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
127033–127056 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 10, 1990
VISUWELL(R) REAGIN TEST (MODIFICATION)
K900338 · GMQ
Adi Diagnostics, Inc.
Microbiology · 77d
Cleared Apr 10, 1990
SHARPLAN ND:YAG LASERS FOR ENT AND NECK SURGERY
K900345 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 77d
Cleared Apr 10, 1990
BIRTCHER FOOTCONTROLLED SUCTION COAGULATOR
K900347 · GEI
Birtcher Electro Medical Systems
General & Plastic Surgery · 77d
Cleared Apr 10, 1990
HAND SURGERY AND IRRIGATION TRAY (MODEL 3625)
K900376 · FSM
Pmt Corp.
General & Plastic Surgery · 74d
Cleared Apr 10, 1990
EMG OPTION FOR MICROSHEV 4000
K900378 · JXE
Micro-Shev , Ltd.
Neurology · 74d
Cleared Apr 10, 1990
FUKUDA DENSHI MODEL SPIROSIFT 3000
K900391 · BZG
Fukuda Denshi USA, Inc.
Anesthesiology · 74d
Cleared Apr 10, 1990
DISPOSABLE SCREW TYPE PROPHY BRUSH
K900507 · EHK
Dentsply Intl.
Dental · 67d
Cleared Apr 10, 1990
PERTAC BOND
K900558 · KLE
Espe GmbH (Us)
Dental · 62d
Cleared Apr 10, 1990
TRANS X 100 CHEST FILM CHANGER
K900562 · KPR
Acoma Medical Imaging, Inc.
Radiology · 62d
Cleared Apr 10, 1990
THERMOPROBE 210
K900569 · BTT
Merced Medical, Inc.
Anesthesiology · 62d
Cleared Apr 10, 1990
SPORTS PACK ELASTICS
K900578 · EJF
Lancer Orthodontics, Inc.
Dental · 62d
Cleared Apr 10, 1990
FLO-GARD 6300 BLOOD PUMPING INDICATION
K900699 · FRN
Baxter Healthcare Corp
General Hospital · 56d
Cleared Apr 10, 1990
SHILEY VEIN IRRIGATION CANNULA (BEVELED & BLUNT)
K900753 · DWF
Shiley, Inc.
Cardiovascular · 53d
Cleared Apr 10, 1990
'POLYSTIM'
K900825 · GXY
Medical Science Products, Inc.
Neurology · 48d
Cleared Apr 10, 1990
HEARING AID (ALL-IN-THE-EAR)
K900968 · ESD
Audiology of Tulsa, Inc.
Ear, Nose, Throat · 39d
Cleared Apr 10, 1990
VECTRA(TM)
K901100 · HQY
Optical Coating Laboratory, Inc.
Ophthalmic · 34d
Cleared Apr 10, 1990
OMNIVIEW DIGITAL RADIOLOGY IMAGING SYSTEM
K901118 · LMB
Adac Laboratories
Radiology · 29d
Cleared Apr 10, 1990
OTICON BTE HEARING AID (BEHIND-THE-EAR), MODEL E44
K901292 · ESD
Oticon Corp.
Ear, Nose, Throat · 21d
Cleared Apr 10, 1990
WIDEX MODEL Q9, BTE W/QUATRO REMOTE CONTROL
K901316 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 20d
Cleared Apr 10, 1990
WIDEX MODEL Q12 BTE WITH QUATRO REMOTE CONTROL
K901317 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 20d
Cleared Apr 10, 1990
ANESTHESIA WORKSTATION
K901474 · BRY
Siemens Life Support Systems
Anesthesiology · 14d
Cleared Apr 10, 1990
MACINTOSH LARYNGOSCOPE BLADES (AMERICAN PROFILE)
K901489 · CCW
Eastmed Enterprises, Inc.
Anesthesiology · 12d
Cleared Apr 09, 1990
GUARDIAN FORCEP
K893636 · FCL
Endo-Scientific, Inc.
Gastroenterology & Urology · 332d
Cleared Apr 09, 1990
DESERET INTRAVASCULAR CATHETER
K895734 · FOZ
Deseret Medical, Inc.
General Hospital · 195d