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
143161–143184 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 15, 1986
PS2 BRAND FACIAL SYMMETRY GUIDE (LEE DESIGN)
K862576 · FTY
Professional Services For Surgeons, Ltd.
General & Plastic Surgery · 8d
Cleared Jul 14, 1986
RUBELLA ELISA TEST SYSTEM CATALOG NUMBER: 4540
K860145 · LFX
Clinical Sciences, Inc.
Microbiology · 180d
Cleared Jul 14, 1986
HEMAFLUOR REAGENT KIT
K860309 · KHO
Helena Laboratories
Chemistry · 167d
Cleared Jul 14, 1986
MICROMEDIC HTSH MONOCLONAL IRMA KIT
K860813 · JLW
Micromedic Systems
Chemistry · 132d
Cleared Jul 14, 1986
VASOVIEW DUPLEX IMAGING SYSTEM
K861237 · ITX
Sonicaid, Inc.
Radiology · 103d
Cleared Jul 14, 1986
INCUS/STAPES PROSTHESIS
K861369 · ETB
Richards Medical Co., Inc.
Ear, Nose, Throat · 94d
Cleared Jul 14, 1986
TRANSVAGINAL PROBE, MODEL ED65M-TV
K861371 · HGL
Elscint, Inc.
Obstetrics & Gynecology · 94d
Cleared Jul 14, 1986
WHITESIDE CONDYLAR II TOTAL KNEE PROSTHESIS
K861715 · HSX
Dow Corning Wright
Orthopedic · 70d
Cleared Jul 14, 1986
CUSHION-FLEX TM NASAL CPAP MASK FOR SLEEP APNEA
K861758 · BYE
Life Design Systems, Inc.
Anesthesiology · 69d
Cleared Jul 14, 1986
MEDTRON TYPE P-300 ULTRASONIC THERAPY UNIT
K861864 · IMJ
I-Rep, Inc.
Physical Medicine · 60d
Cleared Jul 14, 1986
HAWKINS MINI-E.B.A.
K862031 · IPF
Pb Sales C/O Geller & Bozeman
Physical Medicine · 47d
Cleared Jul 14, 1986
SALTZMAN EAR(TM) ENDOTRACHEAL ASCULTATION RECEPTOR
K862131 · BZT
K & S Medicorp
Anesthesiology · 40d
Cleared Jul 14, 1986
MODIFIED WHITESIDE POSTERIOR STABILIZED TOTAL KNEE
K862136 · HSX
Dow Corning Wright
Orthopedic · 40d
Cleared Jul 14, 1986
MP-500 ELECTRONIC NEBULIZER
K862171 · KFZ
The Timeter Group
Anesthesiology · 35d
Cleared Jul 14, 1986
ISOPURE LC SYSTEM
K862178 · LDM
The Perkin-Elmer Corp.
Chemistry · 35d
Cleared Jul 14, 1986
MICROTEK INTRANASAL SPLINT
K862496 · EPP
Microtek Medical, Inc.
Ear, Nose, Throat · 13d
Cleared Jul 14, 1986
MICROTEK SEPTAL BUTTON
K862497 · LFB
Microtek Medical, Inc.
Ear, Nose, Throat · 13d
Cleared Jul 14, 1986
UNIVERSAL STAND FOR FILM CHANGER
K862575 · KPX
Canon USA, Inc.
Radiology · 7d
Cleared Jul 11, 1986
CANDI-KIT TM
K854672 · JSI
Culture Kits, Inc.
Microbiology · 232d
Cleared Jul 11, 1986
MICROTEK STAINLESS STEEL PISTON
K860460 · ETB
Microtek Medical, Inc.
Ear, Nose, Throat · 155d
Cleared Jul 11, 1986
SOLID PHASE BOIL DUALCOUNT (DUALCOUNT SPB)
K860815 · CDD
Diagnostic Products Corp.
Chemistry · 129d
Cleared Jul 11, 1986
TORAY SUPERSELECTIVE GUIDEWIRE,SUPERSELEC Y-K TYPE
K861115 · DQX
Toray Industries (America), Inc.
Cardiovascular · 108d
Cleared Jul 11, 1986
DELFIA DIGOXIN
K861195 · KXT
Lkb Instruments, Inc.
Toxicology · 102d
Cleared Jul 11, 1986
SERIES TEN THOUSAND MASTER
K861380 · HQE
CooperVision, Inc.
Ophthalmic · 88d