manufacturing Co. 1, LLC
Dental · 148d
Cleared Dec 17, 1990
ALPHA-FILL, ALPHA-CEM, AND ALPHA-SILVER
K903481 · EBF
Dental Foremost
Dental · 137d
Cleared Dec 17, 1990
MONITRODE
K903491 · DRX
Lleventon
Cardiovascular · 136d
Cleared Dec 17, 1990
SALTER LABS MODEL #1015
K903539 · CBH
Salter Labs
Anesthesiology · 132d
Cleared Dec 17, 1990
INTERSEPT 1375 VENOUS RESERVOIR
K903632 · DTN
Medtronic Vascular
Cardiovascular · 129d
Cleared Dec 17, 1990
CMV IGM ELISA TEST
K903807 · LFZ
Gull Laboratories, Inc.
Microbiology · 119d
Cleared Dec 17, 1990
ARGENCO 26B
K903971 · EJS
Argen Precious Metals, Inc.
Dental · 111d
Cleared Dec 17, 1990
MEMORYMATE HEARING AID WITH PMC PROGRAMMER
K904020 · ESD
3M Company
Ear, Nose, Throat · 109d
Cleared Dec 17, 1990
L.P.I. LASER DELIVERY SYSTEM
K904331 · GEX
Laser Photonics, Inc.
General & Plastic Surgery · 87d
Cleared Dec 17, 1990
SI-PRO
K904389 · EYF
David F. Trungale
General & Plastic Surgery · 82d
Cleared Dec 17, 1990
ANTI-HUMAN LEU-2A (CD8) PE
K904390 · GKZ
Bd Becton Dickinson Vacutainer...
Hematology · 83d
Cleared Dec 17, 1990
HEMOCHRON(R) PROTHROMBIN TIME/MODIFICATION
K904454 · GJS
International Technidyne Corp.
Hematology · 91d
Cleared Dec 17, 1990
ADVANCE DISPOSABLE PRESSURE TRANSDUCER
K904601 · DRS
Advance Medical Designs, Inc.
Cardiovascular · 68d
Cleared Dec 17, 1990
CENTAURI YAG LASER SYST, OPHTHAMOLOGY
K904630 · GEX
Pfizer Laser Systems
General & Plastic Surgery · 69d