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
166537–166560 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 16, 1980
NOVA 4 SODIUM/POTASSIUM/CHLORIDE/CARBON
K801882 · JGS
Nova Biomedical Corp.
Chemistry · 40d
Cleared Sep 16, 1980
WAKO TRIGLYCERIDE-G TEST
K801891 · CDT
Wako Pure Chemical Industries, Ltd.
Chemistry · 39d
Cleared Sep 16, 1980
CORNING 60 VOLT POWER SUPPLY
K801893 · JJN
Corning Medical & Scientific
Chemistry · 39d
Cleared Sep 16, 1980
BECKMAN ELECTROLYTE-2 SODIUM/POTASSIUM
K801896 · JGS
Beckman Instruments, Inc.
Chemistry · 39d
Cleared Sep 16, 1980
ALGESIOMETER
K801907 · GXB
Rowan Products, Inc.
Neurology · 36d
Cleared Sep 16, 1980
ARROW POSITIVE PLACEMENT CON/EPIDURAL AN
K801912 · CAZ
Arrow Intl., Inc.
Anesthesiology · 36d
Cleared Sep 16, 1980
STAR
K801917 · JWM
General Electric Co.
Radiology · 36d
Cleared Sep 16, 1980
BLEPHAROMETER
K801937 · HOE
Aztec Medical Products, Inc.
Ophthalmic · 35d
Cleared Sep 16, 1980
OHIO THORACIC COLLECTION UNIT
K801942 · GCX
Ohio Medical Products
General Hospital · 34d
Cleared Sep 16, 1980
SPINE ALIGN
K801952 · KYI
B.H. Richardson, D.C.
Orthopedic · 29d
Cleared Sep 16, 1980
TISSUE-TEK III TISSUE EMBEDDING CENTER
K801956
Miles Laboratories, Inc.
Pathology · 29d
Cleared Sep 16, 1980
ARGYLE COMPACT CHEST DRAINAGE SYSTEM
K801979 · GCX
Sherwood Medical Co.
General Hospital · 28d
Cleared Sep 16, 1980
THE MCSHIRLEY PERCUSSOR
K801982 · BYI
Mcshirley Products, Inc.
Anesthesiology · 28d
Cleared Sep 16, 1980
NORDICLAB FERRITIN IRMA TEST
K801989 · DBF
Nordiclab Intl.
Immunology · 28d
Cleared Sep 16, 1980
PLASTIC FORCEPS CAT.#1001-1010
K801991 · GEN
Pollak (Intl.), Ltd.
General & Plastic Surgery · 27d
Cleared Sep 16, 1980
GUAZE BANDAGES CAT.#101-169
K801996 · NAB
Pollak (Intl.), Ltd.
General & Plastic Surgery · 27d
Cleared Sep 16, 1980
GUAZE BALLS CAT.#601-720
K801999 · EFQ
Pollak (Intl.), Ltd.
General & Plastic Surgery · 27d
Cleared Sep 16, 1980
LAP SPONGES CAT.#801-850
K802001 · KKX
Pollak (Intl.), Ltd.
General Hospital · 27d
Cleared Sep 16, 1980
PROFILE SWAB CAT.#5273 & 5274
K802004 · KXG
Pollak (Intl.), Ltd.
General & Plastic Surgery · 27d
Cleared Sep 16, 1980
ABSORBENT PAD CAT.#729, 732, 730, 731
K802005 · EFQ
Pollak (Intl.), Ltd.
General & Plastic Surgery · 27d
Cleared Sep 16, 1980
TRIANGULAR BANDAGE CAT.#191
K802006 · ILI
Pollak (Intl.), Ltd.
General & Plastic Surgery · 27d
Cleared Sep 16, 1980
GUAZE SWABS CAT.#251-300 (SIZE & PLY)
K802010 · EFQ
Pollak (Intl.), Ltd.
General & Plastic Surgery · 27d
Cleared Sep 16, 1980
FIRST AID BANDAGE CAT.#198 OR 199
K802013 · KGX
Pollak (Intl.), Ltd.
General & Plastic Surgery · 27d
Cleared Sep 16, 1980
EYE APPLICATORS CAT.#980-983
K802016 · KXF
Pollak (Intl.), Ltd.
General Hospital · 27d