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
165073–165096 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 02, 1980
GENERATOR, HIGH VOLT, X-RAY, MPX 125
K802550 · IZO
General Electric Co.
Radiology · 48d
Cleared Dec 02, 1980
GENERATOR, HIGH VOLT, X-RAY, MPX100/125
K802551 · IZO
General Electric Co.
Radiology · 48d
Cleared Dec 02, 1980
PHADEBAS RAST TEST
K802556 · DHB
Pharmacia, Inc.
Immunology · 47d
Cleared Dec 01, 1980
INTERMEDICS' LIFELINE TLE ENDOCARDIAL
K801172 · DTB
Intermedics, Inc.
Cardiovascular · 199d
Cleared Dec 01, 1980
LOW PROFILE LEAD CONNECTOR MODIFICATION (4002)
K801284 · DTB
Medtronic Vascular
Cardiovascular · 186d
Cleared Dec 01, 1980
SIEMENS-ELEMA PULSE GENERATOR 668
K801324 · DXY
Siemens Elema AB
Cardiovascular · 181d
Cleared Dec 01, 1980
TRAVENOL ULTRASONIC NEBULIZER CUPS
K802054 · CAP
Travenol Laboratories, S.A.
Anesthesiology · 98d
Cleared Dec 01, 1980
GRISTINA GLENOID PROSTHESIS
K802124 · KWT
Howmedica Corp.
Orthopedic · 88d
Cleared Dec 01, 1980
SOLAR TONE
K802304 · LEJ
Bloomex International, Inc.
Radiology · 69d
Cleared Dec 01, 1980
T/K (ATA/AMA) UNIVERSAL BIOPAK
K802308 · DBM
Bioware Products
Immunology · 69d
Cleared Dec 01, 1980
MS-2 IDENTIFICATION SYSTEM
K802309 · JXB
Abbott Laboratories
Microbiology · 69d
Cleared Dec 01, 1980
VON WILLEBRAND FACTOR ASSAY
K802356 · GGP
Bio/Data Corp.
Hematology · 66d
Cleared Dec 01, 1980
GLYCO-TROL HUMAN GLYCOSYLATED HOM. CONT.
K802432 · LCP
Clin Tech Diagnostics Corp.
Hematology · 56d
Cleared Dec 01, 1980
SINVISION 2001 ULTRASOUND SCANNER
K802484
National Ultrasound Corp.
Obstetrics & Gynecology · 46d
Cleared Dec 01, 1980
TENSMATE EMPIMODEL 9980
K802507 · GZJ
Empi
Neurology · 47d
Cleared Nov 28, 1980
AUXILIARY TRAY
K802088 · FSM
American Pharmaseal Div. Ahsc
General & Plastic Surgery · 87d
Cleared Nov 26, 1980
GENERAL ULTRASOUND EXAM. TABLE
K802254 · IYN
Engineering Dynamics Corp.
Radiology · 71d
Cleared Nov 26, 1980
PERICARDIOCENTESIS KIT
K802289 · DOR
Stanco Medical, Inc.
Toxicology · 68d
Cleared Nov 26, 1980
PDS THERMAL DILUTION CARDIAC MODULE(OUT)
K802316 · DXG
General Electric Co.
Cardiovascular · 64d
Cleared Nov 26, 1980
SPECIAL PROCEDURE AQAROSE FILM
K802395 · JJN
Electrophoresis Corp.
Chemistry · 55d
Cleared Nov 26, 1980
GENERAL PROCEDURE AGAROSE FILM
K802396 · JJN
Electrophoresis Corp. of America
Chemistry · 55d
Cleared Nov 26, 1980
BIOMETRIC ERG SYSTEM
K802472 · DSI
Biometric Analysis Group, Inc.
Cardiovascular · 48d
Cleared Nov 26, 1980
A2 IMAGE PROCESSING SYSTEM
K802475 · IYX
Medtronic Vascular
Radiology · 48d
Cleared Nov 26, 1980
CHEMISTRY ANALYZER IMPACT 400
K802609 · JJE
Gilford Instrument Laboratories, Inc.
Chemistry · 36d