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
127417–127440 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 26, 1990
PATIENT EXAMINATION GLOVES (LATEX)
K891662 · LYY
Darchet (Usa), Inc.
General Hospital · 312d
Cleared Jan 26, 1990
LATECHNICS LATEX EXAMINATION GLOVES
K892619 · LYY
Ssangyong Corp. (M) Sdn. Bhd.
General Hospital · 291d
Cleared Jan 26, 1990
SLEEPSCAN
K894155 · OLZ
Biologic Systems Corp.
Neurology · 226d
Cleared Jan 26, 1990
POWDER-FREE VINYL EXAMINATION GLOVES
K894686 · LYY
Dynarex Corp.
General Hospital · 185d
Cleared Jan 26, 1990
EXPANSION OF THE CORDIS PTA DILATATION CATHETER
K894899 · LIT
Cordis Corp.
Cardiovascular · 178d
Cleared Jan 26, 1990
WR3500 AND WR3600 SERIES RECORDERS
K894922 · DSF
Western Graphtec
Cardiovascular · 177d
Cleared Jan 26, 1990
TYPE 9541 RECORDER, PAPER CHART
K895111 · DSF
S & W Medico Teknik
Cardiovascular · 176d
Cleared Jan 26, 1990
AMBULATORY (HOLTER) RECORDING SYSTEM - MODIFIED
K895266 · DSI
Biosensor Corp.
Cardiovascular · 156d
Cleared Jan 26, 1990
MATRX BATTERY CHARGER/DEFIBRILLATOR TESTER
K895525 · DRL
Matrix Medica, Inc.
Cardiovascular · 136d
Cleared Jan 26, 1990
LIFE DEFENSE PLUS(TM), DEFIBRILLATOR/MONITOR/PACER
K895533 · LDD
Matrix Medica, Inc.
Cardiovascular · 135d
Cleared Jan 26, 1990
JOBST ATHROMBIC PUMP(R) SYSTEM 2000
K895732 · JOW
Jobst Institute, Inc.
Cardiovascular · 122d
Cleared Jan 26, 1990
HPD TUBING CONNECTORS
K895795 · DTL
Hpd Medical, Inc.
Cardiovascular · 121d
Cleared Jan 26, 1990
CLP ELEVATED LIPID CONTROL
K895858 · LYY
Creative Laboratory Products, Inc.
General Hospital · 115d
Cleared Jan 26, 1990
ABUSCREEN ONTRAK FOR PHENCYCLIDINE (PCP)
K895906 · LCM
Roche Diagnostic Systems, Inc.
Toxicology · 112d
Cleared Jan 26, 1990
POWDER-FREE LATEX EXAMINATION GLOVES
K895970 · LYY
Usamal Latex Products Sdn Bhd
General Hospital · 105d
Cleared Jan 26, 1990
AMBULATORY CARDIAC MONITOR
K896064 · DPS
Monitech, Inc.
Cardiovascular · 100d
Cleared Jan 26, 1990
BANDTITE GLASS IONOMER CEMENT
K896249 · EMA
American Orthodontics
Dental · 88d
Cleared Jan 26, 1990
SYSTEMA ENT CABINET
K896273 · ETF
Jedmed Instrument Co.
Ear, Nose, Throat · 88d
Cleared Jan 26, 1990
TYMPANOSCOPE
K896274 · ERA
Jedmed Instrument Co.
Ear, Nose, Throat · 88d
Cleared Jan 26, 1990
FLEXIBLE NASOPHARYNGOSCOPE
K896297 · EOB
Jedmed Instrument Co.
Ear, Nose, Throat · 88d
Cleared Jan 26, 1990
JEDMED S CHAIR
K896298 · ETF
Jedmed Instrument Co.
Ear, Nose, Throat · 88d
Cleared Jan 26, 1990
OLYMPIA FACEPLATE MODULE
K896304 · LRB
Olympia Instruments, Inc.
Ear, Nose, Throat · 88d
Cleared Jan 26, 1990
PORGES SCLEROTHERAPY NEEDLES
K896424 · FBK
Porges Corp.
Gastroenterology & Urology · 79d
Cleared Jan 26, 1990
PORGES 2-WAY BALLOON EXTRACTION CATHETER
K896504 · FGE
Porges Corp.
Gastroenterology & Urology · 72d