FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
128209–128232 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 16, 1990
MODEL 340 PROBE MIC SYSTEM
K896301 · ETW
Virtual Corp.
Ear, Nose, Throat · 78d
Cleared Jan 16, 1990
BASIC CALCIUM HYDROXIDE LINER
K896529 · EJK
Ivoclar North America, Inc.
Dental · 63d
Cleared Jan 16, 1990
EBV VCA ANTIBODY (IGM)
K896594 · LJN
Hillcrest Biologicals
Microbiology · 56d
Cleared Jan 12, 1990
OPTISOL
K894162 · LYX
Chiron Ophthalmics
Ophthalmic · 212d
Cleared Jan 12, 1990
ASTRA DISPOSABLE SPRAY CANNULA
K894755 · CCT
Astra Pharmaceutical Products, Inc.
Anesthesiology · 169d
Cleared Jan 12, 1990
LIFECARE NASAL MASK KIT CAT. NO. 06-800
K894779 · BYE
Lifecare Services, Inc.
Anesthesiology · 169d
Cleared Jan 12, 1990
VAC FIX(R) SYSTEM
K895697 · IYE
S&S Par Scientific
Radiology · 113d
Cleared Jan 12, 1990
DIGITAL ULTRASOUND IMAGING SYSTEM DUB 20
K896029 · IYO
G.W.B. Intl., Ltd.
Radiology · 87d
Cleared Jan 12, 1990
AMNIOTIC FLUID SAMPLER (AMNIOCENTESIS TRAY)
K896031 · HIO
Concord/Portex
Obstetrics & Gynecology · 88d
Cleared Jan 12, 1990
MAGNAVIEW M.R.I. VERSIONS 110FH & 110FM W/CARDIAC
K896309 · LNH
Instrumentarium Imaging, Inc.
Radiology · 72d
Cleared Jan 12, 1990
SEMPERMED LATEX EXAMINATION GLOVES
K896428 · LYY
Semperit Industrial Products
General Hospital · 65d
Cleared Jan 12, 1990
VISTA MR 2055 HP SYSTEM
K896508 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 58d
Cleared Jan 12, 1990
LIBERTY SPECIAL AND LIBERTY STAIRLIFTS
K896628 · ILK
The Cheney Co.
Physical Medicine · 52d
Cleared Jan 12, 1990
DISPOSABLE FACE MASK
K896773 · BYG
Cadema Medical Products, Inc.
Anesthesiology · 42d
Cleared Jan 12, 1990
HANDI PORCH ELEVATOR
K897019 · ING
The Cheney Co.
Physical Medicine · 24d
Cleared Jan 12, 1990
LINCOLN MILLS FOOT AND LEG HOLDER
K897028 · FWZ
Lincoln Mills, Inc.
General & Plastic Surgery · 24d
Cleared Jan 12, 1990
MODIFIED SPIROSCAN 1000
K897094 · BZG
Fukuda Denshi USA, Inc.
Anesthesiology · 23d
Cleared Jan 12, 1990
FORTRESS 755FS PEDIATRIC WHEELCHAIR
K900037 · ITI
Fortress Scientific , Ltd.
Physical Medicine · 10d
Cleared Jan 12, 1990
FORTRESS 760FS POWER WHEELCHAIR
K900038 · ITI
Fortress Scientific , Ltd.
Physical Medicine · 10d
Cleared Jan 12, 1990
FORTRESS VICTORY POWER WHEELCHAIR
K900039 · ITI
Fortress Scientific , Ltd.
Physical Medicine · 10d
Cleared Jan 12, 1990
FORTRESS SPIRIT POWER WHEELCHAIR
K900040 · ITI
Fortress Scientific , Ltd.
Physical Medicine · 10d
Cleared Jan 12, 1990
FORTRESS LIBERATOR RWD SCOOTER
K900041 · INI
Fortress Scientific , Ltd.
Physical Medicine · 10d
Cleared Jan 12, 1990
FORTRESS BUDDY FRONT WHEEL DRIVE SCOOTER
K900042 · INI
Fortress Scientific , Ltd.
Physical Medicine · 10d
Cleared Jan 11, 1990
PATIENT EXAMINATION GLOVES (LATEX)
K891277 · LYY
Grace River Ent., Inc.
General Hospital · 302d