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
158113–158136 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 30, 1982
UNIVERSAL BUCKS TRACTION
K823660 · KQZ
Warm & Form, Orthopedic Materials
Orthopedic · 24d
Cleared Dec 30, 1982
CLAVICLE SUPPORT
K823661 · IQJ
Warm & Form, Orthopedic Materials
Physical Medicine · 24d
Cleared Dec 30, 1982
RIB BELT (UNIVERSAL)
K823662 · IPX
Warm & Form, Orthopedic Materials
Physical Medicine · 24d
Cleared Dec 30, 1982
ABDOMINAL BINDER
K823663 · KTD
Warm & Form, Orthopedic Materials
Physical Medicine · 24d
Cleared Dec 30, 1982
UNIVERSAL SLING, SLING & SWATHE
K823664 · ILI
Warm & Form, Orthopedic Materials
Physical Medicine · 24d
Cleared Dec 30, 1982
ROTATION BOOT
K823665 · KNP
Warm & Form, Orthopedic Materials
Physical Medicine · 24d
Cleared Dec 30, 1982
UNIVERSAL WRIST SPLINT & FOREARM SPLINT
K823666 · ILH
Warm & Form, Orthopedic Materials
Physical Medicine · 24d
Cleared Dec 30, 1982
CERVICAL COLLAR
K823667 · IQK
Warm & Form, Orthopedic Materials
Physical Medicine · 24d
Cleared Dec 30, 1982
ANTI SERA TO HUMAN OROSCOMUCOID
K823765 · DEX
Kent Laboratories, Inc.
Immunology · 16d
Cleared Dec 29, 1982
FEP-RINGED GORE-TEX@ VASCULAR GRAFT
K821826 · DYF
W.L. Gore & Associates, Inc.
Cardiovascular · 190d
Cleared Dec 28, 1982
HUMAN PLASMA CONTROL FOR CEA-ROCHE
K822219 · JJX
Hoffmann-La Roche, Inc.
Immunology · 155d
Cleared Dec 28, 1982
OPERATING ROOM PROCEDURAL PACK
K822804
Adicon
General & Plastic Surgery · 102d
Cleared Dec 28, 1982
MOXALACTAM
K822866 · JTT
Lilly Research Laboratories
Microbiology · 92d
Cleared Dec 28, 1982
MINI-VAC DRAIN SYSTEM
K822902 · GCY
Angus Medical Co.
General & Plastic Surgery · 90d
Cleared Dec 28, 1982
5031 BRIGHT FLASH STIMULATOR
K822915 · HLX
Life-Tech Intl., Inc.
Ophthalmic · 88d
Cleared Dec 28, 1982
5010 VISUSTIM
K822919 · HLX
Life-Tech Intl., Inc.
Ophthalmic · 88d
Cleared Dec 28, 1982
5011 GANZFELD STIMULATOR
K822922 · HLX
Life-Tech Intl., Inc.
Ophthalmic · 88d
Cleared Dec 28, 1982
5012 PARABOLIC STIMULATOR
K822923 · HLX
Life-Tech Intl., Inc.
Ophthalmic · 88d
Cleared Dec 28, 1982
CANDIDA DETECTION SYSTEM
K823016 · LHK
Ramco Laboratories, Inc.
Microbiology · 77d
Cleared Dec 28, 1982
CORDIA CMV
K823123 · LFZ
Cordis Corp.
Chemistry · 67d
Cleared Dec 28, 1982
INTRAOCULAR LENS GUIDE
K823222 · KYB
American Medical Optics
Ophthalmic · 60d
Cleared Dec 28, 1982
NEW FREEDOM THIN UNSCENTED MAXI PADS
K823241 · HHD
Kimberly-Clark Corp.
Obstetrics & Gynecology · 57d
Cleared Dec 28, 1982
FACTOR VIII RELATED ANTIGEN ROCKET EID
K823267 · GGP
Helena Laboratories
Hematology · 56d
Cleared Dec 28, 1982
IMMOPHASE TM HPL RADIOIMMUNOASSAY
K823292 · JMF
Corning Medical & Scientific
Chemistry · 53d