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
128017–128040 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jan 26, 1990
PORGES ENDOSCOPIC DORMIA EXTRACTORS, DORMIATRIPTOR
K896506 · FGE
Porges Corp.
Gastroenterology & Urology · 72d
Cleared Jan 26, 1990
SFA MODULE
K896528 · DXG
Life Sciences Manufacturing, Inc.
Cardiovascular · 71d
Cleared Jan 26, 1990
MEDTRONIC SPECTRAX SXT MODEL 8423M PULSE GENERATOR
K896809 · DXY
Medtronic Vascular
Cardiovascular · 53d
Cleared Jan 26, 1990
VENTLAB ANESTHESIA CIRCUIT AC 6000
K896897 · CAI
Ventlab Corp.
Anesthesiology · 49d
Cleared Jan 26, 1990
DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOSIS CONTROLS
K896926 · KTN
Quidel Corp.
Immunology · 46d
Cleared Jan 26, 1990
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K896957 · LYY
Honyee Enterprise Co.
General Hospital · 43d
Cleared Jan 26, 1990
AIRWAY DELIVERY & MANAGEMENT (ADAM) NASAL VENTILA.
K900164 · BYE
Puritan Bennett Corp.
Anesthesiology · 14d
Cleared Jan 26, 1990
MODIFIED HEARTSTART 2000 DEFIBRILLATION ELECTRODE
K900169 · LDD
Laerdal Mfg. Corp.
Cardiovascular · 14d
Cleared Jan 25, 1990
RESUBMITTED FECATWIN SENSITIVE - FECA-EIA
K896474 · KHE
Labsystems, Inc.
Hematology · 73d
Cleared Jan 25, 1990
LATEX NON-POWDERED EXAMINATION GLOVES
K896872 · LYY
Thaisan Industries Co., Ltd.
General Hospital · 48d