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
165697–165720 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Sep 16, 1980
SUTURE REMOVAL SET CAT.#906
K802019 · KDD
Pollak (Intl.), Ltd.
General & Plastic Surgery · 27d
Cleared Sep 16, 1980
PEDIBAND CAT.#195-197
K802021 · NAD
Pollak (Intl.), Ltd.
General & Plastic Surgery · 27d
Cleared Sep 16, 1980
STERILE GUAZE SWABS CAT.#301-420
K802022 · EFQ
Pollak (Intl.), Ltd.
General & Plastic Surgery · 27d
Cleared Sep 16, 1980
3390A REPORTING INTEGRATOR
K802031 · LDM
Hewlett-Packard Co.
Toxicology · 26d
Cleared Sep 16, 1980
AMPCO SKIN SCRUB TRAYS, CAT.#SS824
K802042 · LDQ
Associated Medical Products Co.
General & Plastic Surgery · 28d
Cleared Sep 16, 1980
AMPCO SKIN SCRUB TRAYS, CAT.#SS843
K802043 · LDQ
Associated Medical Products Co.
General & Plastic Surgery · 28d