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
126433–126456 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 10, 1990
MOTIONSPECT
K895881 · LXW
Baltimore Therapeutic Equipment Co.
Gastroenterology & Urology · 187d
Cleared Apr 10, 1990
SILHOUETTE PORCELAIN
K895888 · EIH
Leach and Dillon Co., Inc.
Dental · 187d
Cleared Apr 10, 1990
SOLOSTICK (AMPLATZ DILATOR NEEDLE)
K896096 · DRE
Microvena Corp.
Cardiovascular · 172d
Cleared Apr 10, 1990
LISS BODY STIMULATOR MODEL SBL501-M
K896226 · GZJ
Medical Consultants Intl. , Ltd.
Neurology · 161d
Cleared Apr 10, 1990
UPSIZING LEAD ADAPTERS 5.0MM PEEL-AWAY ADAPTER
K896438 · DTD
Telectronics Pacing Systems, Inc.
Cardiovascular · 152d
Cleared Apr 10, 1990
PTI INTRA-ART(TM) ANSARI SAPHENOUS VEIN HOLDER
K897075 · DXC
Pioneering Technologies, Inc.
Cardiovascular · 111d
Cleared Apr 10, 1990
MODEL M1175A/M1176A WITH ST SEGMENT MONITORING
K900032 · DRT
Hewlett-Packard Co.
Cardiovascular · 98d
Cleared Apr 10, 1990
ENT-2 FLEXIBLE NASOPHARYGNO-LARYNGOSCOPES
K900176 · EOB
Machida, Inc.
Ear, Nose, Throat · 88d
Cleared Apr 10, 1990
BONCHEK-SHILEY CARDIAC JACKET W/RECIRCULATION SET
K900186 · DWJ
Shiley, Inc.
Cardiovascular · 84d
Cleared Apr 10, 1990
UMBILICAL CORD BLOOD SAMPLING KIT
K900302 · CBT
Ge Medical Systems Information...
Anesthesiology · 78d
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