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
123697–123720 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 05, 1990
GASTROGRAPH
K903646 · FFT
Medics Instrument Corp.
Gastroenterology & Urology · 83d
Cleared Nov 05, 1990
MENTOR(R) DURASTAT(TM) AUTOCLAV BIPOLAR HEMOSTAT
K903878 · HQQ
Mentor O & O, Inc.
Ophthalmic · 75d
Cleared Nov 05, 1990
TITANAL,STERLING SPRING,DUAL FLEX,MEMOREX,BENDALLO
K904091 · EJF
Lancer Orthodontics, Inc.
Dental · 60d
Cleared Nov 05, 1990
CHILDRENS SUNGLASSES
K904197 · HQY
Jasco Products Co., Inc.
Ophthalmic · 54d
Cleared Nov 05, 1990
KWIKMIX
K904225 · LHI
Baxa Corp., Sub. of Cook Group, Inc.
General Hospital · 53d
Cleared Nov 05, 1990
PERCUTANEOUS INTRAVENOUS CATHETER REPAIR KIT
K904334 · LJS
Pharmacia Deltec, Inc.
General Hospital · 45d
Cleared Nov 05, 1990
CEDIA(TM) PHENOBARBITAL ASSAY
K904413 · LAF
Microgenics Corp.
Toxicology · 40d
Cleared Nov 05, 1990
ELEGANCE PROLACTIN ELISA
K904483 · CFT
Bioclone Australia Pty , Ltd.
Chemistry · 34d
Cleared Nov 05, 1990
CAP-EVAC ADAPTER
K904803 · CBN
Logan, Inc.
Anesthesiology · 12d
Cleared Nov 05, 1990
MAGNUM
K904817 · ITI
Everest & Jennings, Inc.
Physical Medicine · 12d
Cleared Nov 05, 1990
HANDI-TRACTION
K904862 · ITI
Handi-Trak, Inc.
Physical Medicine · 7d
Cleared Nov 02, 1990
FRESENIUS AS 104 CELL SEPARATOR
K895435 · LKN
Fresenius USA, Inc.
Gastroenterology & Urology · 421d
Cleared Nov 02, 1990
UNOMETER 500
K896732 · EXR
Unoplast A/S
Gastroenterology & Urology · 337d
Cleared Nov 02, 1990
MENTOR MODIFIED MALLEABLE PENILE PROSTHESES
K900371 · FAE
Mentor Corp.
Gastroenterology & Urology · 280d
Cleared Nov 02, 1990
HEVEASHIELD EXAMINATION GLOVES
K902700 · LYY
Pacificlink Export
General Hospital · 135d
Cleared Nov 02, 1990
LATEX EXAMINATION GLOVES
K902956 · LYY
Pacificlink Export Industries Private...
General Hospital · 120d
Cleared Nov 02, 1990
AFGA VIDEO IMAGER, VARIOUS MODELS
K903238 · LMC
Enhanced Imaging Technologies, Inc.
Radiology · 107d
Cleared Nov 02, 1990
ALLERGY CONTROL COVERS
K903382 · FMW
Allergy Control Products, Inc.
General Hospital · 98d
Cleared Nov 02, 1990
UNNA-SLEEVE(TM)
K903532 · LLK
Aci Medical, Inc.
General Hospital · 88d
Cleared Nov 02, 1990
BRADLEY TENACULUM HOLDER
K903649 · KDC
Marlo Surgical Technology
General & Plastic Surgery · 81d
Cleared Nov 02, 1990
COMPUTED TOMOGRAPHY X-RAY SYSTEM
K903763 · JAK
General Electric Co.
Radiology · 74d
Cleared Nov 02, 1990
PERMA MESH
K904089 · EJF
Lancer Orthodontics, Inc.
Dental · 57d
Cleared Nov 02, 1990
C.A.T.,SINTERLINE,NATURAL ARCH,MICROTWIN,BIOTORQUE
K904094 · EJF
Lancer Orthodontics, Inc.
Dental · 57d
Cleared Nov 02, 1990
CYTOSMEAR BRUSH
K904160 · HHI
Brooke Intl.
Obstetrics & Gynecology · 52d