FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
92281–92304 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 06, 1997
ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM
K973367 · CHL
Radiometer America, Inc.
Chemistry · 28d
Cleared Oct 06, 1997
CEFPODOXIME ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K973487 · JTN
Oxoid , Ltd.
Microbiology · 21d
Cleared Oct 03, 1997
GE LOGIQ 700 DIAGNOSTIC ULTRASOUND SYSTEM
K964617 · IYO
GE Medical Systems
Radiology · 340d
Cleared Oct 03, 1997
EXPERT-XL TOTAL BODY ACQUISITION AND ANALYSIS SOFTWARE
K965226 · KPS
Lunar Corp.
Radiology · 277d
Cleared Oct 03, 1997
HEWLETT APCKARD SERIES 50 OB TRACEVUE OBSTETRICAL SURVEILLANCE AND ARCHIVING...
K970456 · HGM
Hewlett-Packard GmbH
Obstetrics & Gynecology · 239d
Cleared Oct 03, 1997
NIVP3 (WINDOWS VERSION OF NIVP
K970570 · DQK
D. E. Hokanson, Inc.
Cardiovascular · 231d
Cleared Oct 03, 1997
MAGELLAN MAGNETIC DISTAL TARGETING SYSTEM(PROPOSED NAME), PRODUCT LINE EXTENSION
K971056 · HSB
Wrightmedicaltechnologyinc
Orthopedic · 193d
Cleared Oct 03, 1997
FUKUDA DENSHI MODEL DS-5100E PORTABLE PATIENT MONITOR
K971131 · DSI
Fukuda Denshi USA, Inc.
Cardiovascular · 190d
Cleared Oct 03, 1997
BABYTHERM 8004 BABYTHERM 8010
K971198 · FMT
Drager, Inc.
General Hospital · 186d
Cleared Oct 03, 1997
VTU-1 VACUUM ERECTION SYSTEM
K971257 · LKY
Mckenna & Cuneo
Gastroenterology & Urology · 182d
Cleared Oct 03, 1997
INNOSAN TRAVELAIR S PLUS PORTABLE OXYGEN CONCENTRATOR, CODE NO. M407001853...
K971947 · CAW
Sim Italia S.R.L.
Anesthesiology · 128d
Cleared Oct 03, 1997
MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE
K972169 · LZA
Pwa Industries Sdn. Bhd.
General Hospital · 116d
Cleared Oct 03, 1997
LASEREX LP1532 PHOTOCOAGULATOR
K972514 · HQF
Ellex Medical Pty, Ltd.
Ophthalmic · 88d
Cleared Oct 03, 1997
EYE SPHERE, CONFORMERS
K972661 · HPZ
Gulden Ophthalmics
Ophthalmic · 79d
Cleared Oct 03, 1997
AIA-PACK IGE II ASSAY
K972697 · DGC
Tosoh Medics, Inc.
Immunology · 77d
Cleared Oct 03, 1997
TEMP BOND CLEAR
K972844 · EMA
Kerr Dental Materials Center
Dental · 63d
Cleared Oct 03, 1997
VIDAS ROTAVIRUS (RTV) ASSAY
K972895 · LIQ
Biomerieux Vitek, Inc.
Microbiology · 59d
Cleared Oct 03, 1997
PLS-96P
K973088 · EJJ
Southern Dental Industries, Inc.
Dental · 46d
Cleared Oct 03, 1997
INNOVATOME MICROKERATOME
K973294 · HNO
Innovative Optics, Inc.
Ophthalmic · 31d
Cleared Oct 03, 1997
CHEMMATE UCHL1 (CD45RO) PREDILUTED ANTIBODY FOR IMMUNOHISTOCHEMICAL STAINING
K973389 · DEM
Ventana Medical Systems, Inc.
Immunology · 85d
Cleared Oct 03, 1997
CHEMMATE L26 (CD20)
K973390 · DEM
Ventana Medical Systems, Inc.
Immunology · 85d
Cleared Oct 03, 1997
CHEMMATE KAPPA
K973391 · DEM
Ventana Medical Systems, Inc.
Immunology · 85d
Cleared Oct 03, 1997
CHEMMATE LAMBDA
K973392 · DEM
Ventana Medical Systems, Inc.
Immunology · 86d
Cleared Oct 02, 1997
MEDCORP FLOW I.V. REGULATOR EXTENSION SET
K971004 · FPA
Medcorp Intl.
General Hospital · 197d