Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
158953–158976 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 30, 1982
HOLDER FOR MOUTH STICK
K823624 · ILP
Fred Sammons, Inc.
Physical Medicine · 24d
Cleared Dec 30, 1982
MOUTH STICK KIT
K823625 · ILP
Fred Sammons, Inc.
Physical Medicine · 24d
Cleared Dec 30, 1982
DISPOSABLE TOOTH BRUSH
K823626 · ILS
Fred Sammons, Inc.
Physical Medicine · 24d
Cleared Dec 30, 1982
FORMED STEEL DEVICE KEEP LEGS SEPARATED
K823629
Fred Sammons, Inc.
Physical Medicine · 24d
Cleared Dec 30, 1982
DELUXE KNEE IMMOBILIZER(UNIVERSAL)
K823658 · ITQ
Warm & Form, Orthopedic Materials
Physical Medicine · 24d
Cleared Dec 30, 1982
PELVIC TRACTION BELT
K823659 · ILZ
Warm & Form, Orthopedic Materials
Physical Medicine · 24d
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