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
162553–162576 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 31, 1981
BORES* DEPTH GAUGE
K812069 · FTY
Santa Barbara Medco, Inc.
General & Plastic Surgery · 41d
Cleared Aug 31, 1981
RK IV SURGICAL BLADES
K812071 · GES
Santa Barbara Medco, Inc.
General & Plastic Surgery · 41d
Cleared Aug 31, 1981
POLAROID RADIOGRAPHIC FILM PROCESSOR
K812088 · IXW
Polaroid Corp.
Radiology · 40d
Cleared Aug 31, 1981
POLAROID RADIOGRAPHIC FILM CASSETTE
K812089
Polaroid Corp.
Radiology · 40d
Cleared Aug 31, 1981
ENXYMATIC CREATININE TEST
K812095 · JFY
Boehringer Mannheim Corp.
Chemistry · 38d
Cleared Aug 31, 1981
O.N.A.T.
K812102 · KNT
Latex Medical Devices, Inc.
Gastroenterology & Urology · 38d
Cleared Aug 31, 1981
KETAC-CHEM
K812115 · EMA
Espe-Premier Sales Co.
Dental · 35d
Cleared Aug 31, 1981
PERMAGUM
K812116 · KLE
Espe-Premier Sales Co.
Dental · 35d
Cleared Aug 31, 1981
PERMAGUM ADHESIVE
K812117 · KLE
Espe-Premier Sales Co.
Dental · 35d
Cleared Aug 31, 1981
NIMETIC POLISHING PASTE
K812118 · EJR
Espe-Premier Sales Co.
Dental · 35d
Cleared Aug 31, 1981
NIMETIC-DISPERS
K812119 · EBF
Espe-Premier Sales Co.
Dental · 35d
Cleared Aug 31, 1981
BARNES-HIND WEEKLY CLEANER
K812135 · HPX
Barnes-Hind, Inc.
Ophthalmic · 34d
Cleared Aug 31, 1981
CARDIO-DATA SYSTEM, #MARK III
K812149 · DSI
Cardio Data
Cardiovascular · 34d
Cleared Aug 31, 1981
MEDTRONIC SPECTRAX
K812153 · DXY
Medtronic Vascular
Cardiovascular · 33d
Cleared Aug 31, 1981
INTRAVASCULAR CATHETER
K812159 · FOZ
Pioneer Viggo, Inc.
General Hospital · 33d
Cleared Aug 31, 1981
MICROSURGICAL BLADE
K812160 · GES
Vxtra Corp.
General & Plastic Surgery · 33d
Cleared Aug 31, 1981
MODEL 78850 OXYGEN MONITOR
K812167 · KLK
Hewlett-Packard Co.
Anesthesiology · 32d
Cleared Aug 31, 1981
CORDIS DUCOR PERCUT. TRANS. ANGIO. CATH.
K812168 · LIT
Cordis Corp.
Cardiovascular · 32d
Cleared Aug 31, 1981
CONTACT LENS CLEANER
K812172 · HPX
Alcon Laboratories
Ophthalmic · 32d
Cleared Aug 31, 1981
SMITH'S SYSTEMIC FUNGAL MEDIUM
K812187 · JSI
American Scientific Products
Microbiology · 28d
Cleared Aug 31, 1981
CRYPTOCOCCAL ANTIGEN LATEX AGGLUTI
K812188 · GMD
American Scientific Products
Microbiology · 28d
Cleared Aug 31, 1981
COCCIDIOIDES IMMUNODIFFUSION SYSTEM
K812190 · GMI
American Scientific Products
Microbiology · 28d
Cleared Aug 31, 1981
VASPAR SEALENT
K812191 · KEO
American Scientific Products
Microbiology · 28d
Cleared Aug 31, 1981
LACTO-PHENOL ANILINE BLUE MOUNTING FLUID
K812192 · LED
American Scientific Products
Microbiology · 28d