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
128569–128592 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 24, 1989
DUMON TRACHEOBRONCHIAL STENT
K894380 · NWA
Bryan Corp.
General & Plastic Surgery · 99d
Cleared Oct 24, 1989
HEARING AID (IN-THE-EAR)
K894428 · ESD
Hearing Aid Express
Ear, Nose, Throat · 99d
Cleared Oct 24, 1989
QUANTEX ASO PLUS (LATEX,BUFFER STANDARD,CONTROL)
K894486 · GTQ
Biokit USA, Inc.
Microbiology · 98d
Cleared Oct 24, 1989
VARICELLA ZOSTER VIRUS
K894622 · GQW
Bion Ent., Ltd.
Microbiology · 96d
Cleared Oct 24, 1989
PORTABLE AIR COMPRESSOR MODEL NUMBER 8125
K894831 · BTI
Equi-Tron Mfg., Inc.
Anesthesiology · 85d
Cleared Oct 24, 1989
OS-1 OCCLUSION SYSTEM - 1
K894839 · BZC
Medical, Inc.
Anesthesiology · 85d
Cleared Oct 24, 1989
MODIFIED HEMOGLOBIN REAGENT SET
K894951 · GKK
Macomb Biotechnology, Inc.
Hematology · 96d
Cleared Oct 24, 1989
DENTIN BONDING SYSTEM
K894994 · KLE
Cosmedent, Inc.
Dental · 77d
Cleared Oct 24, 1989
3M INSTANT FIT CUSTOM EARMOLD
K895134 · ESD
3M Company
Ear, Nose, Throat · 69d
Cleared Oct 24, 1989
ASI CYSTOSCOPE SHEATH, GRASPING FORCEPS & FOR.BODY
K895182 · FAJ
Advanced Surgical Intervention, Inc.
Gastroenterology & Urology · 74d
Cleared Oct 24, 1989
FDL, INC.'S TRANSPORT SYSTEM
K895187 · JTW
Fairleigh Dickinson Laboratories, Inc.
Microbiology · 74d
Cleared Oct 24, 1989
CURAY-FORM
K895222 · EBI
Scientific Pharmaceuticals, Inc.
Dental · 69d
Cleared Oct 24, 1989
LASERMEDIC 1200 RUBY LASER SYSTEM
K895299 · GEX
Lasermetrics, Inc.
General & Plastic Surgery · 60d
Cleared Oct 24, 1989
MODEL DT-BAL, BALANCE SAVER
K895323 · KXO
Spectramed, Inc.
Obstetrics & Gynecology · 56d
Cleared Oct 24, 1989
DR. DRY
K895346 · KPN
Intellitech
Gastroenterology & Urology · 53d
Cleared Oct 24, 1989
ANTIMICROBIAL SUSCEPTIBILITY DISK
K895392 · JTN
Organon Teknika Corp.
Microbiology · 49d
Cleared Oct 24, 1989
PEMACO ECONOMY BASE PLATE WAX-MEDIUM HARD
K895565 · EGD
Pemaco, Inc.
Dental · 48d
Cleared Oct 24, 1989
L.T.C. FEEDING TUBE
K895616 · KNT
Intl. Medical Marketing, Inc.
Gastroenterology & Urology · 35d
Cleared Oct 24, 1989
CONTRAST BACKGROUND MATERIAL
K895681 · GAB
Applied Medical Technologies
General & Plastic Surgery · 33d
Cleared Oct 24, 1989
VESSEL LOOPS
K895682 · GDX
Applied Medical Technologies
General & Plastic Surgery · 33d
Cleared Oct 24, 1989
BERNARD VESSEL APPROXIMATOR
K895683 · HRQ
Applied Medical Technologies
General & Plastic Surgery · 33d
Cleared Oct 24, 1989
VESSEL OCCLUDER
K895726 · GDJ
Applied Medical Technologies
General & Plastic Surgery · 29d
Cleared Oct 24, 1989
BACKGROUND SUCTION MATT
K895727 · NAB
Applied Medical Technologies, Inc.
General & Plastic Surgery · 29d
Cleared Oct 24, 1989
THROMBELASTOGRAPH(R)
K895844 · GKP
Haemoscope Corp.
Hematology · 21d