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
164881–164904 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 19, 1980
BUCKBERG-SHILEY BLOOD CARDIOPLEGIC SPL.
K802879 · DTR
Shiley, Inc.
Cardiovascular · 32d
Cleared Dec 19, 1980
ABSELE* ABSORBABLE BONE SEALANT
K802881
Ethicon, Inc.
Ophthalmic · 32d
Cleared Dec 19, 1980
T3-SQUIBB RIA KIT
K802883 · CDP
E. R. Squibb & Sons, Inc.
Chemistry · 32d
Cleared Dec 19, 1980
ARGYLE DOUBLE SEAL CHEST DRAINAGE UNIT
K802891 · CCJ
Sherwood Medical Co.
Anesthesiology · 32d
Cleared Dec 19, 1980
CERAMIBOND
K802899 · DYW
Zulauf, Inc.
Dental · 32d
Cleared Dec 19, 1980
CYBREX CARBAMAZEPINE
K802902 · KLT
Abbott Laboratories
Immunology · 32d
Cleared Dec 19, 1980
6-435 FILTER PAD, 5/PKG.
K802914 · CAH
Lifecare Services, Inc.
General Hospital · 31d
Cleared Dec 19, 1980
MONTG. TRACHEAL TREPHINE FENE STRATOR
K802915 · KBF
Boston Medical Products, Inc.
Ear, Nose, Throat · 30d
Cleared Dec 19, 1980
MONTG. TRACHEAL CANNULA
K802916 · BTO
Boston Medical Products, Inc.
Anesthesiology · 30d
Cleared Dec 19, 1980
BECKMAN ASTRA SYSTEMS CALCIUM CHEMISTRY
K802923 · CIC
Beckman Instruments, Inc.
Chemistry · 31d
Cleared Dec 19, 1980
6-415 FILTER, ELEMENT, 170-C
K802925 · DSK
Lifecare Services, Inc.
Cardiovascular · 30d
Cleared Dec 19, 1980
SCI-PHARM UNIVERSAL CAVITY VARNISH
K802926 · LBH
Scientific Pharmaceuticals, Inc.
Dental · 30d
Cleared Dec 19, 1980
PRESSURE MONITORING SET
K802945 · DQO
Norton Performance Plastics Corp.
Cardiovascular · 30d
Cleared Dec 19, 1980
MONITOR, AIRWAY PRESSURE
K802955 · CAP
Novametrix Medical Systems, Inc.
Anesthesiology · 29d
Cleared Dec 19, 1980
NIKON URINE REFRACTOMER SG-1
K802959 · JRE
Nippon Kogaku, Inc.
Chemistry · 29d
Cleared Dec 19, 1980
101, 151, 161 PORTABLE AUDIOMETERS
K802963 · EWO
Amplaid USA, Inc.
Ear, Nose, Throat · 28d
Cleared Dec 19, 1980
ISPVAC TM
K802973 · GCY
Innovative Surgical Products, Inc.
General & Plastic Surgery · 31d
Cleared Dec 19, 1980
RAPI-DOT
K802974 · JHJ
Organon, Inc.
Chemistry · 28d
Cleared Dec 19, 1980
CARBONACRYL
K802976
Ipos Luneburg
Physical Medicine · 28d
Cleared Dec 19, 1980
IPOCARBON STRETCH STOCKINETTE
K802977
Ipos Luneburg
Physical Medicine · 28d
Cleared Dec 19, 1980
DISPOSABLE STERILE LAP SPONGE
K802980 · KKX
Anago, Inc.
General Hospital · 25d
Cleared Dec 19, 1980
GAUZE, ABSORBABLE X-RAY DETECT. LAP SPG.
K802982 · GDY
Stanford Laboratories
General & Plastic Surgery · 25d
Cleared Dec 18, 1980
SILASTIC II MAMMARY IMPLANT
K801175
Dow Corning Corp. Healthcare...
General & Plastic Surgery · 216d
Cleared Dec 18, 1980
THE BRAVO NEW PARALLEL FLOW DIALYZER
K801633 · FJG
Bellco Artifidial Organ Spec., Inc.
Gastroenterology & Urology · 156d