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
145057–145080 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 20, 1986
ACUSON L312 TRANSDUCER
K853966 · ITX
Acuson Computed Sonography
Radiology · 147d
Cleared Feb 20, 1986
GHAJAR INTRAVENTRICULAR CATHETER GUIDE
K854475 · HAW
Sparta Instrument Corp.
Neurology · 105d
Cleared Feb 20, 1986
INSERTION GAIN OPTIMIZER IGO-1000
K854535 · ETW
Madsen Electronics (Canada) , Ltd.
Ear, Nose, Throat · 99d
Cleared Feb 20, 1986
SONOLAYER S, SSH-65A
K854606 · DXK
Toshiba Medical Systems
Cardiovascular · 94d
Cleared Feb 20, 1986
PHOTIC-100 SPECTROPHOTOMETER
K854679 · JJQ
Future Impex Corp.
Chemistry · 92d
Cleared Feb 20, 1986
OTICON, CITEC CUSTOM MADE HEARING AID CANAL TYPE
K854742 · ESD
Oticon Corp.
Ear, Nose, Throat · 87d
Cleared Feb 20, 1986
OMKNEE SYSTEM, POROUS COATED
K854943
Orthomet, Inc.
Orthopedic · 72d
Cleared Feb 20, 1986
FIBER MESH
K854977 · DZE
Pulpdent Corp. of America
Dental · 70d
Cleared Feb 20, 1986
KWI (TM) G-CO/TWO
K855172 · JSK
Micro-Bio-Logics
Microbiology · 56d
Cleared Feb 20, 1986
AUSTIN ENTERIC SYSTEM
K860194 · JSE
Austin Biological Laboratories
Microbiology · 29d
Cleared Feb 20, 1986
PRECEPT TRIMETHOPRIM/SULFAMETHOXAZOLE
K860195 · JWY
Austin Biological Laboratories
Microbiology · 29d
Cleared Feb 20, 1986
PANOPTIKON
K860316 · LED
Cytocolor, Inc.
Pathology · 23d
Cleared Feb 20, 1986
NEUTROCOLOR
K860317 · LED
Cytocolor, Inc.
Pathology · 23d
Cleared Feb 20, 1986
MEGACOLOR
K860319 · LED
Cytocolor, Inc.
Pathology · 23d
Cleared Feb 20, 1986
GRANULOCOLOR
K860320 · LED
Cytocolor, Inc.
Pathology · 23d
Cleared Feb 20, 1986
LYSOCOLOR
K860321 · LED
Cytocolor, Inc.
Pathology · 23d
Cleared Feb 20, 1986
NEONATE PERCUSSOR
K860510 · BYI
Ballard Medical Products
Anesthesiology · 9d
Cleared Feb 19, 1986
ENDO-LASE CD-100 CO2 LASER FOR DERMATOLOGY
K853877 · GEX
Endo Lase, Inc.
General & Plastic Surgery · 155d
Cleared Feb 19, 1986
ENDO-LASE CD 40 FOR DERMATOLOGY
K853901 · GEX
Endo Lase, Inc.
General & Plastic Surgery · 152d
Cleared Feb 19, 1986
UVASORB-400
K854442 · HPX
Optatint, Inc.
Ophthalmic · 106d
Cleared Feb 19, 1986
INTRAOCULAR ELECTROMAGNET
K854870 · HPO
Mira, Inc.
Ophthalmic · 77d
Cleared Feb 19, 1986
ACU-SYRINGE W/WO NEEDLES
K854877 · FMF
Acuderm, Inc.
General Hospital · 75d
Cleared Feb 19, 1986
ANGIO MED DISPOSABLE PRESSURE CONNECTORS
K855078 · KGZ
Angiomed U.S., Inc.
General & Plastic Surgery · 62d
Cleared Feb 19, 1986
FRITCH OPHTHALMIC ENDOSCOPE
K855151 · GDB
Regtec
Gastroenterology & Urology · 55d